Best Practices for FDA Inspection Readiness and Management - Dos and Don

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Thu, Jul 31, 2014
60 Minutes
Product Description

All you need to know to get your Organization ready for FDA Inspection and adequately manage it

Get both medical device and pharmaceutical industry familiar to the ‘Best practices’ for FDA inspection, making them ready for an inspection anytime in an effectively, sustainable manner.

The aim of this presentation is to discuss actionable, practical and sustainable ways to prepare for a favorable FDA inspection and to efficiently manage the process which includes Dos and Don’ts before, after and during the inspection.

Join Dr. David Lim, Ph.D., RAC, ASQ-CQA in this session where he will help you be familiar with the best practices and to get ready for an FDA inspection and adequately manage it. David will share all new information which is useful for you to consider and greatly improve your current FDA inspection readiness process and management.

Training Objective:

  • Applicable laws and regulations
  • FDA manuals
  • FDA inspection logistics
  • Inspection types, categories and classification
  • FDA Forms 482, 483 and EIRs
  • FDA inspection preparation and management
  • Effective communication before, during and after FDA inspection: Dos and Don’ts
  • Close out meeting
  • Responding to 483s, if issued
  • Emotional intelligence-based approaches
  • Common mistakes and how to avoid them
  • Best practices to prevent common mistakes in 483s
  • Best practices for achieving compliance and staying compliant
  • PASS-IT suggestions and recommendations

Who Should Attend

  • Medical Device Quality and Compliance Professionals
  • Pharmaceutical Compliance Professionals
  • Quality
  • Regulatory Affairs
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA inspection Process (Pharmaceuticals)

Get answers to your questions in a Q&A segment after the session by the 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 ( 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
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