Recent Changes and Trends in FDA Regulations on GLP, GCP and cGMP

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Thu, Nov 08, 2018
60 minutes
Product Description

Learn the Best Practices to Avoid 483s and Warning Letters

To be on the FDA’s right side, it is imperative that you stay current with the agency’s evolving regulations governing good laboratory practice (GLP), current good manufacturing practice (cGMP), and good clinical practice (GCP). FDA-regulated businesses that fail to keep pace with the changes often end up with 483s and warning letters. The consequences can be quite costly—both in terms of time and money.

Learn how to avoid regulatory headaches in this webinar with regulatory and compliance expert Dr. David Lim. Catch up on the latest FDA guidance on GLP, cGMP, and GCP – with practical insights on the key requirements you should be aware of.

Learn the best practices on how to implement GLP, GMP and GCP guidelines, how to remove problem conditions, and how to implement a timely corrective action plan. Find out which recent FDA enforcement trends have helped improve awareness and led to better, more informed business decisions.

Take control of your compliance programs with practical, actionable, and sustainable insights on the latest FDA regulations that impact your business, along with Lim’s practical PASS-IT recommendations/suggestions—including the dos and don’ts that you won’t want to miss!

After attending this webinar, you will be confident in your ability to demonstrate FDA-compliant implementation and practice of GLP, GMP and GCP. Plus, you’ll know how to implement a corrective action plan that helps you stay out of trouble.

Session Highlights

Here’s a sample of some of the topics covered in this session:

  • Important laws and regulations
  • Definitions you should know
  • Changes/updates to FDA Regulations (GLP, GMP, and GCP)
  • Recent FDA enforcement trends for pharmaceuticals and medical device industries
  • FDA enforcement trends for current Good Manufacturing Practice (cGMP) for Food, Drugs, Biologics, and Medical Devices
  • Perspectives on changes in regulatory environment
  • PASS-IT recommendations: dos and don’ts

Who Should Attend

  • CEOs and VPs
  • Compliance Officers
  • Attorneys
  • Regulatory affairs staff
  • Clinical affairs staff
  • Quality assurance staff
  • R&D staff
  • Consultants
  • Contractors/subcontractors
  • Anyone interested in the 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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