GLP Quality System Essences and Comparison with GMP 2017 is a webinar that covers topics such as:
- 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
GLP Quality System Essences and Comparison with GMP 2017 is intended for:
- Laboratory Managers
- Study Directors
- Quality Control Staff
- R&D Researchers of Pharmaceutical and Veterinary Companies
- Regulatory Affairs (RA) Staff