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

25 Apr 2018

Also on: 26 Sep 2018

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 Jul 2018

Also on: 4 Dec 2018

Book by 9 May to save
£200 / €280 / $312

Data Integrity is a critical issue in document governance. Document Management and Data Integrity are 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.

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

28 Jun 2018

Also on: 3 Dec 2018

Book by 2 May 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 2 May to save
£100 / €140 / $156

A comprehensive overview of the requirements for drug/device and device/drug combination products in the EU and USA

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

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

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 Jul 2018

Also on: 4 Dec 2018

Book by 9 May to save
£200 / €280 / $312