Good Laboratory Practice Regulations: Introduction and Strategies for Implementation 2011
22 Sep 2011
Webinar
Key Topics
Examples for FDA 483 inspectional observations and warning letters
FDA and International GLP regulations: 21 CFR Part 58, OECD
Special organizational requirements
Objectives and concepts of GLP`s
SOP requirements: type, formats and enforcement
Responsibilities: Management, Study director, QA, analysts
Key requirements for equipment, facilities reference material, people
GLP studies: preparation, conduct, documentation
Records keeping: format, length of time, archiving and reprocessing
Data generation and evaluation: raw data, intermediate results, final results
Preparing for FDA inspections
Strategies for Multi-site GLP Studies
Who should Attend
QA managers and personnel, Lab Supervisors and Managers, Analysts, GLP auditors, Consultants, IT managers and personnel and Teachers.
Past Events
Good Laboratory Practice Regulations: Introduction and Strategies for Implementation 2011 - 22 Sep 2011, Webinar (18853)
Good Laboratory Practice Regulations: Introduction and Strategies for Implementation 2026
Important
Please, check "Good Laboratory Practice Regulations: Introduction and Strategies for Implementation" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical laboratories, Pharma
