NEW: Responsible Person course scheduled for 2019

Meets the Cogent Gold Standard

Our new Responsible Person course is now available with the first public course running in March 2019.

Uniquely we offer a 3-day course that we believe will confidently set budding RP’s on a path to becoming a Responsible Person in a much shorter timeframe than by attending other less in-depth and less interactive 2-day courses – see panel oposite for details.

The Responsible Person course includes all of the requirements of the Cogent Gold Standard for trainee RP’s.

Previous delegates of our GDP courses have found them inspiring and enjoyable. And the 3-day format will ensure that this is a lively and highly interactive course with practical workshops and exercises throughout the programme.

Plus our experts/tutors (see below) will be available for a 1-2-1 meeting and to chat to over drinks on the first evening.

And, anyone booking on either the March or June event by December 31st will be given 10 free licenses for their team on our online Data Integrity course or 5 free licenses for the online GDP course – normal price over £450. So book now.

I look forward to seeing you there.

Dominic

Unique features of our 3-day RP course include:

During the course delegates will create a training plan and gap analysis for themselves to ensure that they understand the required knowledge and experience they need to satisfy the requirements of an RP
Delegates will have the opportunity to network with the course tutors and other delegates on the evenings of days 1 and 2 including optional 1-2-1 meetings with the tutors
Most of day 3 looks at the importance of a well-designed Quality Management System in ensuring your organisation meets regulatory expectations and outlines how to continually improve your QMS to deliver competitive advantage for your organisation
The 3-day format means this is a lively and highly interactive course with practical workshops and exercises throughout the programme.
For maximum interactivity, our class size is limited to 12 delegates with at least two tutors if there are more than 6 delegates on the course

Course details

Our team of RP and QMS experts

Christine Morris

Christine started her career with Sanofi Winthrop working in QC over 20 year’s ago, moving through to the QA Department and from there into QP training as her career progressed, finally working as Head of Quality. She has extensive experience of working in both ethical and generic pharmaceutical companies and with a wide range of dosage forms. She is eligible to work both as a Qualified Person (QP) and a Responsible Person (RP), having extensive GMP and GDP experience internationally.

Pelleren Hodges

Pelleren has over 30 years’ experience of UK and international logistics and supply chain management within many industries, in particular pharmaceutical (both human and veterinary). He brings common sense and pragmatic solutions to all aspects of the distribution of medicines.

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 15 years, he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.

He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents. He is Managing Director of Inspired Pharma Training Ltd.

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

More details