Quality Assurance and GMP Certificate
AAPS’ Quality Assurance and GMP program highlights the Canadian and international requirements of quality assurance, quality control, compliance and GMPs as they apply to the regulated pharma, biopharma, medical device, cosmetics, and food industries.
Students will gain working knowledge of how QA/QC principles apply to the Pharma and Food Industry, and how to apply industry specific concepts to food safety management systems. This knowledge can also be applied to several similar industries that deal with quality and compliance requirements.
GMP- Introduction: This course focuses on the history and purpose of GMP requirements as they apply to the manufacturing, packaging and labeling, testing, and control of pharmaceutical products.
GMP- Intermediate: This course uses case studies and student workshops to teach the fundamentals of designing and developing a strong and compliant quality system. Students will learn about quality management tools such as change management, failure investigation, laboratory control systems, validation systems, and more.
GMP- Advanced: This course examines the more advanced aspects of global GMP and other international regulatory guidelines, and policies. Students will learn about international regulatory standards and guidelines such as ISO 9000 series, SUPAC, ICH, MRA, and the latest FDA requirements.
Auditing – Introduction: This course combines theory with hands-on training to provide students with a solid understanding of how in-depth audits of quality systems in the pharmaceutical industry are carried out.
Auditing – Advanced: This course focuses on the four main components of the quality system: management controls, design controls, production and process controls, and corrective and preventive actions, in order to give students the skills they need to perform quality inspections.
Technical Writing and Scientific Communication: This course covers the main elements of developing important documents such as Standard Operating Procedures (SOP), Records of Training, Batch documents, and more.