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CPD Hours: 14
Classroom, online, in-house, eLearning
All QPs need to understand the different Good Manufacturing Practice (GMP) requirements for commercial and Investigational Medicinal Products (IMPs), and the unique additional GMP requirements for IMPs. This two day interactive course examines the EU legislation relevant to the manufacture, control and supply of IMPs. It provides practical guidance on the major differences in the GMP requirements between IMPs and commercial products, and the unique areas that QPs need to consider when releasing IMPs e.g. packaging and labelling processes and control.Delegates will also benefit from the opportunity to learn about the principles of Good Clinical and Good Laboratory Practice, and how these relate to GMP for IMPs.
This course now has an optional eLearning Knowledge Reinforcement Module available for delegates to purchase at £170. The eLearning module reviews 5 key topics from the tutor led course and has 72 questions, to test your knowledge and ensure you know the subject matter ready for your Viva.
The course is ideally suited for those wishing to ensure they have sufficient awareness of the specific nature of IMPs and the challenges facing the QP, and is suitable for QPs, Production and QA Staff working in IMP manufacture and supply.
At the end of the course you will:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.
Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.
Good clinical practice for ATMPs
Provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP) specific to ATMPs.