2018 and Beyond: FDA’s New Policy and Risk-Based Strategic Regulatory Updates Under New Administration

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Feb 07, 2018
60 minutes
Product Description

Learn FDA Compliance Guidelines, Dos and Don’ts to Prepare for Risk-Based Inspections

In FDA-regulated industries, it is imperative that firms should be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is important to recognize policy changes and risk-based, strategic regulatory and compliance approaches (best practices) under the new administration.

Join this session with expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQ, who will discuss FDA’s policy changes, risk-based regulatory and compliance approaches under new administration for 2018 and beyond. This session will help youbetter prepare for and manage risk-based FDA inspection preparation and management, in a proactive and effective manner. David will share his actionable tips and advice in view of recent FDA policy changes and enforcement actions. He will help you improve your awareness and knowledge of FDA enforcement and inspection policy and risk-based approaches under the new administration.

David will discuss practical, actionable, and sustainable guidance on how to prepare for a risk-based FDA inspection and how to manage the FDA inspection process, including the dos and don’ts before, during, and after the inspection. With this session, you will become familiar with the lessons learnt from the FDA enforcement and inspection practices. David will also share his recommendations/suggestions for the dos and don’ts of PASS-IT.

Session Highlights

This session will give an overview of:

  • Laws and regulations
  • New administration
  • FDA policy
  • FDA enforcement
  • Risk-based approaches
  • Industry misconceptions
  • FDA inspection preparation and management
  • Important awareness to improve
  • Communication with the FDA
  • Employee training
  • Actual case studies
  • Speaker’s PASS-IT suggestions/recommendations and dos and don’ts
  • Conclusion

Who Should Attend

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs personnel
  • Clinical affairs personnel
  • Quality assurance personnel
  • R&D personnel
  • Consultants
  • Contractors/subcontractors
  • Anyone interested in the FDA regulatory pathways for new drugs and generics

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
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