GLP Regulations – Introduction and Strategies for 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 Will Benefit:

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