Our latest COVID-19 information/status - including self-paced online learning from our training partner Falconbury

Training & Courses:
GMP

Good manufacturing practices (GMP) are required to conform to the guidelines recommended by agencies that control the authorisation and licensing of the manufacture and sale of pharmaceuticals and medical devices. Our GMP training courses have been designed to ensure that delegates are up to speed with latest developments and best practice.

 

Our spring/summer 2020 programme of London-based courses has been cancelled due to the COVID-19 outbreak. We are taking bookings for our Autumn events, but we are also working to deliver courses and content online. Please contact us if you are interested in an on-site or online version of any of our courses, tailored to your company's needs.

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.

An Introduction to Pharmaceutical Packaging

22-23 Sep 2020

Also on: 17 Mar 2021

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

Includes: Interactive workshops and discussion sessions

Biological Evaluation of Medical Devices

25-26 Nov 2020

Also on: 18 May 2021

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Data Integrity and Document Management

5 Oct 2020

Also on: 5 Mar 2021

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

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

FULLY UPDATED PROGRAMME

Dry Powder Inhalers

23-24 Jun 2021

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

Effective Technology Transfer

1-2 Oct 2020

Also on: 20 Apr 2021

An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.

How to Write Effective SOPs

3 Dec 2020

Also on: 28 Jun 2021

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

An essential annual update for inhalation professionals.

Inhaled Drug Delivery

3-4 Nov 2020

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Injectable Drug Delivery

10-11 Mar 2021

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Metered Dose Inhaler (MDI) Technology

16-17 Sep 2020

Also on: 16 Feb 2021

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Nasal Drug Delivery

15-16 Apr 2021

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.

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Technical Documentation to Comply with the MDR and IVDR

29-30 Sep 2020

Also on: 10 Mar 2021

A practical five-day course with interactive workshops – now in its 17th successful year!

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Excellent.

Hannah Allende, Assistant Clinical Trials Manager, University Hospitals Plymouth NHS Trust

A very talented speaker.

Mario Mohos, Quality Supervisor, Mylan Hungary Kft

Excellent course, highly recommended.

Hannah Allende, Assistant Clinical Trials Manager, University Hospitals Plymouth NHS Trust

The course was absolutely great and to get helpful advice from the experienced speaker was fantastic.

Ulrike Ratz, CMC Manager, Cheplapharm Arzneimittel GmbH

I learned a lot from this course, the speakers were great and they encouraged questions from the attendees. The quiz summarized each part well. My overall opinion is very positive and I would recommend it to my colleagues.

Avital Levertov, Regulatory Affairs Manager, Elcam Medical ACAL

I was hoping for further improvement of my understanding of the matter of inhalational drugs, especially MDI, and this expectation was fully met. The speakers had superb knowledge of the subject, vast experience and a great sense of humour.

Robin Boehm, Team Leader Regulatory Submissions - New Products, STADA Arzneimittel AG

The whole structure has been put together very well.

Dipti Patel , Cunsultant, SGR Consulting Services Ltd

Excellent teacher. Laura presented in an inclusive way and her presentation kept my attention.

Annette Hjemsted, PV Specialist, H. Lundbeck A/S

It was a good course with good shared discussion about many topics and issues. The course material was well organized.

Elen Lasri, Regulatory Affairs Specialist, Elcam Medical ACAL

Very good standard of speakers as always.

Cath Norris, Global Packaging Technologist, Norgine Ltd