How to Avoid: 483s, FDA Inspections, Warning Letters & Consent Decrees

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Aug 14, 2018
60 minutes
Product Description

Learn How to Develop a Compliance Program to Avoid Warning Letter and 483 Observations

U.S. Food and Drug Administration (FDA) policy is detailed and constantly shifting, yet you need a firm grasp on it to stay on the agency’s good side. FDA inspection and enforcement actions can have wide-ranging implications, and no one wants to open up a 483, warning letter, consent decree, or permanent injunction.

Regulatory and compliance expert David Lim unpacks the latest FDA guidance on inspections and regulations and reveals sound policy for how to avoid regulatory headaches.  Lim’s webinar is aimed at helping you improve your awareness about and knowledge of the FDA inspection and enforcement process. Stop worrying, and take control of regulatory compliance!

After attending this live audio event, you will understand current laws and regulations, recent changes in FDA policy and inspections, the different types of warning letters, and trends in recent inspections and enforcement actions. You will also hear about recent cases and receive Lim’s suggestions and recommendations for what you should and shouldn’t be doing.

Session Highlights

Here is a taste of what this session will reveal:

  • Laws and regulations
  • FDA policy changes
  • Changes in FDA inspection operations
  • 483s
  • Warning letters
  • Consent decree and permanent injunction
  • FDA inspection, enforcement trends in deficiencies, and how to avoid them
  • Adequate documentation
  • Communication with EQ skills
  • Employee training
  • Actual case studies
  • Speaker’s PASS-IT suggestions and recommendations for what to and not to do

Who Should Attend

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors and subcontractors
  • Anyone interested in FDA GMP inspection and enforcement

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 ( 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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