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CPD Hours: 21
Classroom, online, in-house
The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify. This six-day (two part) module provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. Each major product category is considered separately with respect to common formulations and processing techniques.The course includes exercises on typical situations for the trainee QP to practice decision-making. Sessions on other key areas that a QP must understand including process validation and scale-up, facility design, utilities and sterilisation processes are included. Part one of the course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations.
This is a crucial module for QPs who are, or who will be involved in certifying commercial or investigational batches of medicinal products. The course is most suitable for delegates with no prior or a basic knowledge of the subject however would be of benefit to the more experienced.
By the end of the course you will be able to:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Clive is a chemist by background and an experienced pharmaceutical Qualified Person. Clive has held senior quality positions with Sanofi and Parexel and has expertise is in GMP quality & compliance matters concerning the manufacture of pharmaceutical products. Clive has had both manufacturing site and corporate quality responsibilities. Clive also spent a number of years in pharmaceutical consultancy and during his pharmaceutical career has had direct experience in dealing with major regulatory authorities' inspections, such as US FDA, EU, Japan, China and Russia.
Neil is a Microbiologist with over 30 years experience in the pharmaceutical industry. Neil Treasurer of the Pharmaceutical Quality Group and actively involved in running the annual MHRA/PQG meeting. In 2012 he moved back to a role as QA Group manager, QP and RP on the license at AstraZeneca’s second largest manufacturing site at Macclesfield in Cheshire with primary responsible for the site QMS, internal and external inspections, licensing, issue management and recall. In 2018 he moved to AstraZeneca Corporate Quality as Global Quality Director primarily responsible as Global Business Process Owner for Complaints.
QP pharmaceutical formulation and processing part 1 with practical day
First part of the six day formulation and processing course