Implementing the Best Practices for FDA Inspection Preparation and Management
- Speaker:Dr. David Lim
- Date: 28th August 2018 10:00 AM PST | 01:00 PM EST
- Product Code:GRC-90367
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Live Session - How it works
- Username and Password will be sent to you within 24 hours prior to the webinar.
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Recorded Session - How it works
- Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
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Training CD - How it works
- Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
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GRCTS Attendance Certificate
This seminar will discuss guidelines to adequately implement the best practices for FDA inspection preparation and management compliant with the Good Manufacturing Practices (GMPs) regulations. The common GMP deficiencies cited in 483s issued to medical device and pharmaceutical manufacturers 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 improve awareness and insight on practical, actionable, and sustainable approaches including do’s and don’ts when preparing for and managing FDA inspection matters in an informed, proactive manner.
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 common deficiencies observed during the FDA inspections of firms (medical device and pharmaceutical industries) for the past eight years.
The speaker will share his PASS-IT recommendation/suggestions.
- Applicable Laws and Regulations
- FDA Inspection Manuals and Inspection Guides
- Inspection Types, Categories and Classification
- Common Deficiencies
- 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
- Recent Trends
- Responding to 483s, If Issued
- How to Communicate with Emotional Intelligence
- Employee Training
- Actual Enforcement 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. 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.