Preparing for 2018: FDA Inspection Policy and Best GMP Practices

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Recent FDA Policy Changes and How You Can Prepare to Embrace Them in 2018

In FDA-regulated industries, firms must understand and comply with the laws and regulations that apply to FDA-regulated medical and other products such as food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics. The FDA conducts investigations to enforce these regulations. Are you ready to tap into the opportunities and learn the lessons from FDA enforcement and inspection practices to prepare for 2018?

This session by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will discuss the FDA inspection practices to help you better prepare for and manage FDA inspections in a proactive and effective manner in 2018. You will learn actionable tips and get advice in view of the recent FDA policy changes. David will discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection. He will show you how to manage the FDA inspection process, including dos and don’ts before, during and after the inspection.

Session Highlights

  • Laws and regulations that apply for FDA-regulated medical and other products
  • Recent FDA policy changes
  • Manuals and guides to prepare for a sustainable FDA inspection
  • Managing the FDA inspection process
  • Most common deficiencies
  • Actionable inspection preparation and management tips  
  • Communication with EQ skills
  • Employee training
  • Overview of actual case studies
  • PASS-IT suggestions and recommendations

Who Should Attend

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

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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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