Keeping up with the changing legislation for clinical trials provides challenges for all those working with investigational medicinal products. This highly interactive training course teaches you all you need to know about international GMP regulations and requirements for the manufacture, control, storage and distribution of medicines to be used in clinical trials manufacture.
Using practical exercises, our clinical trial GMP training tutors help you to gain a better understanding of the ever-changing world of clinical supply and its legislation. Our tutors are a combination of ex MHRA inspectors and current IMP QPs, and teach you simple and pragmatic ways of working designed to help you better meet the needs of the regulators.
This training will be delivered as a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
This course is approved by the Royal Society of Chemistry and is suitable for its members’ continuing professional development.
On completion of this course, delegates will know and understand:
A significant portion of course time is devoted to group work. Using case studies, delegates have the opportunity to put theory into practice. In addition, discussion periods (which include a course tutor panel session) provide delegates with an opportunity to obtain answers to their specific question and concerns.
Darren Jones – Darren is an ex-MHRA GMP Inspector and has audited dosage forms for both commercial and clinical trial applications. Darren also has a wealth of practical knowledge and experience applying GMP in the clinical development world gained during his 18 years with AstraZeneca, prior to joining the MHRA. He was a Qualified Person for IMPs and knows the real challenges and how to overcome them.
Richard Funnell – Richard spent 11 years with the MHRA, including seven as a Senior GMP Inspector with the lead for IMPs. Richard has current knowledge and understanding of what inspectors are looking for in the lead up to the new clinical trial regulations.
Kate Krachai – Kate has over 20 years’ experience in the pharmaceutical industry as a proactive quality manager and pharmaceutical lead auditor, working to enrich quality systems and compliance with companies of varying sizes globally.
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Learn the essential elements of an effective, compliant, modern pharmaceutical quality system.
Gain knowledge and understanding of international pharmaceutical legislation so you can carry out your duties with skill and authority.
NSF’s Royal Society of Chemistry-approved QP course is designed for aspiring QPs and other pharmaceutical quality professionals.