This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with them. Get practical recommendations from industry leading expert Dr. Ludwig Huber.
Complimentary Hand-outs:
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.
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
Course Content
- 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
Speaker
Dr. Ludwig HuberCourse Provider
Dr. Ludwig Huber,
