Event type:
1 day, professional development training course

Recommended for:

Auditors, scientists and managers

course programme and information

Course information:
This course is designed to provide comprehensive guidance and practical help for those working to implement Good Manufacturing Practice. 
  • 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 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
At the end of the course delegates will be able to:
  • Have an awareness of the basic requirements of GMP with a view to confidently hosting regulatory inspectors
  • Be able to find information within the EU GMP Rules and Guidance and relevant publications
  • Understand the structure and contents of the Site Master File, key roles, standard operating procedures, work instructions and batch manufacturing records
  • Have an understanding of PQS, QRM, change control and quality processes
  • Be able to align their GMP system with existing company certification
  • Be able to contribute to and maintain quality documentation
  • Be aware of common regulatory findings.

At the end of the course delegates shall:
  • Implement their role within GMP with confidence and knowledge of the principle requirements; know where to seek further information and clarification within the published rules and guidance, European Commission Directives, ICH Guidance and other relevant publications, as well as via the Internet.

Day 1
8:45 Registration
9:00 Welcome
9:15 Overview of the current regulations and source documents
PQS model and PDCA cycle
10:00 Basic requirements
 Review of GMP ‘Chapters’ by the group
10:45 Break
11:00 Importance of the Site Master File
Defining GMP policies
What you need to consider
11:40 QRM tools and techniques
12:00 Workshop 1: When and where to apply QRM tools and techniques
12:30 Lunch
13:15 Workshop feedback
13:30 Importance of organisation and structure
14:00 Documentation review and approval Responsibilities; types of controlled document
14:30 Workshop 2: Documentation exercise
Workshop feedback
15:00 Break
15:15 What does change control mean and when to apply it
15:45 Implementing GMP and planning for inspection – in summary                
Common regulatory findings
16:15 Questions and Answers
Open session followed with questionnaire (10 minutes) and course feedback (10 minutes)
16:45 Close of Course