- Date: October 10, 2016
- NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays.
- Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
- Time: 12:00 PM PST | 03:00 PM EST
- Duration: 60 Minutes
About the Seminar
This seminar is intended to discuss FDA inspection practices and the most common deficiencies for drug and medical device manufacturers including in vitro diagnostic device (IVD) manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past eight (8) years.
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 practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.
The speaker will share his PASS-IT recommendation/suggestions.
About the Areas to Be Discussed
- Applicable Laws and Regulation
- FDA Manuals and Inspection Guides
- Hosting an FDA Inspection
- Inspection Types and Categories
- Inspection Classification
- FDA Forms 482 and 483
- Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
- How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
- What/How to Prepare for and Manage an FDA Inspection
- How to Communicate Before, During and After inspection: Dos and Don’ts
- Common Mistakes and How to Prevent Them
- How to Most Effectively Use Close Out Meeting
- Responding to 483s, If Issued
- Importance of Communication with EQ
- Affidavits and Employee Training
- Actual FDA Inspection Case Studies (Reports)
- Speaker’s PASS-IT Suggestions/Recommendations
About the Intended Attendee(s)
- Regulatory Affairs
- Clinical Affairs
- Senior Management
- Compliance Officers
- Anyone Interested in the FDA Inspection
About the Seminar Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
- Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
- Option 2: you may request an invoice by email to Global Compliance Seminar
- Option 3: you may purchase online below using a credit card or PayPal.
LIVE (one attendee): $299
LIVE (≤ 5 attendees): $699
LIVE (≥ 6 attendees): $999
LIVE & Recorded: $399
INVESTIGATIONS OPERATIONS MANUAL 2016 in PDF (107 Pages)