In FDA-regulated industries, it is imperative that firms should be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is important to recognize policy changes and risk-based, strategic regulatory and compliance approaches (best practices) under the new administration.
In this session, we will discuss FDA’s policy changes, risk-based regulatory and compliance approaches under new administration for 2018 and beyond. This session will help youbetter prepare for and manage risk-based FDA inspection preparation and management, in a proactive and effective manner. David will share his actionable tips and advice in view of recent FDA policy changes and enforcement actions. He will help you improve your awareness and knowledge of FDA enforcement and inspection policy and risk-based approaches under the new administration.
We will also discuss practical, actionable, and sustainable guidance on how to prepare for a risk-based FDA inspection and how to manage the FDA inspection process, including the dos and don’ts before, during, and after the inspection. With this session, you will become familiar with the lessons learnt from the FDA enforcement and inspection practices. David will also share his recommendations/suggestions for the dos and don’ts of PASS-IT.
Areas Covered in the Session :
- Laws and regulations
- New administration
- FDA policy
- FDA enforcement
- Risk-based approaches
- Industry misconceptions
- FDA inspection preparation and management
- Important awareness to improve
- Communication with the FDA
- Employee training
- Actual case studies
- Speaker’s PASS-IT suggestions/recommendations and dos and don’ts
Who Should Attend:
- Compliance officers
- Regulatory Affairs Departments
- Clinical Affairs Departments
- Quality Assurance Departments
- R&D Departments
- Anyone interested in the FDA regulatory pathways for new drugs and generics
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.