This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with it. Get practical recommendations from industry leading expert Dr. Ludwig Huber.
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 seminar 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 archive GLP data, 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 Seminar:
- 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.
- Data generation and evaluation: raw data, intermediate results, final results.
- Records keeping: format, length of time, archiving and reprocessing.
- Preparing for FDA inspections.
Who Will Benifit:
- Lab Supervisors and Managers
- GLP auditors
- GLP study directors
- IT managers and personnel
For More Information: