What FDA-Regulated Industry Should Know about FDA’s New Policy on GMP Enforcement

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.

Areas Covered in the Session :

• Identifying and understanding important factors when establishing good manufacturing practices for medical devices
• Identifying and understanding critical factors to consider for design control
• Recognizing, understanding, and avoiding 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

Course Director: DR. DAVID LIM

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.