GLP Regulations – Introduction and Strategies for Implementation

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, or 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. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.

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

Areas Covered in the Session :

• FDA and International GLP regulations: 21 CFR Part 58, OECD
• Examples for FDA 483 inspectional observations and warning letters
• Objectives, scope 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
• Data generation and evaluation: raw data, intermediate results, final results
• Records keeping: format, length of time, archiving and reprocessing
• Strategies for Multi-site GLP Studies
• Preparing for FDA inspections

Who Should Attend:

A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Contract manufacturing organizations, Clinical research organizations. The teams that will benefit the most are:

• Lab Supervisors and Managers
• QA Managers and Personnel
• GLP Auditors
• GLP Study Directors
• Analysts
• Consultants
• Teachers
• Everybody getting involved in GLP studies

Course Director: DR. LUDWIG HUBER

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, 21CFR Part 111 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. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).