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Dr. David Lim
Ph.D., RAC, ASQ-CQA
Chairman & CEO |
www.RegulatoryDoctor.com
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| Profile |
Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), he was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein he provided inspiring and actionable solutions for sustainable business operation. Dr. Lim, Regulatory Doctor, provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). He 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 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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| Medical Device Regulations in EU and CE-Marking |
| Live Corporate Webcast |
Friday – 15th June – 2012 – 2:00 PM EDT | 11:AM PDT
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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Pay & Get Registered
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Short
Abstract: |
This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.
Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster.
This webinar will discuss EU Directives, requirements and compliance. At the end of the webinar, you will get familiarized with the applicable EU Directives governing medical devices including in vitro diagnostic and active implantable medical devices.
The presentation will cover the following areas:
- How EU laws are made
- Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices
- Medical Device Directive (MDD)
- Active Implantable Medical Device Directive (AIMDD)
- In Vitro Diagnostic Device Directive (IVDD)
- 2007/47/EC amending MDD and AIMDD
- CE marking principles
- ISO 13485, ISO 14155, and ISO 14971
- GHTF and MEDDEV guidance documents
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| Participants: |
CEOs, VPs, Directors, Heads, Managers working within:
- Medical Device (associates, specialists, managers, directors or VPs)
- Compliance Specialists and Officers
- Regulatory affairs (associates, specialists, managers, directors or VPs)
- Legal Counsel/Attorneys
- Quality Professionals (Associates, Specialists, Engineers, Managers and Directors).
- Research and Development (R&D) (engineers, scientists, managers, directors or VPs)
- Product and Development (P&D) Managers and Directors
- CROs
- Consultants, Contractors/Subcontractors
- 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 focus on Medical Device Regulation.
- 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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