GLP Quality System Essences and Comparison with GMP 2017

Topics

• GLP, GMP and ISO 17025
• Brief Introduction
• Principals
• OECD GLP
• Quality Assurance Program
• Test Facility Organization and Personnel
• Apparatus, Material, and Reagents
• Facilities
• Test and Reference Items
• Test Systems
• Performance of the Study
• Standard Operating Procedures
• Storage and Retention of Records and Materials
• Reporting of Study Results
• The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP
• The Role and Responsibilities of the Study Director in GLP Studies
• FDA GLP
• Terms/Vocabulary
• EPA GLP
• 21CFR 58
• Comparison between GLP and GMP
• 40CFR160 & 40CFR792

Who should Attend

• Laboratory Managers
• Study Directors
• Quality Control Staff
• R&D Researchers of Pharmaceutical and Veterinary Companies
• Regulatory Affairs (RA) Staff