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
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
Agenda
- 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
