Good Manufacturing Practices (GMPs) and Good Laboratory Practice (GLP) are fundamental for successful pharmaceutical and laboratory operations. The GMP/GLP course is designed to help participants better understand the regulations and expectations of Health Canada HPFBI and US FDA GMP/GLP Guidelines and how these regulations apply to the manufacturing, distribution and importation of pharmaceutical, radiopharmaceutical, biological, and veterinary drugs. As well, participants will gain essential skills on effective SOP writing and GMP auditing. Participants will also receive valuable insight from guest speakers who work within the pharmaceutical industry.
Participants will gain knowledge of the principles of GMP/GLP and their practical application through the following topics:
• Introduction to GMP and GLP
• Premises and Equipment
• Personnel and Sanitation
• Raw Material Testing
• Manufacturing Control
• Quality Control Department
• Good Laboratory Practice
• Packaging Material Testing and Finished Product Testing
• Records and SOP Writing
• Reserve Samples and Stability
• Sterile Products
• GMP Auditing
• Gain the skills and knowledge necessary to understand and work in a GMP/GLP compliant environment
• Understand the purpose and reasoning of GMP/GLP Regulations and their practical application through key quality systems
• Understand the QA-GMP-QC relationship
• Enable participants to appreciate the individual GMP responsibilities, quality management responsibilities, and know the consequences of failure to comply with the GMP/GLP Regulations
• Learn essential skills for effective SOP writing and GMP auditing
• Understand the importance of good documentation practices and record keeping
• Build networks with peers and professionals within the industry
