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Dr. David Lim
Ph.D., RAC, ASQ-CQA
Senior Vice President, Scientific and Regulatory Affairs |
Aquavit Pharmaceuticals, Inc., New York
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| Profile |
Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia in 1993. Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the Transparency Public Meeting organized by the FDA. Recently, Dr. Lim founded a consulting firm (www.RegulatoryDoctor.com) providing all aspects of regulatory, quality and compliance matters. Currently, Dr. Lim is Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim has completed two years in law school and will pursue his last year in law school. Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs.
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| FDA BIMO Inspection: Do's and Don'ts |
| Live Corporate Webcast |
Friday – 24th February – 2012 – 2:00 PM EST | 11:AM PST
Duration of webcast : 1 hour | Duration of Q/A session : 10-15 mins
Post Session : Copy of Presentation Slides will be shared
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Short
Abstract: |
This webinar is intended to provide EQ + practical and actionable guidance on how to proactively prepare for a sustainable FDA BIMO inspection and the proper response, if necessary, during and after the inspection including Do’s and Don’ts.
The United States Food and Drug Administration (FDA) regulates scientific studies, which are designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices including in vitro diagnostic devices. Those who are involved in carrying out preclinical studies and clinical studies must comply with the relevant and applicable statutes and regulations, which cover GLP and GCP. This webinar will discuss GLP and GCP in a way to efficiently and effectively help you prepare for an FDA Bioresearch Monitoring (BIMO) inspection. By dissecting the recent ten (10) case studies, you will increase awareness and familiarity for the causes of inspectional deficiencies. You will also be presented with practical and actionable solutions for the same or similar deficiencies. At the end of the webinar, you will get empowered in an effective way that you would plan, develop and execute differently.
The presentation will cover the following areas:
- FDA regulations and guidance on GLP and GCP
- GLP requirements
- GCP requirements
- BIMO program
- BIMO inspection
- How to communicate during and after BIMO inspection
- Clinical investigators (CI)
- Institutional review boards (IRBs)
- Sponsors
- Monitors
- Contract research organizations (CROs)
- ICH-GCP guidelines
- ISO 14155
- Ten (10) case studies
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| Participants: |
CSOs, VPs, Directors, Heads, Managers working within:
- Regulatory Affairs Professionals (Associates, Specialists, Managers and Directors)
- Compliance Specialists and Officers
- Regulatory and Legal Counsel
- Quality Professionals (Associates, Specialists, Engineers, Managers and Directors).
- Research and Development (R&D) Managers and Directors
- Product and Development (P&D) Managers and Directors
- Complaint Handling and Risk Management Professionals
- Sales and Marketing Professionals
- Clinical Affairs Managers and Directors
- Site Managers, and Consultants
- Senior and Executive Management
- Anyone Interested in Learning More About US FDA Regulations
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| Pay and Get Registered |
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- This webinar will discuss GLP and GCP including the relevant and applicable FDA regulations and guidance.
- Registration Fee : USD $299
- For assistance on registration, please send an email to marketing@biopractice.com or
- Please call: Ph - 1-646-216-8860
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Best Regards.
Marketing.
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