FDA Inspection Practices and the Top 20 Most Common GMP Deficiencies

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Jul 07, 2015
60 minutes
Product Description

How to Sustain an FDA Inspection in a Proactive and Planned Manner. Follow These Dos and Don’ts!

This conference by expert speaker Dr. David Lim will cover FDA inspection practices and the most common deficiencies for the medical device and pharmaceutical industries.This training session will help you prepare for and manage an FDA inspection in a proactive and effective manner. Dr. Lim will focus on the top 20 common deficiencies based on his analysis of 483s issued for the past several years.   

You will get actionable, practical and sustainable guidelines on how you can prepare to sustain an FDA inspection effectively and how you can manage a FDA inspection process, including dos and don’ts during and after the inspection. As a participant, you will be able to familiarize yourself with FDA inspection practices derived from deficiencies observed during the past seven years. In addition, Dr. Lim will share his valuable PASS-IT recommendations and suggestions with you.

Session Highlights:

  • Applicable Laws and Regulations
  • FDA Manuals
  • Inspection Guides
  • Hosting an FDA Inspection
  • Field Management Directives
  • Inspection Types and Categories
  • Inspection Classification
  • FDA Forms 482 and 483
  • Establishment Inspection Reports (EIRs)
  • Top twenty (20) most common deficiencies during FDA inspections for device firms and pharmaceuticals
  • How to prepare and what to prepare while managing FDA Inspections
  • The process of communicating before, after and during inspection: common do’s and don’ts
  • Inspection Preparation Procedures
  • Close Out Meeting
  • Responding to 483s, If Issued
  • How to Communicate with Emotional Intelligence
  • Employee Training
  • Actual Case Studies
  • Conclusion

Who Should Attend

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
More Events By The Speaker

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