Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

In-house & bespoke training:
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

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Chris Penfold (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Common Technical Document

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Maikel Bouman (bio) , Hans van Bruggen (bio) , Marloes van der Geer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Development of Combination Products: Critical Interactions

In-house & bespoke training

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

Rated by attendees to the public programme

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Effective Technology Transfer

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Bruce Davis (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Keeping Up-To-Date as a (GMP) Qualified Person

In-house & bespoke training

An *In-house* GMP QPs programme providing up-to-date and detailed guidance for current, trainee and returning QPs, to help them fulfil their duties effectively and efficiently in the pharmaceutical Industry.

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Development of ATMPs

In-house & bespoke training

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

Rated by attendees to the public programme

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Packaging, Labelling and Artwork Origination

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by George Barrie (bio)
and 7 more leading experts

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Process Validation with Qualification

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Bruce Davis (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Stability Testing of Pharmaceuticals and Biopharmaceuticals

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Ray Munden (bio) , Allan Watkinson (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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