Understanding the Modern Good Manufacturing Practices (GMP)

Description

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

Why Should you Attend

The guidelines  GUI-001 s interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada. Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (the Act) and associated regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements.

Who Should Attend

• Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals who need a fundamental understanding of the GMPs related to pharmaceutical operations
• All levels of management who require a refresher course to stay current with GMP regulations and brush up on relevant skills
• Service organizations, suppliers, and vendors who serve pharmaceutical industry clients

Learning Objectives

• Explain Health Canada, U.S. and European regulatory requirements and the origin and status, and describe how USFDA, EMEA and European directives fit into the regulatory picture
• Discuss the hierarchy of laws, directives, regulations, guidelines, and guidance documents
• Apply a fundamental knowledge of GMPs related to pharmaceutical industry operations
• Demonstrate a better understanding of how regulatory authorities review the production of pharmaceutical products
• Recognize GMP problem areas before they create issues
• Identify the key control areas associated with pharmaceutical operations that are required for compliance: technical (buildings, equipment, and materials); operational (policies, procedures, and records); and relational (employees, suppliers, and customers)
• Find current information regarding regulatory authority activities
• Principles of Data Integrity and Good Documentation Practices
• Apply GMP guides to Digital Transformation in Biomanufacturing
• Prepare for a regulatory inspection and learn best practices on how to handle an inspection

Education approach

• Lecture sessions are illustrated with examples based on case studies
• Practical exercises include examples and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer