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.
People working in GMP including
Handy Consulting Ltd
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
09:30 Introductions and Scope of the Course
Understand the group requirements and the tutor’s background & experience
09:45 Background & Regulatory Environment
Setting the scene, understanding the context, key legislation
10:30 Principles of GMP
Key points and requirements
11:15 Personnel & Responsibilities
Management and staff, duties and accountabilities
11:45 Overview of GMP Manufacturing
Basics of the product life cycle
13:15 Risk Management Workshop
Practical exploration of risk and mitigation activities
14:30 QC Laboratories
Activities and Practicalities
15:30 Compliance Quality Assurance and Self Inspection
16:00 Question Time
A chance for questions on the practicalities of GMP
16:30 Close of course