Implementing GMP for Medical Devices Compliant with FDA's New Inspection Policy and Trends

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Feb 06, 2019
60 minutes
Product Description

Confidently Comply with FDA's New Inspection Policy and Trends

There are many things the FDA-regulated industry—including medical device manufacturers and professionals—should know about the FDA’s current inspection policy to adequately implement the good manufacturing practices (GMPs). The consequences of failing to comply with FDA regulations can lead to such severe civil and criminal actions, that you simply can’t afford to take them lightly.

Learn the nuts and bolts of establishing GMPs for medical devices in this session by regulatory expert David Lim. Lim will discuss the critical factors you should consider when establishing design control. He will walk you through the common mistakes companies make, and show you how to avoid them. He will also be providing practical, actionable, sustainable solutions in an integrated, thorough manner (PASS-IT).

After attending this session, you will be better equipped to comply with FDA's new inspection policy and trends. You will know how to identify the important factors when implementing GMPs for your medical devices—including the critical factors for design control. Plus, you will be confident in your ability to avoid the common mistakes companies often make, thereby minimizing the risk of civil or criminal liability.

Session Highlights

You will learn how to:

  • Identify and understand important factors when establishing good manufacturing practices for medical devices
  • Identify and understand critical factors to consider for design control
  • Recognize, understand, and avoid common mistakes

Who Should Attend

  • R&D scientists, engineers, managers, and directors
  • Regulatory affairs professionals
  • Quality professionals
  • Product development professionals
  • Contract research organizations
  • Contract manufacturers
  • Consultants
  • Management representatives
  • Contractors and subcontractors

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
More Events By The Speaker

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