Keeping Up-To-Date as a (GMP) Qualified Person

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-house Training and Consultancy Services

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!

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme

Welcome and introductions

  • Objectives of the day
  • Format of the day

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

  • QP in a corporate environment
  • Role of QP working with outsourcing companies
  • Contract/Locum QP
  • Effective management of deviations and subsequent CAPAs

Refreshments (to be taken during the Workshop Sessions)

  • Appropriate use of quality risk management as a tool to assist sound decision-making
  • Handling complaints and potential recalls

Final discussions, Q&A and take home messages

Recommended trainer

Sue Mann

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.

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

Previous customers include...

  • Annette Callaghan Ltd
  • Aspar Pharmaceuticals Ltd
  • Bayer Healthcare
  • Besins Healthcare
  • Bespak UK
  • CANCER RESEARCH UK
  • Christine Morris Quality Consultancy Ltd
  • CP PHARMACEUTICALS LTD
  • Delorbis Pharmaceuticals Ltd
  • Ernest Jackson & Co Ltd
  • Fresenius Kabi Oncology Plc
  • GlaxoSmithKline
  • Interport Ltd
  • Ipsen Biopharm Ltd
  • Merck KGaA
  • Natures Aid Health Products
  • PPD
  • Pronova Biopharma Norge A/s
  • QualiPharm Consultancy Ltd
  • Quality Professional Pharma Services Ltd
  • Quintiles Drug Research Unit at Guy's Hospital
  • Rottapharm Limited
  • Sanofi-Aventis
  • Smith & Nephew Wound Management
  • South Devon Healthcare NHS Trust
  • Takeda Development Centre Europe Ltd
  • Teva UK Ltd
  • Torbay Pharmacy Manufacturing Unit
  • Vitale-XD Ltd
  • Wrafton Laboratories Ltd, t/a Perrigo