This programme is designed for experienced industry professionals who require current best practices in order to keep up-to-date with industry standards related to Good Laboratory Practices (GLPs) and its regulations. There are many professionals who have to comply with GLP regulations and most often they are involved in laboratory testing of drug, food, biological or chemical products: Understanding and applying the principles of Good Laboratory Practices is helpful in performing laboratory studies. This programme helps participants apply GLP regulations and responsibilities to ensure accuracy and reliability of the results, which has been generated and accumulated through laboratory studies.
Dwarka Sector-7, New Delhi-110075
Pharmaceutical Good Laboratory Practice
On successful completion
On successful completion of this programme, participants are expected to have better understanding of the requirements of GLP for the efficient working of a testing laboratory by applying the knowledge into practice. The programme provides an overview of ISO / IEC 17025: 2005 as well as the common requirements of GLP Compliance (OECD & FDA) as applicable to various testing Laboratories and research organizations. This will also include recent developments related to computer validation.
Programme Modules
Module 1: Introduction, fundamentals and principles of GLP
Module 2: Documentation, records and preparation of SOPs
Module3:GLP compliance & preparation for certification; ISO / IEC 17025: 2005 & Laboratory accreditation
Module 4:Internal Quality Audits for various Quality Management Sytems (QMS)
Module 5: Use of Computers in the laboratory
Module 6: General Good Testing Conduct
Module 7: International GLP of the OECD, FDA etc
Module 8: Management, Personnel, Buildings & Equipment
Module 9: Method Validation and Quality Assurance
Module 10: Inspection of a testing facility
Module 11: Demonstration of Instrument Handling used in Pharmaceutical Laboratory
Module 12: Case studies