This intensive course is designed for engineers in the pharmaceutical industry, focusing on the critical aspects of quality assurance, quality control, and regulatory compliance. It covers the intricate details of pharmaceutical manufacturing standards in Canada and the United States, highlighting the importance of quality management systems, active and non-active ingredients, filler ingredients, and the nuances of Canadian and American pharmaceutical standards. Participants will gain in-depth knowledge about Health Canada and FDA regulations, process validation, data management, risk management, and the complexities of pharmaceutical documentation and audit readiness.
Key Topics Discussed:
- Quality Assurance and Control in Pharmaceutical Manufacturing: Understanding the fundamental concepts and importance of quality assurance and control in the pharmaceutical sector.
- Regulatory Compliance: Navigating and complying with Health Canada and FDA standards, focusing on differences and similarities between Canadian and American pharmaceutical regulations.
- Quality Management Systems (QMS): Detailed study of QMS and their role in ensuring quality in pharmaceutical practices.
- Active Pharmaceutical Ingredients (APIs) and Fillers: Challenges and regulations associated with APIs, fillers, and other pharmaceutical ingredients.
- Instrument Quality and Process Qualification: Ensuring quality and reliability in manufacturing processes and equipment.
- Data Management and Integrity: Strategies for managing pharmaceutical process data, ensuring its accuracy and integrity.
- Risk Management Methodologies: Applying methodologies like FMEA and HAZOP in quality assurance.
- Preparation for Regulatory Audits and Inspections: Best practices and strategies for handling audits and inspections by regulatory bodies.