Anticipation and Expectations of a Medical OEM Design Control Audit
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Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory | Anticipation and Expectations of a Medical OEM Design Control Audit | Scoop.it

Description:

 This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.  

Course Objective:

 This laboratory inspection course is designed to provide participants with an understanding of the areas which are likely to be the subject of a laboratory inspection, whether it is a Pre-Approval Inspection or a general GMP inspection. By understanding the expectations, the participants will be able to develop a strategy to minimize issues should their laboratory be inspected.Upon completion of this course the participant should:Be familiar with the areas in which regulatory inspectors are likely to probe.Be aware of the general expectations for each of these areas.Develop an overall strategy to minimize the likelihood of issues arising during an inspection.Due to the diverse interests of the participants, questions will be actively solicited and addressed by the end of the webinar  

Course Outline:

 Types of Inspections.Personnel Organization and Records.Instrument Inventory, Qualification and Change Control.Key SOPs Every Lab Should Have, and Related Training and Maintenance.Log of Out of Specification Results.Documentation of Analytical Procedures, including Validation, Verification and Change Control.Documentation of Analytical Data and Reports.Trending of Analytical Data, Laboratory Incidents and OOS Reports.Brief Introduction to Expectations for Computer Systems.Attendee Questions and Answers.
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Target Audience:

 ChemistsLaboratory ManagersRegulatory AffairsQuality Assurance personnel responsible for generating GMP or GLP data or assuring readiness for a regulatory inspectionIT/ISDocumentation 

For More Details or Enrollment Or Registration :

Contact : complianzworld

Phone : +1-866-978-0800

Fax : +1-866-978-0800 

E-mail ID : webinarhelp@complianzworld.com

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FDA Inspection Preparedness: Mistakes and Sustainable Actions with Do's and Don'ts

FDA Inspection Preparedness: Mistakes and Sustainable Actions with Do's and Don'ts | Anticipation and Expectations of a Medical OEM Design Control Audit | Scoop.it

Description:

 This webinar is intended to help both medical device and pharmaceutical industry get familiar with FDA inspection process so that it can be adequately prepared with readiness anytime, and managed in a proactive and effective manner.This webinar discusses practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection. Course Outline: Applicable LawsFDA RegulationsFDA Information (IOMs, Inspection Guides, FMD and CPGM)FDA Inspection LogisticsInspection Types, Categories and ClassificationFDA Forms 482, 483 and EIRsWhat/How to Prepare for and Manage an FDA InspectionCommunication Before, During and After FDA Inspection: Dos and Don’tsClose Out Meeting
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Target Audience:

 Medical Device Quality and Compliance ProfessionalsPharmaceutical Compliance ProfessionalsQualityRegulatory AffairsCEOsVPsAttorneysClinical Affairs

 

For More Details or Enrollment Or Registration :

Contact : complianzworld

Phone : +1-866-978-0800

Fax : +1-866-978-0800 

E-mail ID : webinarhelp@complianzworld.com

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Evaluating a contract lab using system based approach

Evaluating a contract lab using system based approach | Anticipation and Expectations of a Medical OEM Design Control Audit | Scoop.it

Description:

This session will discuss key concepts when evaluating a contract lab and key issues when working with an external analytical laboratory.


Course Objective:

 Capacity is a key issue to drive company to outsource therefore, contract labs have become an integral part of pharmaceutical industry.  Companies now faced critical timelines, limited resources and expertise; thus many have turned to contract labs for additional support.  Therefore, evaluating and selecting a contract lab become a critical activity. Course Outline: System-Based Inspection?Select a CROPerform a technical evaluationAudit a CRO for analytical testingYour SOPs or mines?How to communicate expectationsHow to monitor the process Target Audience: This session will benefit :-Analytical chemistsRegulators.Researchers who are involved in inspections. You must have at least 2 years experience in pharmaceutical industry to get the full benefit of this discussion.


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For More Details or Enrollment Or Registration :

Contact : complianzworld

Phone : +1-866-978-0800

Fax : +1-866-978-0800 

E-mail ID : webinarhelp@complianzworld.com

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Handling Supplemental Pay Under the FLSA

Handling Supplemental Pay Under the FLSA | Anticipation and Expectations of a Medical OEM Design Control Audit | Scoop.it
Complianzworld's insight:

This session will help you understand areas such as when employees have to be paid to get dressed and undressed; when you have to pay them to be on an airplane and when you don’t; what breaks need to be paid and what breaks don’t need to be paid; why you have to pay for breastfeeding; and other areas of supplemental pay. Reduce your chances of being investigated by making sure you pay practices are in compliance.


Target Audience:

 The key audience includes everyone who is responsible for insuring compliance with the Fair Labor Standards Act. This includesVice Presidents of HRHuman Resource ManagersHR generalistPayroll administratorsOffice managersAccounting managersOperations managers


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