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 Good Manufacturing Practice (GMP) with regulatory inspection in mind. Common regulatory findings.
People working in GMP including
Handy Consulting Ltd (Course Principal)
"Very good and engaging presenters."
|9.30||Introductions and Scope of the Course
Understand the group requirements and the tutor's background and experience.
|9.45||Background and Regulatory Environment
Setting the scene, understanding the context, key legislation.
|10.30||Principles of GMP
Key points and requirements.
|11.15||Personnel and 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.
Activities and practicalities.
Quality Assurance and Self Inspection.
A chance for questions on the practicalities of GMP.
|16.30||Close of course|
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
You will need a stable internet connection, a microphone and a webcam.