Courses

GMP

This course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience

An Introduction to Pharmaceutical Packaging

26-27 Sep 2018

Also on: 20 Mar 2019

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

Common Technical Document

4-5 Dec 2018

Also on: 3 Jul 2019

Book by 12 Oct to save
£200 / €280 / $312

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

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

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 2018

Also on: 27 Jun 2019

Book by 5 Oct to save
£100 / €140 / $156

This meeting 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

Book by 5 Oct to save
£100 / €140 / $156

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

Pharmaceutical Development of ATMPs

2-3 Oct 2018

Also on: 4 Apr 2019

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

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

Process Validation with Qualification

16-17 Oct 2018

Also on: 6 Mar 2019

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

Stability Testing of Pharmaceuticals

4-5 Dec 2018

Also on: 3 Jul 2019

Book by 12 Oct to save
£200 / €280 / $312