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Training courses & Webinars:
GxP

GxP (Good x Practice) is a series of quality guidelines and regulations created to ensure that bio/pharmaceutical products that are consumed, or used by humans or animals are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. GxP is an abbreviation of referencing the various ‘good practice’ regulations in the life sciences industry. G (Good) P (Practice) x (variable depending on the application) covers a wide range of processes used in development, manufacturing and distribution of regulated products, such as; Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP) etc. We offer a range of essential GxP training across a variety of areas to ensure you comply with the regulations and quality guidelines.

 

An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

28-29 Mar 2022 - Online webinar
Also on: 13 Jun 2022

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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Common Technical Document Training Course

Common Technical Document

1-2 Feb 2022 - Online webinar
Also on: 5 May 2022

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Presented by Maikel Bouman (bio)
Hans van Bruggen (bio)
Marloes van der Geer (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

5-6 May 2022 - Online webinar
Also on: 7 Nov 2022

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Effective Technology Transfer Training Course

Effective Technology Transfer

11-12 Jan 2022 - Online webinar
Also on: 6 Apr 2022

The ‘how to’ of technology transfer across the product lifecycle

Presented by Bruce Davis (bio)

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

25-26 Apr 2022 - Online webinar
Also on: 13 Jul 2022

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

27-28 Jun 2022 - London
Also on: 12 Dec 2022

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Presented by George Barrie (bio)
and 6 more leading experts

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Process Validation with Qualification Training Course

Process Validation with Qualification

14-15 Mar 2022 - Online webinar
Also on: 20 Jun 2022

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

1-2 Dec 2021 - Online webinar
Also on: 14 Jul 2022

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Presented by Ray Munden (bio)
Allan Watkinson (bio)

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[The speaker] was very friendly, professional and thoughtful. He encouraged all the trainees to participate in the exercises in a very positive & constructive way.

Grace Jung , Senior Scientist, Design Transfer, Speedx Pty Ltd

An excellent 2 days - required lots of concentration but worth it. It was very engaging and encouraged me to continue learning and improving.

Jane Kean, Regulatory Associate, Elanco UK AH Limited

The speaker was very clear and enabled participants to ask questions with a lot of patience and with clear answers.

Yaniv Menachem, Regulatory Affairs Specialist, Elcam Medical ACA Ltd.

Overall I quite enjoyed the webinar. Everything was thoughtful and easy to perceive. Particularly I liked the part when speaker introduced with the requirements of registration purposes in United States and compared with EU regulations.

Alise Spakevica, , AS Kalceks

Very engaged and competent speaker.

Alis van der Aa Kühle, Delegated QP, Fujifilm Diosynth Biotechnologies

Very good.

Sylwia Andrzejewska, Stability Coordinator CTM Analytics Austria, CTM Analytics, Valneva Austria GmbH

Overall content of the webinar was very good and covered a lot of topics.. The presentation was clear and included a lot of information. I believe this course was very informative and covered a breath of information in regards to combination product and i gained a lot of useful information and knowledge.

Rebekah Coke, Regulatory Affairs Specialist , Bespak Europe Ltd, Recipharm

I feel the content was detailed and informative.

Anisa Mohamed, Regulatory Affairs Officer, Welsh Blood Service

I am very pleased with the webinar.

Astrid Beck Vestergaard, Quality Assurance, Cytovac

I liked Andrew's teaching methods mainly engagement of participant all the way through the course.

Rehab Alnabhan, , Miltenyi Biotec B.V. & Co. KG