Good Laboratory Practice Regulations

Complimentary Hand-outs:

For easy implementation, attendees will receive

• Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• SOP: Archiving GLP Data and Other Documents

Why Should You Attend:

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment.

This online training will give a good understanding of GLP regulations and recommendations and tools for implementation. Attend this webinar to understand what is GLP, who has to comply, differentiations of US and International regulations on GLP, how to comply with 21 CFR Part11 to ensure data integrity, and how to archive GLP data and document GLP and protocols. Dr. Huber will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, checklists, templates and examples will help immediate and cost effective implementation.

Areas Covered in the Webinar:

• FDA and International GLP regulations: 21 CFR Part 58, OECD
• Objectives and concepts of GLP's
• Special organizational requirements
• Responsibilities: Management, Study director, QA, analysts
• SOP requirements: type, formats and enforcement
• GLP studies: preparation, conduct, documentation
• Key requirements for equipment, facilities reference material, people
• 21 CFR Part 11 compliant generation, evaluation and archiving of raw data, intermediate results, final results
• Records keeping: format, length of time, archiving and reprocessing
• Preparing for FDA inspections

Who Will Benefit:

• Lab Supervisors and Managers
• QA managers and personnel
• GLP auditors
• GLP study directors
• Analysts
• Consultants
• Teachers
• Pharmaceutical Research
• Pharmaceutical development
• Contract laboratories
• CROs

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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