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Pharmaceutical cGMP, Data Integrity and FDA Inspections

Pharmaceutical cGMP, Data Integrity and FDA Inspections | Compliance Trainings | Scoop.it
This important seminar by an ex-FDA Investigator, is a complete guide for you and your company on cGMP Regulations Data Integrity and FDA Inspections.
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Webinar On Using Metrics to Monitor and Improve Your Quality Management System

Webinar On Using Metrics to Monitor and Improve Your Quality Management System | Compliance Trainings | Scoop.it

Scheduled On : Tuesday, September 1, 2015 at 13:00 Hrs       

 

Description :

Metrics and data are integral part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest money for improvement. Attending this course will help you to determine what to measure, how to present information, and how to escalate issues for management review.

A medical device company needs to have an efficient and effective Quality Management System (QMS) including good metrics and dashboards. Metrics and dashboards can help to proactively and consistently measure the health of the Quality Management System and prevent compliance issues. A balanced scorecard can help companies identify the top areas for improvement. Thought should be given into both lagging and leading indicators for quality and compliance.

Attend this course to learn the best practices in preparing metrics and dashboards for management review. Without proactive and timely metrics, a medical device company is blind to the health of its quality system and meeting the needs of its stakeholders. This can lead to disaster for the company or, even worse, its customers.

Challenges that companies face include:

Lack of data

Data that is not timely

Data that is incorrect or difficult to analyze

Metrics that are lagging and not leading indicators

Metrics that are not balanced leading to improper use of resources and unintended consequences

Areas Covered in the Session :

How to create a balanced scorecard

How to move from lagging to leading indicators

How to use indices or profiles to create a more complete picture of performance

Lack of transparency in quality/compliance data

Use of metrics and dashboards for management review

Maturity levels in use of metrics

Scalability and hierarchy in metrics

Who Will Benefit:

Quality Assurance Managers

Quality Control Managers

Regulatory Affairs Teams

Compliance Managers

Individuals preparing data for Management Review

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Webinar On Root Cause Analysis - Shutting Down the Alligator Farm

Webinar On Root Cause Analysis - Shutting Down the Alligator Farm | Compliance Trainings | Scoop.it

Description :

This webinar is applicable to all levels as it covers underlying principles (which are often overlooked in basic and intermediate courses) in a simplified format that does not require previous familiarity with using the tools.

A well-functioning Corrective Action program is important to any organization, particularly in a regulated industry. However, many organizations find that the number of problems encountered each month remains about the same. This is a symptom of a deeper root cause that eludes most investigations. A thorough understanding of Root Cause Analysis (RCA) is necessary to identify the deeper causes and break this cycle.

RCA is an important prerequisite for correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root of the problem and prevents true root cause analysis.

Areas Covered in the Session :

How the organizational environment encourages problems

Role of Management and system interactions in causing problems

Use of quality tools and the scientific method

Distinguishing between assignable causes, enabling factors and root causes

Case study examples

Root Cause Analysis Methods & Practical Applications

Moving from a reactive to a proactive environment

Who Will Benefit:

This webinar will benefit any organization or association that wants to improve the effectiveness of their CAPA and failure investigation efforts. The staff who would immensely benefit include:

QA Managers and Engineers

Manufacturing Managers and Engineers

Consultants

Quality System Auditors

Executives and Managers responsible for investigating and solving problems

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Webinar On Basic Requirements for IQ, OQ and PQ Quality Protocols

Webinar On Basic Requirements for IQ, OQ and PQ Quality Protocols | Compliance Trainings | Scoop.it

Description:

Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable performance according to established procedures and operational set points. This webinar will provide an outline of the typical documents used for qualification activities, the type of information normally included in each and the common deficiencies cited when audited. Attendees will be given the chance to ask questions regarding their own protocols and actual case studies will be used to highlight various points.

This webinar will highlight the importance of establishing specifications, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.

Any equipment, system or utility used for GMP impacted products or services must demonstrate they are suitable for their intended use and operate according to their design. To prove these requirements, the protocols developed for both installation and operational verification (and others) are expected to be in place and approved prior to use. This webinar, designed for those just starting to be responsible for qualification activities, will help establish an outline of the basic components for these two protocols. In addition, common deficiencies cited by regulators will also be reviewed in order to help attendees avoid similar issues when their protocols are audited.

Areas Covered in the Session :

Review common protocol types and the typical information included in each.

Discuss common deficiencies cited with each type.

Review how best to summarize results and the handling of deviations encountered

Discuss questions that attendees may have regarding their current practices.

Who Will Benefit:

Quality Assurance Teams

Quality Control Teams

Manufacturing Teams

Production Teams

Regulatory Teams

Laboratory Personnel

Management Teams

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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 | Scoop.it

Scheduled On : Wednesday, September 16, 2015 at 13:00 Hrs 

 

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

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FDA 510(k) Requirements, Submission, and Clearance: Best Practices

FDA 510(k) Requirements, Submission, and Clearance: Best Practices | Compliance Trainings | Scoop.it

Scheduled On : Friday, September 18, 2015 at 13:00 Hrs

Description :

This presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.  On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.

From this webinar, you will

Gain and receive great guidance on 510(k) preparation, submission and clearance

Get the latest information

Learn the critical areas and common mistakes

Improve your current practice

Recognize what is important

Become better aware of and get familiar with the 510(k) process and much more.

 

Areas Covered in the Session :

Applicable statute(s), regulations, and definitions

Device classification

Who is subject to a 510(k)

FDA guidance for 510(k) program

What actions require a 510(k) including three types of 510(k)s

How to identify a predicate(s), if any.

510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA

e-Copy Program

Product type-specific 510(k) contents-recently cleared

What to include and address in 510(k) submissions.

510(k) contents and format

How to present scientific, technical, and/or clinical data.

How to demonstrate substantial equivalence (SE).

How to increase 510(k) submission quality.

How to respond to FDA’s request of additional information.

How to resolve different opinions between the submitter and FDA reviewer(s), if any.

PASS-IT suggestions/recommendations

 

Who Will Benefit:

Medical Device Quality and Compliance Professionals

Pharmaceutical Compliance Professionals

Quality

Regulatory Affairs

CEOs

VPs

Attorneys

Clinical Affairs

Research & Development

Consultants

Contractors/Subcontractors

Anyone Interested in the 510(k) Matters


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Webinar On Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration

Webinar On Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration | Compliance Trainings | Scoop.it

Scheduled On : Wednesday, September 23, 2015 at 13:00 Hrs       

 

Description :

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.

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - 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 documentation and not enough on engineering and design?

This must attend webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative, applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration, that avoids many of the pitfalls of traditional ways of preparing these Key Regulatory 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 DHF, DMR, and DHR

Design History Files (DHF) content, development, and management

Device Master Records (DMR) content, development, and management

Device History Record (DHR) content, development, and management

Applying lean principles to creating, developing, and managing a DHF

Applying lean principles to creating, developing, and managing a DMR

Applying lean principles to creating, developing, and managing DHRs

Who Will Benefit:

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

R&D

Manufacturing Engineering

Design Assurance

Quality Assurance

Operations

Document Control

Lean Program Leaders

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Webinar On Seven Step Compensation Diet

Webinar On Seven Step Compensation Diet | Compliance Trainings | Scoop.it

Scheduled On : Friday, September 25, 2015 at 13:00 Hrs

Description :

If you do have a bloated payroll, or if you fear a growing loss of control over your company's largest single expense item (employee pay), then you should consider having your organization go on a diet - the Seven Step Compensation Diet.

Attendees will first learn what to look for, to gauge the extent of the "challenge' ahead of them. What compensation programs are broken, which might be bent, and what just doesn't work as well anymore.

From there we will take a step-by-step approach to getting your compensation affairs (and programs) in order. These steps are building blocks, each placed upon the other, establishing a firm foundation of good practices, management discipline and a focus on what is needed to ensure and maintain organization success.

Each step focuses on a particular fundamental criteria for successful compensation programs, about getting things right, and answers the why? question.

Participants will be challenged to change their behavior, and to encourage that others, especially leaders, change as well. In effect practitioners and managers alike will have to stop doing certain things (select policies, practices, procedures, custom & practice) and start doing others.  Start doing something new. Or else you will fail.

You will hear practical advice that you can start to implement that very day. If you follow the diet, you can get your arms around (better control) your payroll issues, as well as morale, engagement, turnover and productivity issues as well.

Areas Covered in the Session :

Why management sometimes needs to go on a compensation diet

How effective are my pay programs?

Should you have a compensation strategy?

The advantage of having written policies, procedures and how-to instructions for managers

What is Position Control and how it can help

How to use and not abuse a budget

Building a storyboard with metrics

What it means to stay the course

A dieter's success story

Who Will Benefit:

This is a must attend webinar for all:

Compensation Practitioners

HR Generalists

Accounting Personnel

Human Resources

Compensation Managers

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Webinar On Drug Master Files: New Implications under GDUFA

Webinar On Drug Master Files: New Implications under GDUFA | Compliance Trainings | Scoop.it

Scheduled On : Friday, October 2, 2015 at 13:00 Hrs       

 

This webinar will help you have a better understanding of GDUFA, its implications regarding DMFs, who in industry is impacted, the required fees, and achieving DMF “Available for Reference” status.

Areas Covered in the Session :

Generic Drug User Fee Amendments: Background

Key definitions

Who in industry is impacted

Self-identification and fee requirements

New DMF correspondences and meetings

Completeness assessments

“Available for Reference” status

Who Will Benefit:

Regulatory Affairs Teams

Project Managers

QA & QC Managers

API manufacturers

Generic drug manufacturers

Type II (API) DMF holders

ANDA Sponsors

Consultants

Any individuals interested in the generic drug industry

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Webinar On Risk Management in Clinical Trials

Webinar On Risk Management in Clinical Trials | Compliance Trainings | Scoop.it

Scheduled On : Monday, October 5, 2015 at 13:00 Hrs       

 

Description :

ICH Q9 – Quality Risk Management has been present as an FDA Guidance

Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodology across all aspects of the pharmaceutical industry; which of course includes R&D and clinical trials. This risk management methodology achieves identification of risks, an analysis step and then  deciding actions to be taken on the most significant. This process ensures that resources are not wasted on doing things that are not delivering benefit in mitigating significant risks.

This webinar will refresh basic Risk Management methodology and then establish how this fits in with the standard stages of a clinical trial. Regulatory inspectors will now expect to see evidence of a risk based approach to a clinical trial, and this course will address the topic of documentation to be created.

Areas Covered in the Session :

Risk management methodology

Utilize the basic principles to take a 'risk-based approach'

Document risks identified

Prioritise risks and plan mitigation actions where necessary

Who Will Benefit:

Data management Teams

Clinical Research Associates

Monitors

Project Managers

Statisticians

Academic Research Organizations' Staff

Representatives of any CROs or other contractors (ePRO etc) who will be supporting clinical trials

Researchers within a healthcare setting

And all clinical research professional embarking on a risk-based approach

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Webinar On U.S. FDA Project Management

Webinar On U.S. FDA Project Management | Compliance Trainings | Scoop.it

Scheduled On : Wednesday, October 7, 2015 at 13:00 Hrs       

 

Description :

This webinar is not a project management certification course. However, it is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. Lean and Agile principles will be discussed, including potential pitfalls. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

The FDA expects companies to manage projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards.  The EU MDD and their notified bodies are no different.

How can this be done from a project's inception?

How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms?

How to minimize scope creep?

What are the "lean" and "Agile"  benefits and shortcomings in the cGMP environment?

What is "failing fast" in the "build-measure-learn, re-evaluate / decide loop?

How to gain management support for the Milestones, Tasks, Timelines?

Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not rocket-science, but require the implementation of formal methods with documented, and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan".

Areas Covered in the Session :

The three most common PM tools -- Gantt, CPM, PERT + others

Work breakdown structure, milestones, tasks

Lean and Agile principles, advantages and potential problems

Drive success over failure fast

The build, leisure, learn,  re-evaluate loop

A template / example

One major but often neglected use

 

Who Will Benefit:

Principles in this webinar will apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:

Senior management

Middle management

R&D

Engineering

Software

QA / RA

Manufacturing Teams

Operations Teams

Consultants

cGMP instructors

Production Teams

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Webinar on Design Verification, Validation and Testing for Medical Devices

Webinar on Design Verification, Validation and Testing for Medical Devices | Compliance Trainings | Scoop.it

Scheduled On : Wednesday, October 14, 2015 at 13:00 Hrs       

 

Description :

Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfill its mandate for safety and efficacy of all medical devices. The design controls are now being expected from outside equipment manufacturers (OEM) and suppliers to the medical device industry. This webinar will educate you on the key areas that you need to focus on to fulfill the design control requirements for your medical device at various phases of your product development.

Areas Covered in the Session :

Product development process overview

Applicable design verification and validation requirements

Testing requirements including the pertinent ISO guidelines

Translation of user requirements into design inputs and role of testing and regulatory requirements

Focusing on critical to customer and critical to quality requirements

Design verification and design validation activity cycles

Traceability and risk management at all stages

Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)

Proof for how design outputs meet functional and operational requirements

Compatibility of the design with components and other accessories

Test requirements to fulfil acceptance criteria for final products

How to withstand regulatory scrutiny

How are changes and their effects controlled and documented during the device life cycle?

Summary

Who Will Benefit:

Senior management

Middle management

Research & Development

Quality Engineers

Manufacturing Engineers

Regulatory Affairs Professionals

Quality Assurance & Quality Control Personnel

Device Design Team

Device Development Team

Device Manufacturing Team

Verification and/or Validation planning, execution and documentation for devices.

Startup Company Leaders

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Webinar On Here Today Gone Tomorrow: Tools for Managers & Human Resource Professionals to Navigate Change

Webinar On Here Today Gone Tomorrow: Tools for Managers & Human Resource Professionals to Navigate Change | Compliance Trainings | Scoop.it

Scheduled On : Tuesday, October 20, 2015 at 13:00 Hrs       

 

Description :

As a manager, one of your most important roles is helping your employees successfully navigate change. Change is usually both a positive and negative experience. At first, employees may resist change and cling to their old ways. It is your job as manager or human resource professional to help them see how change can help them, not hurt them. In this program, Judi Clements helps you do just that. First you’ll learn how to deal with your own reactions to change and how to develop a transitional approach. Then you’ll learn how to help individual employees and teams gain new competences, reverse resistance, and gain confidence in an ever-changing workplace.

To help managers & Human Resource professional develop the skills to recognize the need for change and navigate the stages of changes successfully and efficiently; to help staff accept change and acquire the skills & abilities to accept, learn, & grow from change.

Areas Covered in the Session :

Manage your reaction to change

Avoid common mistakes when managing change

Communicate change effectively

Use a transitional approach to implement change

Help employees navigate the 4-Stages of Change

Reverse employees’ resistance to change

Involve employees in the change process

Make change a positive experience for employees & your organization

Contribute positively to organizational change in your Human Resources role

Who Will Benefit:

Senior HR Professionals

HR Analysts

HR Managers & Directors

HR Personnel

Employee Relations Professionals

Directors

Vice Presidents

President

Managers

Shift Leaders

All Employees

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Webinar On FDA Good Laboratory Practice

Webinar On FDA Good Laboratory Practice | Compliance Trainings | Scoop.it

Scheduled On : Tuesday, September 1, 2015 at 13:00 Hrs       

 

Description :

Understanding the regulatory requirements set out under good laboratory practice (GLP) regulations is important so that the GLP requirements can be adequately implemented, helping to streamline regulatory processes and to save a significant time and effort during the process.

This webinar is intended to help industry get better familiar with the GLP requirements from practical perspectives.

This 60-min presentation will provide great opportunities to get familiar with GLP regulatory and compliance requirements applicable to many industries (drugs, biologics/biosimilars, and medical devices including IVDs, etc.).

This webinar is a must for professionals who are involved in studies subject to GLP regulations including anyone interested in the topics from other industry.

Areas Covered in the Session :

Laws and Regulations

Definitions

GLP Regulations

GLP Requirements

Compliance to GLP Regulations

FDA Guidance and Standards

Best Practices: Dos and Don’ts

Speaker’s Recommendation and Suggestions on PASS-IT Solutions

Who Will Benefit:

R&D

Quality

Regulatory Affairs

Compliance Officers

CEOs

VPs

Attorneys

Complainant Managers

Managers (RA, QA/QC, CA)

Consultants

Contractors and Subcontractors

Anyone interested in the topic

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Webinar On Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements

Webinar On Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements | Compliance Trainings | Scoop.it

Scheduled On : Wednesday, September 2, 2015 at 13:00 Hrs       

 

Description :

This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning.

And now, the FDA is taking an even tougher stance.

Why do companies need a Master Validation Plan?

What are the "must have" elements from  the cGMPs?

How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?

How can these be integrated into the company's quality management system?

Areas Covered in the Session :

Verification and Validation -- Recent Regulatory requirements.

The Master Validation Plan(s).

Product Verfication & Validation.

Process and Equipment Verfication & Validation.

QMS V&V and 21 CFR Part 11.

When and How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents.

The 11 Elements of the FDA's Software VT&V "Model".

Incorporate the Hazard Analysis / Risk Management tools of ISO 14971 and ICH Q9.

Avoid recent compliance problems.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:

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.

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Webinar On Laboratory Accreditation: Getting there is Just the Beginning

Webinar On Laboratory Accreditation: Getting there is Just the Beginning | Compliance Trainings | Scoop.it

Scheduled On : Friday, September 11, 2015 at 13:00 Hrs

 

Developing a Quality Management System (QMS) as a prerequisite for getting accredited is relatively easy. Maintaining the QMS to retain your accreditation status is the real challenge and a measure of the robustness your System.

Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits.

Why do you want to become accredited?

Where do you start?

For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? Getting there is relatively easy. Staying there is hard part.

 

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Areas Covered in the Session :

Defining a Quality Management System (QMS)

Management Components of a QMS

Technical Components of a QMS

Method Selection, Validation and Verification

Ensuring analytical competency

Ensuring analyst competency

Who Will Benefit:

Laboratory Management/Supervision

Laboratory Quality Development

Laboratory Quality Management

Laboratory Quality Control

Analytical support

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

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=FDB1492

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Webinar On Highest Risk Factors with HIPAA

Webinar On Highest Risk Factors with HIPAA | Compliance Trainings | Scoop.it

Scheduled On : Tuesday, September 15, 2015 at 15:00 Hrs       

 

Description :

This lesson will be addressing the highest risk factors you have and how to mitigate. It will also address major changes under the Omnibus Rule and any other applicable updates of 2015. There are an enormous amount of issues and risks for covered entities and business associates under Omnibus, first and foremost being the Feds have and increased budget and enforcement abilities using outsourcing.

In this session you will understand:

What are your highest risk factors?

New laws and funding mean increased risk!

HIPAA Omnibus - Do you know what's involved and what you need to do?

What does Omnibus mean for covered entities and business associates?

Why should you be concerned?

Do you know patients will have more legal recourse to sue for wrongful disclosure?

Court cases that are changing the landscape of HIPAA and patient's ability to sue

Areas Covered in the Session :

Updates for 2015

Fines

Business associates and the increased burden

Breach notification

Paperwork that needs to be updated

Risk factors

 

Who Will Benefit:

Practice Managers

Any Business Associates who work with Medical Practices or Hospitals

Billing Companies

Transcription Companies

IT COompanies

Answering Services

Home Health

Coders

Attorneys

MD's and other Medical Professionals

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Webinar Application of Lean Six Sigma Methodology for Regulated Industries

Webinar Application of Lean Six Sigma Methodology for Regulated Industries | Compliance Trainings | Scoop.it

Scheduled On : Thursday, September 17, 2015 at 13:00 Hrs       

 

Description :

This course teaches any employee the Lean Six Sigma philosophy and how to apply it in their job on a day-to-day basis. Participants will learn each phase of Six Sigma's DMAIC methodology and their use as a part of the continuous improvement program. Students will understand how implementation of Lean Six Sigma method ties directly to and demonstrates compliance with the core principles of ISO 9001 and its sister ISO Quality Management System (QMS) standards. Participants will also leave this course with an understanding of overview of Lean Six Sigma tools, methods and their application as well as, effectively engage under supervision in their organization’s continuous improvement program.

Areas Covered in the Session :

Overview of Lean Six Sigma

The meaning and use of Lean Six Sigma philosophy

Communicate using Lean Six Sigma concepts.

Relate Lean Six Sigma concepts to the overall business objectives.

How Lean Six Sigma demonstrates alignment with core ISO qms principles

How to use the five-step D-M-A-I-C method to improve processes.

How to map a process and understand its inputs and outputs

How to draft a project charter

Overview of design of experiments (DOE)

Overview of failure mode and effects analysis (FMEA)

Overview of measurement system evaluation (MSE)

How to engage in a meaningful way in ongoing continuous improvement projects

Who Will Benefit:

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

Those seeking to improve their process improvement skills

Those wanting a basic understanding of Lean Six Sigma philosophy, tools and methods

Those who want to demonstrate effective compliance to ISO core principles

Those who want to be able to actively participate in their organization’s six sigma program

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Webinar On Creating and Maintaining a GMP Quality System

Webinar On Creating and Maintaining a GMP Quality System | Compliance Trainings | Scoop.it

Scheduled On : Wednesday, September 23, 2015 at 13:00 Hrs       

 

Description :

The webinar will discuss basic/key requirements for creating and maintaining a GMP compliant quality system in the FDA regulated industries.

In this webinar,

You will gain the knowledge base for operating in a GMP compliant environment

You will have a better understanding of the basic requirements that FDA seeks in the FDA regulated industries

Speaker will layout the basic knowledge base for the top requirements for a GMP complaint quality management system (QMS)

Areas Covered in the Session :

Good Manufacturing Practices - Overview

Quality Management System - Overview

Key requirements for creating an FDA compliant Quality Management System

Prerequisites for meeting GMP compliance

Interactive Q&A Session

Who Will Benefit:

Quality Assurance Professionals

Quality Control Professionals

Regulatory Professionals

Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams

Pharma/Medical Devices/OTC Cosmetic Packaging Teams

Pharma/Medical Devices/OTC Cosmetic Subcontractors

Contract Testing Laboratories

Owners/Presidents of GMP regulated companies

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Webinar On Calibration and Qualification in Analytical Laboratories

Webinar On Calibration and Qualification in Analytical Laboratories | Compliance Trainings | Scoop.it

Scheduled On : Thursday, September 24, 2015 at 13:00 Hrs       

 

Description :

Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.

For easy implementation, attendees will receive

2 SOPs

Change control for analytical equipment

Allocating Analytical Instruments to USP <1058> Categories

20+ Examples for Instrument OQ Testing

Areas Covered in the Session :

Lab equipment requirements for calibration and qualification

Most common inspection problems

USP Chapter <1058>: Analytical Instrument Qualification

Development of an effective equipment qualification master plan

Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification

Allocating equipment to qualification categories A, B and C

Qualification and documentation requirements for each category

Going through the category example list

Approach for existing systems

Approach for automated systems (incl. firmware/computer systems)

Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)

Documentation requirements

Update on the new revision of USP <1058>

Who Will Benefit:

A must attend webinar for professionals in Small, midsize and large Pharmaceutical companies, API manufacturers, Clinical testing laboratories and Contract manufacturers and laboratories. Those who will benefit the are:

QA Managers and Personnel

Analysts and Lab Managers

QA Managers and Personnel

Regulatory Affairs

Training Departments

Documentation Departments

Consultants

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Webinar On Due Diligence - Quality and Compliance Aspects for Medical Devices

Webinar On Due Diligence - Quality and Compliance Aspects for Medical Devices | Compliance Trainings | Scoop.it

Scheduled On : Thursday, October 1, 2015 at 13:00 Hrs       

Description :

Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly help you avoid that disaster and help you improve your business success.

Mergers and acquisitions are an on-going and important part of the medical device industry. And Due Diligence is a critical part of that process, setting the stage for either success or disaster. Poor due diligence can lead to quality (ex. Recalls) or compliance (ex. Warning letter or Consent Decree) problems years after an acquisition.

In this webinar, we’ll discuss the Quality/Compliance aspects of Due Diligence for Medical Device companies. We’ll learn from real examples what can go wrong in Due Diligence leading to problems later on. Then we’ll discuss how to prepare, conduct, and report a meaningful Due Diligence. We’ll discuss ways to prioritize issues into those that affect the deal and valuation, and those that should be taken care of short and long term post acquisition.

Areas Covered in the Session :

Due Diligence Expectations and planning

Team requirements

Lessons Learned from Acquisitions

Red Flags of Quality / Compliance Issues

How to categorize / prioritize Issues

Check List for Due Diligence

Risk Management

Preparing Recommendations for M&A

Preparing Action plans for post-acquisition

Who Will Benefit:

Due Diligence team members

Quality Engineers

Compliance Specialists

Compliance Managers

Quality Managers

Attorneys

Consultants and Contractors

Business Leaders wishing to develop an M&A program

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Webinar on Extending Drug's Life

Webinar on Extending Drug's Life | Compliance Trainings | Scoop.it

Scheduled On : Monday, October 5, 2015 at 13:00 Hrs       

 

This webinar is for all involved in drug development

Description:

This webinar will describe how a pharmaceutical company can prolong the life of a drug product. The high cost of time, money, and man-hours to develop a new pharmaceutical drug requires that the company hang onto the drug especially during the patent period. Examples will include new formulations, indications, and additional patient populations. Healthy pharmaceutical companies take pride in adding years to a drug’s patent process life. People who are responsible for this result are often promoted because of the positive effect on the company’s health.

Areas Covered in the Session:

This webinar will describe how a pharmaceutical company can prolong the life of a drug product using:

New formulations

Indications

Additional patient populations

Who Will Benefit:

Project Managers

Formulation Development Departments

Preclinical Development Departments

Clinical Development Departments

Regulatory Compliance Departments

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Webinar on Changes under the HIPAA Omnibus Rule - What's New

Webinar on Changes under the HIPAA Omnibus Rule - What's New | Compliance Trainings | Scoop.it

Scheduled On : Tuesday, October 6, 2015 at 13:00 Hrs       

 

Description :

This lesson will be addressing the major changes from the September 23rd 2013 HIPAA Omnibus Rule and any other applicable updates at the time of the presentation. There are an enormous amount of issues and risks for covered entities and business associates under Omnibus, first and foremost being the Feds have and increased budget and enforcement abilities using outsourcing.

HIPAA Omnibus - Do you know what's involved and what you need to do?

What does Omnibus mean for covered entities and business associates?

Why should you be concerned?

Can patients now sue you for wrongful disclosure?

Areas Covered in the Session :

Omnibus changes and applicable other changes

Fines

Business associates and the increased burden

Breach notification

Paperwork that needs to be updated

Risk factors

Who Will Benefit:

Practice Managers

Business Associates

Home Health

Coders

Attorneys

MD's

Medical Professionals

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Webinar On Big Data and its Importance to Quality And Compliance

Webinar On Big Data and its Importance to Quality And Compliance | Compliance Trainings | Scoop.it

Scheduled On : Wednesday, October 14, 2015 at 13:00 Hrs       

 

Description :

This session will encompass in-depth discussion around the topic of what big data is, how it impacts the industry, and how it can be used to accomplish goals for an organization. More specifically, much of our time will be spent discussing how big data impacts quality and compliance in any industry and how it can be used to address many of the requirements of quality and compliance in the industry. We will also discuss how big data can be used to drive improvement in the areas of quality and compliance for your company.

Gain an understanding of big data and learn why it is importance to several aspects of a business, especially quality and compliance. One can learn how big data relates to quality and compliance and how it can be used to address many of the requirements of quality and compliance in the industry.

This session will benefit any person who is in a leadership or managerial role that needs to address quality and compliance, any analytical person who needs to work with big data, and any improvement specialist that needs to utilize big data to drive improvement in quality and compliance.

Areas Covered in the Session :

Big Data - Overview

How can big data be used in industry?

How does big data relate to quality and compliance?

How can big data be used to drive improvement in quality and compliance?

Best Practices

Interactive Q&A session

Who Will Benefit:

Project Managers

Functional Managers

Analysts

Quality Managers

Compliance Teams

Quality and Compliance Change Agents

Research & Development Teams

Quality Analysts

Marketing Teams

Senior Management

Startup Company Leaders

Consultants

Anyone interested in Big Data

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Webinar On Good Documentation Practices

Webinar On Good Documentation Practices | Compliance Trainings | Scoop.it

Scheduled On : Friday, October 16, 2015 at 13:00 Hrs       

 

Description :

The webinar will discuss basic/key requirements for writing SOPs, recording data, completing forms and other basic documentation requirements for the GMP compliant company. Furthermore, the current industry requirements for recordkeeping will be discussed.

In this webinar,

You will be shown the benefits of good documentation practices in the GMP environment

You will gain a knowledge base for controlling and handling documents in a GMP compliant environment

You will have a better understand the basic requirements that FDA seeks for all records, documents, forms and procedures to meet GMP requirements

You will be guided on how to ensure the quality and consistency of processes/activities/manufacturing

Areas Covered in the Session :

Good Documentation Practices Do’s and Don’ts

cGMP requirements for changing and controlling entries into documents

Archiving of records

Current industry practices for GDP

Interactive Q&A Session

Who Will Benefit:

Quality Assurance Professionals

Quality Control Professionals

Regulatory Professionals

Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams

Pharma/Medical Devices/OTC Cosmetic Packaging Teams

Pharma/Medical Devices/OTC Cosmetic Subcontractors

Contract Testing Laboratories

Owners/Presidents of GMP regulated companies

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