Presented by
Management Forum
This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.
20-21 November 2023
+ 13-14 March 2024, 17-18 July 2024, 18-19 November 2024
from £1099
An active pharmaceutical ingredient (API) or drug substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product, which is intended to furnish pharmacological activity, or have another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affect the structure and function of the body.
This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain. Practical exercises will form part of the course to aid the learning process.
This is an essential and valuable introduction to the manufacture of APIs.
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
20-21 November 2023
Live online
09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Course code 12879
Until 16 Oct
Not ready to book yet?
for 7 days, no obligation
13-14 March 2024
Live online
09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
05:30-13:30 New York (UTC-04)
Course code 13585
Until 07 Feb
Not ready to book yet?
for 7 days, no obligation
17-18 July 2024
Live online
09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Course code 13834
Until 12 Jun
Not ready to book yet?
for 7 days, no obligation
18-19 November 2024
Live online
09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Course code 14052
Until 14 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Germany
Netherlands
Poland
Slovak Republic
United Kingdom
United States of America
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: