This course is aimed at Managers, Supervisors, Technical Grades within Storage and Distribution Operations.

Overview

Based on the Cogent “Gold Standard” for the role of Responsible Person (RP) and the accompanying RP Training Standard, which is supported and recognised by the MHRA, this three-day course covers both the Rules and Regulations relating to Good Distribution Practice and the practical application of GDP in the workplace.

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In 2019, we were delighted to welcome Madeleine Ault, previously Senior GDP Inspector, MHRA, as a co-presenter of the RP Cogent Skills “Gold Standard” course. Madeleine brings many years’ regulatory experience with her.

Since May 2019, we have introduced an updated version of the course, focusing further on the challenges and opportunities offered to RPs. Even more exercises, workshops and case studies, using real-world examples, have been introduced. Delegates will also be encouraged to complete a pre-course exercise. Comprehensive course notes and a complimentary copy of the PQG GDP Monograph will be provided.

SeerPharma (UK) – our credentials:

  • Introduced RP and GDP training in 2005 – we believe we were the first to market in the UK
  • The only training provider to sit on the Expert Committee that developed the “Gold Standard”
  • Played a significant part in developing the Cogent Skills Training Standard for the role of the RP
  • Were the first to gain full accreditation for our RP course in September 2017, successfully re-accredited in 2018
  • Expert trainers, with a broad range of industry and regulatory experience
  • Practical, pragmatic approach to training, with exercises, workshops and case-studies.

Existing and prospective Responsible Persons, warehouse managers and supervisors, technical grades, distributors and carriers and anyone concerned with the regulatory aspects of pharmaceutical distribution will benefit from attending this course.

We offer public RP Gold Standard training through the year in either York or Buckinghamshire. We can also provide in-house courses.

Successful completion of the training course, which is recognised by the MHRA, is rewarded with certification from Cogent Skills that carries the MHRA logo.

Course Content

  1. Introduction & History of GXP
  2. The Quality System
  3. Personnel
  4. Premises & Equipment
  5. Documentation
  6. Operations
  7. Complaints, Returns, Recalls & Falsified Medicines
  8. Outsourced Activities
  9. Self-Inspections
  10. Transportation
  11. Brokers
  12. Assessment

Sessions

Dates Venue Early Bird Registration Closes
17th to 19th September 2019 De Vere Latimer Estate, Nr Chesham Course Full
15th to 17th October 2019 Park Inn Radisson Hotel, York 13th September 2019
10th to 12th December 2019
Park Inn Radisson Hotel, York 26th November 2019

If you would like further information on this course please call us on +44 (0)1903 730622 or e-mail  enquiries@seerpharma.co.uk

SeerPharma (UK) is proud to be a Cogent Skills Assured Provider.

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