How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

Why Should You Attend:

To be able to achieve sustainability and to remain sustainable and competitive in global medical product markets, it is necessary to streamline regulatory compliance processes, in particular, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP, it is critical to accurately define, document and implement “current, accurate, and complete” (CAC) requirements pursuant to the relevant and applicable laws and regulations, GCP requirements, and compliance in a systematic, integrative (SI) manner.

This webinar is intended to help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner, all of which are regulated by the United States Food and Drug Administration (FDA). At the end of this webinar, you will leave empowered with the knowledge of applicable FDA regulations and requirements.

Areas Covered in the Seminar:

• Current, accurate, and complete (CAC) review of FDA regulations including INDs and IDEs.
• Systematic and integrative (SI) analysis of regulations and law governing clinical trials and studies, requirements, and compliance.
• General information for clinical studies.
• Clinical investigators (CI).
• Institutional review boards (IRBs).
• Sponsors.
• Monitors.
• Contract research organizations (CROs).
• ICH-GCP guidelines.
• ISO 14155.
• Enforcement actions (case studies).

Who will Benefit:

This webinar will be valuable for anyone in global medical industry including, but not limited to, those working on drugs, biologics, medical devices, and in vitro diagnostic devices who are involved in the processes of clinical trials and studies, adverse event reporting, complaint handling and regulatory compliance. By understanding Good Clinical Practice (GCP) for the clinical trials and studies in a systematic, integrative manner, the process owners can better establish and maintain the compliant processes, improving patient rights, safety, wellfare and further achieving regulatory compliance.

The following employees who will benefit include:

• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
• Complaint handling personnel
• Regulatory affairs (associates, specialists, managers, and directors)
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
• Research and development (associates, scientists, managers, directors and VPs)
• Product and development (associates, scientists, managers, directors and VPs)
• Marketing (associates, specialists, managers, directors and VPs)
• Site managers, and consultants.
• Contract manufacturing organization (associates, scientists, managers, directors and VPs)
• Contract research organization (associates, scientists, managers, directors and VPs)
• Senior and executive management (VPs, SVPs, Presidents and CEOs)
• Contractors and subcontractors

Instructor Profile:

Dr. David 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, 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 FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as 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, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). 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 is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.

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