Compliance Trainings on FDA Standards and Regulations
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Webinar on Effective Performance Management by setting S.M.A.R.T Goals

Webinar on Effective Performance Management by setting S.M.A.R.T Goals | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

A great refresher course for Executives, management members, and possibly a new concept first time supervisors, any members in an organization responsible for setting objectives for others and accountable for attaining their success.

Companies, Executives, and Management set goals for employees and the employees that are assigned the goals, many times are disappointed because they are unable to reach their objectives set forth for them by either the Board of Directors, Executives or by Management.

How can we change this around to ensure you are able to meet the objectives that are set for you during your annual review or at any time of the year?

It is important to define for the audience the difference between daily responsibilities, such as employee attendance or achieving a sales' goal/target. Discuss the difference? Some define these terms as having an intention, purpose, target, or an aim. With these terms in mind, let's introduce S.M.A.R.T. objectives. How do you define your employees' goals / objectives? A goal must be Specific? You must ensure the goal is clear and Specific.

Your employee must clearly understand what is expected. Secondly, is the goal Measurable? Typically, many managers will state, of course, it's easy if you're in Sales, but I'm in Accounting. In Accounting, our goals are not Measurable…Are you sure? Of course, percentage of invoices processed each day with less than .05% errors is a Measurable goal? The number of invoices processed is also a Measurable goal? What would happen if you are under pressure to increase the number of invoices processed daily, but cannot increase staff or improve the technology or headcount? Is the target Attainable? If your staff has been processing an average of 50 invoices daily with an error rate of less than .05% and now you increase the objective to 75 invoices with the same error rate, is the new objective Attainable? If the goal is absolutely unattainable, some of the employees will put a true effort while others will try and give up, while others they will ignore the goal all together. As a manager, your objective is to see your employees succeed and not fail.

To ensure success in reaching your goal/objective, it must have Relevance, which means you share why the objectives are Relevant to the employee, department and the company. You will be amazed at the outcome when employees are on the same pages as you and understand why together you are trying to reach a Specific objective. The Company's vision becomes owned by executives and the employees.

The Final step to the S.M.A.R.T. objective(s) is Time Bound. When is the deadline? ASAP…have different meanings for everyone? My definition of ASAP is within the next 30 minutes, the definition for my former boss' definition of ASAP was within a week or two. It has been said, a goal without a deadline, is only a dream.

How do you ensure your objectives/goals are S.M.A.R.T. goals? Practice, practice in creating S.M.A.R.T. goals. Practice makes it easier.

Areas Covered in the Session :

Art of Setting SMART goals

S - Specific

M - Measurable

A - Attainable

R - Relevant

T - Time-Bound

Allowing Managers/Supervisors a method of setting objectives & goals for employees

Making Managers and Employees accountable for their performance

Who Will Benefit:

Human Resource Professionals

HR Generalists

Managers

Supervisors

Entire Sales Team

Leaders

Newly appointed Team Lead, Supervisor, Manager

Company Heads

Management Team

Entire organization or anyone looking to improve performance management

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=HR1237

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Webinar on Customer Centricity to Quality Compliance in Healthcare

Webinar on Customer Centricity to Quality Compliance in Healthcare | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

With changing culture and healthcare reform, we are moving from a physician/provider centered focus to a customer (patient) centered focus, which means we have to change how we operate in the various functions of healthcare environments, especially in Quality Management. Quality Management, a key function in healthcare delivery, has been changing over the past couple of years. It is important that one understands the role of the 4 pillars of Quality Management and how they fit into the healthcare sector.

Attendees will gain an understanding of the changing focus in the healthcare sector; they will learn why and how we have moved from a provider-centered focus to the patient-centered focus. They will also gain an appreciation of the role of Quality Management in helping to attain a patient-centered focus, but also the various roles and responsibilities of Quality Management in the healthcare world.

Areas Covered in the Session :

What and why customer centricity is important to healthcare?

Why have we moved from provider-centered focus to patient-centered focus?

The impact that a patient-centered focused has on healthcare operations.

The role of Quality Management in shaping the patient-centered focus.

Understand the roles and responsibilities of the four pillars of Quality Management and how they fit into healthcare.

Understand tools and concepts that one can use to effectively accomplish the 4 pillars of Quality Management.

Learn what the future holds for the patient-centered focus and Quality Management role in healthcare.

Who Will Benefit:

This session is beneficial to all healthcare based companies including (but not limited to) health insurance, healthcare providers, pharmaceutical, medical supply manufacturer/suppliers, and medical device manufacturers/suppliers. The professionals who would benefit include:

Quality Management Practitioners

Healthcare Delivery

Health Insurance

Medicare/Medicaid

Department of Health

Government Health Agencies

Project Managers

Functional Managers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=HC1706

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Webinar on Training Requirements under FDA's Quality System Regulation

Webinar on Training Requirements under FDA's Quality System Regulation | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

Training requirements can make or break a firm's compliance program. A weak training program becomes a weak link in a firm's ability to make a product that conforms to FDA requirements.

An effective training program should enhance and ensure a firm's regulatory program and play a major role in supporting a firm's product, operations and the human factors environment. During an inspection, the FDA investigator may think:

Do these manufacturing employees know what they are doing?

Is the CEO's secretary qualified to manage the firm's Quality Assurance program?

Rejected products can be traced back to at least three employees X. Were they trained or retrained?

The complaint file indicates product A is associated with a lot of serious injuries and recalls. Do the employees have the knowledge, training or skills to design, make or evaluate product A?

This firm is mired in recalls. Does the firm have the technical knowledge and skill to identify the root cause and take corrective and preventive action?

Employee Z is making a lot of mistakes. Was Z trained or retrained and tested? Is there on-the-job-training supervision?

FDA regulates a medical device firm's manufacturing operations under the Quality System Regulation (QSR). (21 CFR Part 820) The regulation includes requirements for personnel training within the context of the QSR management subsystem. During an inspection, the investigator will verify that employees know and understand their firm's quality policy and check it against the firm's written policy statement. Where on-the-job training, technical skills or special knowledge are required, the investigator may ask to see and review the supporting documentation for any relevant employee. Firms that conduct training programs are expected to have written procedures to explain the training program, how it is implemented, documented and verified, either through testing or job performance review. The history of the training program should reflect an employee's duties and responsibilities throughout their employment.

FDA will look to see where training or the lack of effective training contributed to deviations from the QSR; complaints; recalls; rejected in-process goods or final product. Ultimately, the FDA investigator will use the training program findings as a reflection of whether or not a firm's management makes provisions for the responsibilities, authorities and necessary resources to establish a compliant manufacturing operation. There are other related factors that influence the success or failure of an employee training program. FDA may not raise certain less objective factors, but the human factors associated with successful or failed training may affect someone's motivation to care about training in the first place.

Areas Covered in the Session :

You should understand how the QSR personnel training requirements directly or indirectly affect a firm's conformance to all QSR requirements. The adequacy of training can bear on the quality of the products placed into the market. If your firm is involved with ongoing recalls or repetitive adverse events reports, then ask yourself whether employee training is related to a root cause?

How do you associate management responsibilities with employee training? Is it an orphaned consideration? Employee training affects FDA's evaluation of a firm's organizational management, not just the training itself as on-the-job training, academic background, technical knowledge or skills. If an employee training program is not robust, does that mean that the management does not really care in the first place? That is a fair question for the FDA investigator to ask.

Who Will Benefit:

Manufacturing Senior Managers and Supervisors

Quality Control Managers

Quality Assurance Managers and Auditors

Complaint and Recall Managers

Product Design Engineers

Personnel Department Hiring Manager

Consultants

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1557

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Webinar on Risk Based Quality Auditing

Webinar on Risk Based Quality Auditing | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

Risk Elimination. Risk Management. Risk Mitigation. This is the language of upper management, that we as auditors from any industry must learn, if we truly want to effect positive change throughout our environment.

During this presentation, the various phases of the audit process will be viewed through the lens of ISO 31000 and ISO 14971. Attendees will learn how to define, recognize, and manage risk through their audit program.  Case studies will be reviewed, as we discuss how to incorporate risk management thought, language and techniques  into our internal  audit process. In short, this presentation will show attendees how to transform an  audit program from one that is compliance based and backward facing, to one that is risk managing, continuous improvement driving and forward seeking.

We will take definitions, rationale and process structure from ISO 31000 and ISO 14971, then segue way into case studies and practical applications of incorporating risk management into the auditing process. This session IS NOT meant to be a line-by-line analysis of either ISO 31000 or ISO 14971, but rather, the standards are used to provide a logical framework to guide the discussion. The overarching goal of this session is to expand how we think about the audit process – in this case through the incorporation of risk management techniques.

Areas Covered in the Session :

Auditing fundamentals

Defining, identifying and managing risk

Risk assessment and the internal audit program

Integration of risk management into the audit program

Audit program reporting

Who Will Benefit:

Quality Auditors

Internal Auditors

Audit Program Managers

Quality Engineers

Quality Managers

Production Supervisors

Operations Managers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1890

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Webinar on Best Practices in Preparation for an FDA Computer System Audit

Description :

The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.

Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state.

There are specific best practices to be followed that will ensure you are fully prepared to defend your program and prove that you have thoroughly validated your computer systems that are subject to regulatory scrutiny. Being prepared will ensure a much easier interaction with the regulatory agency and will minimize the time and cost of the audit. A company’s readiness may also minimize the risk of findings and citations by showing the auditors that you have done due diligence and are able to respond adequately to all questions and requests for information in a timely manner.

Areas Covered in the Session :

Describe the key components and importance of regulatory audits of validated computer systems

Discuss best practices for preparing for a computer system validation audit by a regulatory agency

Provide examples of the documentation you can prepare to minimize risk and ensure your audit is successful

Discuss best practices for participating in a computer system validation audit by a regulatory agency

Provide examples of what you can do during the audit to minimize risk, time and overall cost

Discuss best practices for developing a positive relationship with regulatory agency auditors and building a reputation for preparedness, thoroughness and integrity

Interactive Q&A Session

Who Will Benefit:

This webinar is intended for those working in FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

Compliance and Audit Managers

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Clinical Data Managers and Scientists

Analytical Chemists

Laboratory Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1824

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Webinar on Deviations and Investigations

Description :

This webinar will explain the basic principles of Deviations and Investigations in the pharmaceutical and medical device industries. Particular emphasis will be the specific requirements set out in 21 CFR Part 210/211/820 and how these requirements can be met.

In this webinar you will learn the current industry standards for carrying out and documenting deviations and investigations.

Areas Covered in the Session :

SOP and documentation requirements

Training requirements

Carrying out investigations

Deviation tracking

Who Will Benefit:

Quality Control Teams

Quality Assurance Teams

Production Teams

Purchasing Teams

Operations Teams

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1723

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Webinar on Continued Process Verification - Process Monitoring

Webinar on Continued Process Verification - Process Monitoring | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

The FDA’s Process Validation Guidance calls for “Continued Process Verification” in Stage 3 of the Guidance which focuses on continual assessment of process performance and product quality throughout the life of the product. Combining process control with process improvement creates a system that satisfies the direction of ICH Q8 (R2) and FDA’s guidance for continued process verification, continuous improvement and life cycle management. This presentation describes a disciplined and structured “Quality by Design” approach to achieve this objective.

The QbD “Design Space” concept has been given much attention by pharma and biotech industries but much less attention has been given to implementation of “process control” systems needed to keep the process in-control and consistently producing quality product. Process data are routinely analyzed at two levels to assess process stability and capability. During the production of each batch data are collected by the process operators and Quality Control to assure within batch stability and capability and that appropriate actions are taken when needed. On a monthly or quarterly basis, the batch-to-batch variation in product parameters is analyzed to assess the long-term stability and capability of the process. This system is illustrated and discussed in detail. Critical questions and challenges are identified. Connections of this system to process robustness are also addressed.

Areas Covered in the Session :

FDA Guidance regarding Process Validation and Continued Process Verification

Building Blocks of QbD – Design Space, Process Control and Assessing Risk

Process Control Strategy - Stability and Capability Methods

Process Performance and Product Quality - A Systems Approach

The Vision  for Process Monitoring and Control Building Blocks

Successful Deployment, Getting Started and Sustaining the Initiative

Tips and traps – What to watch out for

Who Will Benefit:

Executives and Managers of Pharma and Biotech Companies

Process and Manufacturing Engineers

Quality Assurance Personnel

Regulatory Affairs Professionals

Quality Control Lab Personnel

Quality Engineers

Research and Development Scientists

Biologists and Microbiologists

Chemists and Chemical Engineers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1437

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Webinar on ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration

Webinar on ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2016 revision changes. There is an additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

It would be a major oversight to think of these changes as anything but a profound game-changer in terms of expectations and requirements.

Rather than wait to be surprised by unexpected requirements, or to implement them haphazardly, it is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization’s quality processes.

This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Viewing this in the context of Lean Documents and Lean Configuration will provide clarity prior to embarking upon these changes.

Areas Covered in the Session :

Brief introduction to Lean Documents and Lean Configuration

ISO 13485:2015 versus ISO 13485:2003

Overview of ISO 13485:2015

Systemic Requirements

Management Requirements

Resource Requirements

Realization Requirements

Remedial Requirements

Changes to ISO 13485:2015

Regulatory requirements

Risk-based approach

Medical device file

Record keeping

Product realization

User training

Design and development

Purchasing

Process validation

Servicing

Complaints

Delivery of nonconforming product

Improvement

How to apply the principles of lean documents and lean configuration provide a unique approach to creating continuity between the various elements of the Quality Management System (QMS) while avoiding unnecessary complexity and redundancy.

Bringing it all together

 

Who Will Benefit:

A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

Research & Development

Design Assurance

Quality Assurance

Operations

Document Control

Manufacturing Engineering

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1489

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Webinar on Computer System Validation

Description :

This course provides a background to CSV regulations and guidance on the overall process of validation and the importance of good documentation.

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected. Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product. Achieving the validated state requires much more than just User Acceptance Testing. This detailed webinar will explain the basic tenets of of 21 CFR 11 compliance for Computer Systems Validation and will show how to deliver on time and on budget while meeting regulatory compliance requirements in a more effective manner.

Areas Covered in the Session :

How big is computer system validation?

Regulatory background and useful definitions

The validation process

The importance of documentation

User Acceptance Testing (UAT)

Maintaining the validated state

Who Will Benefit:

This webinar is a must for:

Regulatory Affairs Staff

Data Managers

Clinical Affairs Staff

Clinical Research Professionals

Monitors

Programers

Statisticians

Any company that uses a computerized system to give input to new systems specifications and/or User Acceptance Testing

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1852

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Webinar on FDA Quality Metrics and Risk Based Inspections

Webinar on FDA Quality Metrics and Risk Based Inspections | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

This live training webinar will discuss the just issued (July 2015) DRAFT Guidance for Industry on “Request for Quality Metrics” along with how FDASIA is pushing it forward, review the most common Citations issued during the past several years, dissect each resultant Observation, explain the rationale behind them and present actual examples of Form FDA 483s and Warning Letters that include that particular Observation. A total of approximately 15 sections within CDER’s CFRs from each year will be examined in detail and their frequency compared against previous years.

This webinar is especially valuable to not only those within the Quality area of your Company, but also within other Departments to include Incoming Raw Materials, Manufacturing and Facilities. Because of the sensitivity and importance of understanding Quality Metrics, this live training webinar is a MUST for anyone in your organization that is involved in the management of, or recipients of Regulatory actions.

Areas Covered in the Session :

Introduction

Human Drug Establishment Inclusion & Expectations

Quality Metrics Background

Process Validation and Quality Metrics

The Use of Quality Metrics

Effects of Non-Reporting

Reporting of Quality Metrics

Review of Pertinent Form FDA 483s and Warning Letters

Summary

Who Will Benefit:

Quality Assurance Teams

Quality Control Teams

Research & Development Teams

Manufacturing Teams

Regulatory Affairs Departments

Scientists

Pharmaceutical Manufacturers

Contract Laboratories

API Manufacturers

Device Manufacturers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1812

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Webinar On Complaint Management in Accordance with 21 CFR, Part 820.198

Description : 

Lack of an effective complaint management system is a frequent Form 483 observations cited during FDA establishment inspections. In fact, failure to process complaints in a timely and uniform manner will quickly lead to other Quality Management System issues such as late Medical Device Reports (MDRs) or the potential to completely miss an opportunity to file an MDR for a serious adverse event.

If your organization is struggling with an overly burdensome complaint management system or the number of complaints is continuing to rise with no end in sight, then this webinar will provide valuable tools for optimizing your organization’s approach to complaint management.

This Webinar will breakdown the complaint management process so attendees will be exposed to a clear, concise and compliant approach to complaint management in accordance with 21 CFR, Part 820.198 requirements.

Remember, there is no such thing as maximum compliance or minimum compliance; there is just compliance when it comes to meeting the FDA’s requirements for the complaint management system.

Areas Covered in the Session :

Reviewing the Requirements Associated with 21 CFR, Part 820.198

Understanding the agency’s interpretation of processing complaints in a timely and uniform manner

Information that needs to be incorporated into a complaint file

The complaint investigative process

Processing oral complaints

Medical Device Reports (MDRs)

Use of decision trees to determine the need to report a complaint as an MDR reportable event

The documentation process for when a decision is made not to investigate a complaint

Customer response letters and follow-up

Linkage to the CAPA System

Who Will Benefit:

Quality Professionals

Regulatory Professionals

Customer Service Professionals

Medical Science Professionals

Project Managers

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1449

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Webinar on FDA Compliance and Mobile Applications

Webinar on FDA Compliance and Mobile Applications | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

Areas Covered in the Session :

Gain an understanding of how mobile applications should be handled when performing validation work

Understand the best practices for maintaining a mobile application in a validated state

Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately

Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk

Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications

Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge

Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Clinical Data Managers and Scientists

Analytical Chemists

Compliance and Audit Managers

Laboratory Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1823

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Webinar on Transforming Your Quality System from Reactive to Proactive

Webinar on Transforming Your Quality System from Reactive to Proactive | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System.

Almost daily we hear and read about companies receiving 483s, Warning Letters, and even Consent Decrees. Often executive management is surprised by these events. These companies face not only embarrassing media coverage but also costly investigations and corrective/preventive action. Quality and Compliance problems can seriously impact customer satisfaction, sales, market share, and ultimately business results. In some cases, management can face personal civil or criminal charges for failure to address issues.

So why is management surprised when they get a 483, warning letter, or consent decree?

They didn’t get the data/information identifying quality and compliance issues.The data did not clearly articulate a need or sense of urgency for improvement.

They got the information but did not effectively prioritize, resource, and implement corrective actions.

They got the information but company culture did not create an appropriate environment to clearly identify, escalate, and mitigate quality and compliance issues.

A well designed Quality Management System and program of compliance can help companies prevent issues resulting in improved product quality, customer satisfaction, and business success.

Areas Covered in the Session :

Techniques such as process monitoring, internal audit, 3rd party audit, and due diligence to monitor processes and identify areas of risk.

Using metrics/dashboards to clearly articulate quality, process performance, and results.

Warning flags that indicate a pattern of compliance issues or recidivist tendencies.

Using Management Review to clearly articulate, prioritize, and escalate areas of risk.

How a culture of quality and compliance can seriously impact a company’s ability to clearly identify and reduce compliance risk.

How to prioritize and plan improvements to quality and compliance results.

Monitoring and Controlling progress over time.

Who Will Benefit:

Quality Department

Compliance Department

Compliance Personnel performing Audits, Due Diligence, and Management Review

General Managers wanting to learn how to understand, interpret, and use information from management review to improve business resultsFor more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Implementing Medical Device Global Adverse Event Reporting Systems

Webinar on Implementing Medical Device Global Adverse Event Reporting Systems | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

The purpose of this session is to get you acquainted with adverse event reporting requirements and systems in EU, Canada and US. The obligation of Medical Device Manufacturers doesn’t end after obtaining a clearance, approval, registration, listings or certificates. They are required to report adverse events to the health authorities (e.g., Competent Authorities, Health Canada and US FDA) wherever applicable. To achieve compliance and remain compliant with adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet those prescribed requirements.

In this conference, our presenter will walk you through the applicable adverse event reporting requirements and help you understand them clearly as well as explain how to remain in conformity with the requirements in EU, Canada and US. Going further with the session, Dr. Lim will help you change your way of planning, developing, implementing and following your relevant and applicable processes so that you do it efficiently and effectively. In this conference, you will be able to become familiar with Global Adverse Event Reporting (AER) systems and also ensure if your current AER system are compliant enough.

Areas Covered in the Session :

Applicable and relevant laws and regulations in EU, Canada and US

Definitions

Medical device adverse event reporting requirements in EU, Canada and US

Medical device vigilance system during the post-production phase in EU

Mandatory medical device problem reporting requirements in Canada

Mandatory medical device reporting requirements in US

Review of actual reporting forms in EU, Canada and US

Applicable and relevant guidance documents

Common mistakes and how to prevent them

Best practices

PASS-IT solutions

Conclusion

Who Will Benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

Research & Development

Consultants

Contractors/Subcontractors

Anyone Interested in the FDA inspection Process

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Conformance of Design History Files for Mature Medical Devices

Webinar on Conformance of Design History Files for Mature Medical Devices | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are in need of bring their product design history files up to date with the current standards.

Many medical industry companies have not brought their old product lines up to current FDA standards and are not in total compliance. This webinar defines the procedures to be followed for medical products design history file remediation.

For example, companies should be compliant to ISO 13485, ISO 14971, etc. Design History Files and validations need to be updated to meet current standards. The FDA expects continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each device needs to have a gap analysis to determine obsolescence or re-validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards.

Areas Covered in the Session :

Multi-functional team approach/responsibility.

Set procedures and template to complete remediation for design history file of old devices to meet current standards.

Gap analysis

Data gathering to build the design history files

Risk procedure

Risk assessment for prioritizing remediation

Validations

Dealing with the FDA

Phase by phase check list.

Who Will Benefit:

This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with current standards. The employees who will benefit include:

Senior management

End-users responsible for design control and technical files that need to be updated to the current standards

R&D and product development

Process engineers and managers

Operations and plant management

Validation engineers

Remediation teams

Documentation teams

QA, Regulatory Affairs

QC and Corporate Auditors

All team members who contribute to design history, clinical, validations or technical files

Consultants

All Contract Manufacturers working in the medical industry

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

Webinar on Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans.

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The seminar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle such situations.

The seminar ends with a discussion of how one OEM manufacturer has implemented "confidence/reliability" calculations instead of AQL sampling plans for all of its clients.  And suggestions are given for how to use "confidence/reliability" QC specifications instead of "AQL" QC specifications. The use of "reliability plotting" for assessing product reliability during R&D is also discussed.

Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt, in order to evaluate part quality before the parts Supplier is paid.  "AQL" sampling plans are used almost universally for such inspections. However, AQL plans actually provide very little information about part quality. A better way to assess the quality of purchased parts is to use "confidence/reliability" calculations. Such calculations are very easy to perform using tables and/or an electronic spreadsheet. ISO 9001 and ISO 13485 requirements include establishing "processes needed to demonstrate [product] conformity"; FDA's GMP (21CFR820) requires that "sampling methods are adequate for their use".  An AQL sampling plan does not provide what is needed to meet either of those requirements. FDA guidelines state that "A manufacturer shall be prepared to demonstrate the statistical rationale for any sampling plan used" --- it is not possible to "demonstrate" that an AQL sampling plan ensures product quality. On the other hand, confidence/reliability calculations can be easily shown to provide evidence of product quality, and the statistical rationale for such calculations is easy to explain and demonstrate.

Areas Covered in the Session :

AQL and LQL sampling plans

OC Curves

AOQL

ANSI Z1.4

Squeglia's C=0

Confidence/Reliability calculations for

Attribute data

Normally-distributed variables data

non-Normal data

Transformations to Normality

K-tables

Normal Probability Plot

Reliability Plotting

Who Will Benefit:

QA/QC Supervisor

Process Engineer

Manufacturing Engineer

QC/QC Technician

Manufacturing Technician

R&D Engineer

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Calculating Overtime - Who Qualifies and How to Calculate Amounts Due

Webinar on Calculating Overtime - Who Qualifies and How to Calculate Amounts Due | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

An employer must pay overtime wages to all employees considered non-exempt under the federal Fair Labor Standards Act (FLSA) and numerous state laws. Although the FLSA establishes federal guidelines on who qualifies for overtime, when overtime begins and how to calculate it, state laws often differ. The US Department of Labor is stepping up its enforcement efforts to make sure employees receive the overtime pay to which they are entitled. Audits by the DOL can be random or as a result of a complaint from a laid-off worker. Either way, you need to know the law and to be prepared.

Do you know who is exempt from overtime and who is not? Do you owe overtime after 8 hours work a day or over 40 hours work in a week? What time spent by your workers counts toward the limits for regular pay? How do you calculate overtime rates for salaried vs hourly workers? What non-wage payments apply toward the overtime rate of pay?

This 90-minute webinar by payroll consultant Mark Schwartz is designed to give you the answers to these questions and evaluate your current payroll system regarding overtime calculations. Mr. Schwartz will clarify the federal rules on overtime pay, inform you how to determine what your own state’s requirements are, and point out how federal and state laws may differ.

Areas Covered in the Session :

Who are exempt vs. non-exempt workers.

Differences between federal and state laws

When does state law apply

How to determine number of hours worked before overtime must be paid.

Determining regular rate of pay.

Computing back wages for overtime purposes

Hours that are exempt for overtime purposes

Rules regarding compensatory time off

The effect on overtime calculation of stock options, commissions, and retroactive pay increases.

Penalties for non-compliance with applicable law

Who Will Benefit:

Payroll Department

Accounting Department

HR Department

Small to Medium Sized Business Owners

Payroll Apprentices

Start up Entrepreneurs

Compensation Practitioners

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Project Management for Non-Project Managers

Webinar on Project Management for Non-Project Managers | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

It is not possible to present a complete treatment of project management in the span of 60-90 minutes. It is however possible to focus in on those most critical project management aspects that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Areas Covered in the Session :

What is a project?

What is project management?

What is the project manager?

What is the PMI and the PMBOK?

The project phases

The triple constraint

Authority and responsibility

Identifying and interacting with stakeholders and why they are important

Why is effective project initiation critical to project management?

The Statement of Work

The Project Charter

Identifying project tasks

Planning for task completion – the planning tools

Controlling the project

Who Will Benefit:

This webinar is particularly suited for those with no previous project management experience. Any member from Medical device, Pharmaceutical and Biotech, Cosmetic and food, every other industry, that participates in or has the potential to manage team-based cross-functional projects, including:

Engineers

Scientists

Managers

Analysts

Associates

Newly appointed Project Managers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Effective Internal Audit Program

Webinar on Effective Internal Audit Program | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

"Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well designed audit program can be an effective tool in understanding, communicating, and reducing compliance risk.

However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. In spite of having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree.

Without an effective audit program, management is blind to many of the risks they face in delivering quality medical devices to their customers. We will discuss red-flags that indicate your audit and corrective action systems are not effectively and efficiently identifying and mitigating compliance risk. We will cover how to make your audit program meaningful and a key tool in maintaining and improving your Quality System."

Many companies are surprised when they get a 483 or Warning Letter. They have been blind to compliance risks within their own organization. This webinar can help you understand how to use Internal Audit as a powerful tool to understand, communicate, and mitigate compliance and quality issues. You will learn how to effectively and efficiently develop your audit program and reduce your quality and compliance risks. You will discover some of the "red flags" that indicate your company is taking unacceptable risks.

Areas Covered in the Session :

Risk Assessment

Developing a Structured Program

How to develop an Audit Hierarchy

Ensure Your Audit Staff is Well Trained to Proactively Identify, Communicate, Escalate Issues

Culture of Quality

Prioritize, Resources, and Implement Corrective Actions

Monitoring and Communicating Risk

Residual Risk

Red Flags

Who Will Benefit:

Compliance Managers

Quality Managers

Compliance Directors

Quality Directors

Regulatory AffairsProfessionals

Auditors

Compliance Specialists

Professionals performing due diligence and management review

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on The FDA Drug Approval Process

Webinar on The FDA Drug Approval Process | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

This web seminar provides an overview of the entire FDA Drug Approval Process. This seminar will cover FDA requirements from discovery.

We will begin by developing a molecule, testing it, going through the IND process, clinical testing and finally the NDA process. We will also discuss IND/NDA submission preparation, in-vitro studies, nonclinical studies and human clinical trials. Also discussed will be the underlying scientific and regulatory principles involved in the entire Drug Development Process. This web seminar will also provide a foundation of knowledge for those who require an understanding of the entire FDA Drug Approval Process.

Areas Covered in the Session :

Understand the FDA drug research requirements

Learn about IND process

Learn about Clinical testing requirements

Learn about NDA process

Learn about in-vitro and nonclinical testing

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Drug Discovery Personnel

Legal Personnel

Personnel who require a general understanding of the FDA Drug Approval Process

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration

Description :

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) - which is often redundant, repetitive, and chained together in a cumbersome way?

Do you find that your design and manufacturing resources are spending way too much time on documenting the CAPA process and not enough time on actually correcting and preventing systemic issues?

This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

Areas Covered in the Session :

Brief introduction to Lean Documents and Lean Configuration

Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to Corrective and Preventive Action

Alignment of the Six Sigma DMAIC approach to CAPA

Applying lean principles to documenting and tracking non-conformances

Applying lean principles to investigating and resolving non-conformances

Applying lean principles to instituting corrective and preventive actions

Who Will Benefit:

A must-attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

R&D

Design Assurance

Quality Assurance

Operations

Document Control

Manufacturing Engineering

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on ASQ Certified Quality Engineer (CQE) Exam Preparatory Course - Webinar Series

Description : 

The ASQ Certified Quality Engineer designation is a well respected and coveted designation with approximately 45,205 people holding it worldwide and 3312 per year testing for it. The certification exam is an extremely difficult test. The first time pass rate is 58% even with all of the live, online and blended training and prep courses available. Now for the first time Compliance Trainings is pleased to offer an instructor led, accelerated learning online series of webinars to prepare the experienced quality engineer to take and pass the ASQ certified quality engineer exam. For new quality engineers not yet planning to take the exam, this curriculum will provide an excellent training vehicle to new and useful tools/concepts in addition to reinforcing concepts learned in college or out on the manufacturing/service floor.

 

The bulleted items below each webinar title represent the key topics covered during each webinar but are not meant to be exhaustive of all the topics covered. Below each webinar title is indicated the section(s) of the ASQ CQE body of knowledge (BoK) that the content pertains to. The webinars are presented in a sequence to represent a logical flow and are not necessarily in the same order as listed in the ASQ CQE Bok.

 

Each webinar is two hours. Attendees will be given a quiz to turn in within one week. Quizzes will be graded and returned with comments pertaining to any questions that were incorrect. Upon conclusion of the series a 150 question final exam will be provided along with answer key.

 

Each webinar of Compliance Trainings ASQ Certified Quality Engineer (CQE) Exam Preparatory Course is scheduled every Tuesday. Students will receive Complimentary Recording access of the Live session (valid for 30 days) for reviewing the materials.

 

Areas Covered in the Session :

 

Module I - Introduction to Quality Engineering
(2 Hours)
CQE BoK Section I
Tuesday, March 8, 2016 at 11:00 Hrs

HistoryGurusDeming’s 14 pointsProject Management



Module III - Lean (2 Hours)
CQE BoK Section V
Tuesday, March 22, 2016 at 11:00 Hrs

Introduction to LeanLean ToolsImplementing a Lean programTheory of Constraints


Module V - Elements of the Quality System
(2 Hours)
CQE Bok Section II
Tuesday, April 5, 2016 at 11:00 Hrs

Quality Standards and Other GuidelinesAuditing FundamentalsRisk Based AuditingValue Added AuditingAudit ReportingCost of Quality


Module VII - Product, Process and Service
Design (2 Hours)
CQE BoK Section III
Tuesday, April 19, 2016 at 11:00 Hrs

Process Validation & VerificationReliabilityMaintainabilityTechnical Drawings & Specifications

 

Module II - Product and Process Control
(2 Hours)
CQE BoK Section IV / V / VI
Tuesday, March 15, 2016 at 11:00 Hrs

Introduction to Six SigmaBasic Statistics & SamplingSix Sigma ToolsImplementing a Six Sigma programMetrology


Module IV - Quality Tools (2 Hours)
CQE BoK Section V
Tuesday, March 29, 2016 at 11:00 Hrs

Classic 7 ToolsNew 7 ToolsQuality Tools & Risk Based Thinking



Module VI - Root Cause Analysis & Corrective Action (2 Hours)
CQE BoK Section V
Tuesday, April 12, 2016 at 11:00 Hrs

Root cause analysisRoot cause analysis toolsEffective Corrective ActionRoot Cause Analysis and Corrective Action Process



Module VIII - Risk Management (90-minutes)
CQE BoK Section VII
Tuesday, April 26, 2016 at 11:00 Hrs

Introduction to risk managementRisk management toolsDeveloping a risk management program



Module IX
Certification Exam Test Taking Tips
Tuesday, May 3, 2016 at 11:00 Hrs
Duration: 30 Minutes

 

Who Will Benefit:

This course can be used as a training course for quality engineers new in their role. It is meant to be an exam preparatory course for quality engineers having at least several years of experience.

 

Why Take This Course?

Instructor ledInstructor has 5 ASQ certifications including the CQEInstructor is ASQ sponsored instructor for the CQA preparatory courseAccelerated curriculum for experienced1 quality engineers means course is only 16 hours vs 32-40150 question final exam which includes notes that you can take into the certification examOur Guarantee – Take our course then schedule and take the exam any time in 2016. If you don’t pass, you can listen to the entire recorded webinar series for free once within the 6 months after the exam date; you will also receive a 30-minute consultation with the instructor to discuss weak areas to focus on when studying to retake the exam.Cost – save on travel and hotel costs for live courses and eliminate time away from work

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar on Interviewing Strategies: Essential Skills for Supervisors

Webinar on Interviewing Strategies: Essential Skills for Supervisors | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

Whether you are new to the hiring process or if you’re a seasoned manager or HR practitioner, you’re sure to find the powerful tips and techniques you’ll learn from Interviewing Strategies: Essential Skills for Hiring Managers to be helpful, effective, and different from what you’ve heard in other interviewing skills training.

Going beyond the basics of what not to ask interviewees, Interviewing Strategies: Essential Skills for Hiring Managers focuses on what you really need to know to conduct revealing interviews to help identify people who not only have the skills you need, but who are also the best fit for your company and your specific staffing goals.

Areas Covered in the Session :

Getting a clear picture of your interviewing goals

9 keys to effective interview preparation

8 key interviewing skills

How to choose appropriate questions and questioning techniques based on goals and criteria

Questioning approaches to avoid on order to ensure your chances of getting accurate interviewee insights

Questions interviewees are likely to ask so you can be prepared to respond

10 interviewer bias errors to avoid

5 key listening skills for interviewers to utilize

Interpreting what interviewees tell you through verbal and nonverbal communication

Considerations to use when comparing applicants

Additional tips and techniques to utilize for effective interviewing

Decision making/selection criteria

Who Will Benefit:

HR Professionals

Recruiters

Talent Acquisition Professionals

Staffing Agency Professionals

Managers

Executives

Business Owners

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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Webinar On Toyota Kata - Wax On, Wax Off (in partnership with ASQ Lean Enterprise Division)

Webinar On Toyota Kata - Wax On, Wax Off (in partnership with ASQ Lean Enterprise Division) | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description : 

What is a Kata? A Kata is something most often associated with martial arts. It is a routine you practice purposefully with intent of making that pattern a habit. Bike riding, driving and typing are all Katas. Once you learn to ride a bike and it becomes second nature, you no longer have to concentrate on the skill of riding the bike, but are now able to focus on getting to your destination.

Ask yourself what patterns exist and are reinforced in your own organization. Are these routines supportive or obstructive to meeting your improvement goals? The improvement Kata is specific routine for improving, adapting and innovating. It is scientific and goal-directed, not a random disconnected reaction to problems. The overall goal, as with any Kata, is to make the routine of the improvement Kata a habit that happens almost unconsciously. This happens through deliberate, coached practice in daily work.

This session will introduce participants to the concepts of the improvement Kata, how to use the approach to create their own internal coaches, and how companies are using the improvement Kata as a structured approach to problem solving and goal achievement.

This training is a collaboration of Compliance Trainings with

 

Areas Covered in the Session :

How to apply the Toyota Kata methodologies, models, and tools

How to use the approach to create their own internal coaches

Providing a systematic, scientific routine that can be applied to any goal

Standardizing how the members of an organization navigate uncertainty and develop solutions

Transforming managers from a role of firefighters to coach and mentor

How to conduct coaching cycles

Representing PDCA in a way that has people learning from iterative steps daily

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The professionals who will benefit include:

Quality Department Professionals

New Lean practitioners wanting to ensure an upfront culture change to drive their efforts

Those that are already further on their Lean journey and not seeing the sustaining results they’d hoped for

Those looking for a systematic approach to improvement within their organization - even if you don’t call it Lean

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=ASQ1800

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Webinar on Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9

Webinar on Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9 | Compliance Trainings on FDA Standards and Regulations | Scoop.it

Description :

The U.S. FDA has stated that the use of a medical device or pharmaceutical entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as “practical” / possible, given the ‘state of the art’ at the time. Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities, as well as CAPA resolution actions, in the company. High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to “toughen” its approach to product clearance and approval, while reducing liability issues.

ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. The degree of risk can be a determinant on the level of failure investigation, validation effort, et al, required of those activities. The resulting documentation can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.

This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product, and satisfy U.S. FDA cGMP and CE-marking / Notified Body expectations. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”.

Areas Covered in the Session :

The Revised ISO 14971 for Devices (with ALARP discussion)

ICH Q9 for Pharma

Product Hazard Analysis

Fault Tree Analysis

Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis

Suggested Risk Management File / Report, FMECA, FTA Templates

Why and How to use the ISO 14971 "Model" in all Regulated Industries

The Team and It's Involvement – Who, When and How

Using the Completed Document – It's Real Value “In the Loop”

Q & A session

Who Will Benefit:

This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their developing / reviewing / modifying their product design / formulations, manufacturing processes, and use environment in light of product risk to the end user. Also in addressing their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, Biologics and Combination products fields. The employees who will benefit include:

Senior management

Middle management

R&D

Engineering

Software

QA / RA

Manufacturing

Operators

Consultants

cGMP instructors

And all personnel involved in verification and/or validation planning, execution and documentation.

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1841

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