Overview

This course provides an overview of Good Manufacturing Practices (GMP), including the principles and standards essential for ensuring quality, safety, and efficacy in industrial (bio)pharmaceutical processes. It offers a comprehensive approach to understanding and applying GMP, with particular emphasis on the implementation and monitoring of quality systems, the rigor of documentation, and the importance of investigation management. It is delivered through a combination of theoretical presentations, interactive exercises, and case studies.

Audience
Individuals aspiring to enter the biopharmaceutical/pharmaceutical industry in entry-level positions, as well as for those already in the industry who wish to deepen their knowledge of the principles of good manufacturing practices.

Key Topics
Principles of GMP, including quality and safety standards that govern the manufacture of high-quality products, ensuring traceability and compliance throughout the production process

• Quality management systems to control manufacturing processes, manage risks and ensure continuous improvement
• Good documentation practices to ensure accurate and compliant documentation to guarantee product traceability and conformity
•  Investigation processes, including the identification of a deviation or problem, root cause analysis, implementation of corrective/ preventive actions, and documentation to ensure compliance and avoid the recurrence of incidents

Learning Objectives

• Understand the key components of cGMP, including why they are so critical
• Identify the key building blocks of a pharmaceutical quality system, including its scope and roles and responsibilities of different departments/functions.Understand the importance of following best practices in deviation handling
• Understand the importance of following best practices in deviation handling

Delivery

• In English
• 1 day of practical training at the CASTL Biomanufacturing Training Facility in Montreal