GCP/GLP/GMP: Comparative Overview and Understanding of FDA’s 3 Major Regulations

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Thu, Aug 04, 2016
60 minutes
Product Description

Get a Better Understanding of GLP, GCP and cGMP Requirements

It is important for the pharmaceutical, biologics and medical device industries to accurately understand the requirements under Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).

This session by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will help industry professionals get a better understanding of GLP, GCP and cGMP requirements from a practical perspective and meet the FDA expectation for compliance. This presentation will provide you an opportunity to learn about FDA’s current views and perspectives on technical challenges, considerations and assessment of 3D medical products.

Session Highlights:

  • Laws and Regulations
  • Definitions
  • Regulation and Requirements for Good Laboratory Practice
  • Regulation and Requirements for Good Clinical Practice
  • Regulations for Current Good Manufacturing Practice for Food, Drugs, Biologics and Medical Devices
  • FDA Guidance and Standards
  • Best Practices: Dos and Don’ts

Who Should Attend

  • Global medical device and in-vitro diagnostic device industry
  • Global pharmaceutical and biologics industry
  • Research laboratories
  • Healthcare industry management
  • Healthcare industry professionals

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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