An *In-house* GMP QPs programme providing up-to-date and detailed guidance for current, trainee and returning QPs, to help them fulfil their duties effectively and efficiently in the pharmaceutical Industry.
In this highly competitive industry, the role of the Qualified Person (QP) has come under intense focus and scrutiny. It is no longer enough to “just” satisfy the well documented legal and professional duties; QPs need to also be seen as part of the business and k=key to the company’s success. QPs need to be proactive, help the organisation plan for an deal with emerging situations and new challenges. Equally, when something goes wrong, the QP needs to be seen as part of the solution whilst ensuring patient safety is protected at all times.
QPs therefore need to not only keep up-to-date with new and proposed changes to legislation and guidelines, they need to develop strategies to enable them to effectively deal with all types of situations – often with tight timelines. This In-house course has been developed specifically to answer these questions and help QPs improve their effectiveness and efficiency. The workshops will allow participants to discuss best practice – and maybe also share some things that didn’t work well!
Welcome and introductions
Latest updates on legislation and guidelines relevant to the QP (Commercial and IMP)
Discussion on challenges associated with these changes
Updates on latest developments relating to the Falsified Medicines Directive (FMD)
Impact on the role and duties of a QP as a Result of Annex 16 Changes
Discussion on the challenges and recent experiences complying with the New Annex 16
Workshops: Dealing With some of the more difficult areas as a QP
Refreshments (to be taken during the Workshop Sessions)
Final discussions, Q&A and take home messages
Sue has extensive experience in the Pharmaceutical Industry, spanning over 30 years, principally in Quality Assurance, and also in Clinical Trials supply, Technical Management and production support. She has worked for many types of companies, including multinational, national, CMO, Japanese and virtual; latterly as Vice President of International Quality Assurance at Shire Pharmaceuticals. She was responsible for all quality, GMP and related aspects for both development and marketed products. Sue has also spent over 14 years in total as a QA/GMP consultant, providing Quality System support, Quality, GMP and technical training, Regulatory inspection support and auditing around the world. She is now Managing Director of Sue Mann Consultancy Ltd. She has knowledge and experience of all the major dosage forms, both in R&D and commercial operations. Sue is a Pharmacist, a Qualified Person, member of the Chartered Quality Institute and the Research Quality Association (RQA). She is also a QP Assessor, working on behalf of the UK MHRA, representing the Royal Pharmaceutical Society.
We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements: