About the Webinar
The Introduction to OECD (Organization for Economic Cooperation and Development) GLP Principles session is primarily intended to provide an overview of the guidelines for non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. Additionally, the session will cover Data Integrity and GLP for in vitro studies.
Kamaljit (Kam) Singh:
Kamaljit is the president of GxP Consulting Corp., a Toronto based company that advises pharmaceutical/medical cannabis and contract research companies (GLP and GCP) on implementing and managing quality management systems.
Kamaljit has over 28 years of combined experience in the Cannabis Industry, Pharmaceutical Manufacturing, Natural Health Products, Biotech, Non-Clinical and Clinical Research sectors, with expertise in FDA-USA and Health Canada GMP audits. Kamaljit has vast knowledge and experience pertaining to pharmaceutical compliance, regulatory affairs, GMP practices, and overall Quality Assurance/Quality Control (QA/QC) programs. He held a variety of QA/QC positions with global companies like Certara, Zenabis Global (now Hexo Corp.) Ranbaxy Laboratories, MDS Pharma Services, Pharma Medica Research, Variation Biotechnologies and Purdue Pharma.
Scope of presentation
· What is GLP?
· History of GLP
· What are the different elements of GLP?
· Test Facility Management (TFM)
· Study Director / Principal Investigator
· Quality Assurance Programme (QAP)
· Study Personnel and the Archivist
· Test System Facilities
· GLP requirements for Apparatus
· Materials, Reagents and Solutions
· Test System
· Study Plan and Study Conduct
· SOPs, Deviations and Note to Files
· Raw data and Data Integrity
· Single and Multi-Site Studies
· QA and QC of Study reports
· Final Report
· Records and Sample Retention
· Conclusion
· Q & A
22 авг 2022
