Introduction to Good Manufacturing Practice

Course Information

This course is designed to provide comprehensive guidance and practical help for those working to implement Good Manufacturing Practice.

Scope

Basic requirements for a pharmaceutical quality system (PQS) and an understanding of quality risk management (QRM) principles and their application, from current regulations and guidance.
An introduction to the Site Master File, roles and responsibilities, change control, document control, and key documentation for implementing Good Manufacturing  Practice (GMP) with regulatory inspection in mind. Common regulatory findings.

Who should attend?

People working in GMP including

• R&D
• Contract Manufacturing Organisations
• Manufacturing
• Quality Assurance
• Auditing

Event Objectives: By the end of the course, delegates shall

• Have an awareness of the basic requirements of GMP
• Be aware of the EU GMP Rules and Guidance and relevant publications
• Understand the roles and responsibilities associated with GMP
• Be able to contribute to and maintain quality documentation
• Have a basic understanding of product lifecycle and manufacturing
• Understand the requirements of GMP in the QC laboratory context
• Have a basic understanding of risk management and mitigation principles
• Understand the need for quality systems and quality assurance activities
• Be aware of common regulatory findings

Learning Outcomes: Delegates will be able to

• Implement their role within GMP with confidence and knowledge of the principle requirements
• Contribute effectively to the GMP quality system and their organisation’s compliance
• Comprehend where their organisation’s activities sit within the larger GMP arena
• Know where to seek further information within the published rules and guidance, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet.