This seminar is intended to discuss what FDA-regulated industry should know about FDA’s inspection policy to better implement the best Good Manufacturing Practices (GMPs). The common deficiencies found based on 483s issued to medical device and pharmaceutical industries will be discussed. The most common deficiencies are based on the speaker’s analysis of 483s issued for the past eight (8) years.
This presentation will greatly help you better prepare for and manage an FDA inspection in a proactive and effective manner.
The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.
This presentation will provide great opportunities to become familiar with the FDA inspection policy and industry’s best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.
Areas To Be Covered in this Seminar:
• Applicable Laws and Regulations
• FDA Manuals and Inspection Guides
• Hosting an FDA Inspection
• Inspection Types and Categories
• Inspection Classification
• FDA Forms 482 and 483
• Common deficiencies in 483s
• What/How to Prepare for and Manage an FDA Inspection
• How to Communicate Before, During and After inspection: Dos and Don’ts
• Inspection Preparation Procedures
• Close Out Meeting
• Responding to 483s, If Issued
• How to Communicate with Emotional Intelligence
• Employee Training
• Actual Case Studies
• Speaker’s PASS-IT Recommendations
Who will benefit:
• Compliance Officers
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• Anyone Interested in the FDA Drug Review and Approval Processes
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.
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