Approved training courses

Course description

Please note, the duration of this course is 3.5 days.

The adoption of Council Directive 2001/20/EC means that:
1. All clinical trial materials must be made in accordance with the principles of GMP
2. Manufacturing facilities must hold an appropriate authorisation and will be subject to inspection by the regulatory authorities
3. All investigational medicinal products must be subject to certification by a Qualified Person prior to release into a trial

This course is designed to provide existing, trainee and transitional QPs with the foundation knowledge and understanding required to assess and certify IMPs and to appreciate the fundamental differences between IMPs and licensed products. The following areas are covered:

The Clinical Trial
• The phases of clinical trials
• Impact of trial design on manufacturing and packing operations

Regulatory Framework
• Directives 2001/20/EC and 2005/28/EC
• Annex 13

Role of the Qualified Person
• The legal duties
• Key documentation – the CTA, the IMP dossier and the Product Specification File
• Control and certification of products manufactured or sourced outside the European Union
• The two stage release process
• The role of the QP in split manufacture and in virtual companies
• The special challenges

Good Manufacturing Practice
• Sourcing of materials, including comparators
• Production and quality control of IMPs
• Packaging issues – blinding and product security
• Validation – how much, how soon?
• Assigning and extending shelf life
• Retains and returns
• Assessing ‘equivalence’ of GMP standards

Good Clinical Practice
• What is GCP?
• The GMP/GCP interface – when do the responsibilities of the QP end?

Pre-requisites

Please speak to Aimee Harding, QP Administrator at NSF, about entry requirements for both QP training and/or postgraduate qualifications.

Additional info

Lunches and refreshments are included in the course fee plus a special 'course dinner' on the penultimate evening. Specially negotiated B&B rates are available. For further information please contact Aimee Harding, QP Administrator at NSF.

Venue

Marriott Hotel

Teaching method

Class/lab

City

York

Duration

4 day

Cost

£2590.00 GBP (plus VAT)

Training provider

NSF International

Email

qppharma@nsf.org

Tel

01751432999

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Class/lab
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