PHARMA SUPPLY CHAIN,FDA EXPECTATIONS,(FDA/EMA/MHRA 2012 - Live webinar on FDA Compliant Good Laboratory Practice (GLP) For Drugs, Biologics, Biosimilars and Medical Devices By Compliance2go

Why should you Attend :

If you don’t know the answers to the following questions, you should attend the webinar:

? What is Good Laboratory Practice (GLP)?
? What are the federal statutes and regulations governing GLP?
? What are the GLP requirements applicable for drugs, biologics, biosimilars and medical devices?
? What studies are subject to GLP?
? What are the requirements for the sponsor?
? What are the requirements for study directors and QAU?

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

This webinar is intended to help you get familiar with the relevant and applicable US regulations, regulatory requirements and guidance necessary for good laboratory practice (GLP) and GLP compliance. This webinar is further intended to provide guidance on GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products including, but not limited to, biologics, human drugs, biosimilars and medical devices for human use regulated by the United States Food and Drug Administration (US FDA).

The US FDA regulates scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices including biosimilars. Those who conduct preclinical studies that support or are intended to support applications for research or marketing permits for products (e.g., biologics, drugs, biosimilars and medical devices) are subject to compliance with the relevant and applicable statutes and GLP regulations. Compliance with the GLP regulations is intended to assure the quality and integrity of the safety data filed pursuant to the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) and the Public Health Service Act (PHS Act).

Understanding GLP regulations and requirement and achieving GLP compliance can significantly contribute to expediting the regulatory processes, bringing innovative medical products to the market faster.

This webinar will discuss GLP regulations, requirements and compliance including how to prepare for GLP inspection. At the end of the webinar, you will get familiarized with the applicable FDA GLP regulations, requirements and how to achieve GLP compliance.

Areas Covered in the Session:

? Overview and review of US FDA GLP regulations and requirements
? Good laboratory practices: scope, objectives and definitions
? Organization and personnel: personnel, management, study director and quality assurance unit
? Facilities and equipment
? Testing facilities operation: standard operating procedures (SOPs)
? Test and control articles
? Protocol and conduct of a GLP study
? Records and reports
? GLP compliance and inspection
? Eight (8) case studies for enforcement actions
Lessons learned.

Who will benefit: (Titles)

? R&D Scientists, Engineers, Managers, Directors, and VPs
? Regulatory Affairs Managers, Directors and VPs
? Quality Engineers, Managers,Directors, and VPs
? Compliance Officers and Legal Counsel
? Clinical Affairs Personnel (Coordinators, Monitors, Managers, Directors, and VPs)
? Complaint Handling and Risk Management Managers and Directors
? Clinical investigators and CRO employees
? Consultants
? Senior and Executive Management
Anyone involved in the clinical trials or studies

About Speaker

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, he has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (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, Regulatory Doctor, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. 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. Dr. Lim has analyzed over 1,000 FDA warning letters, 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 devices, 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). He is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs.