九州影院

Key Learning Objectives

On completion of our IMP training course delegates will know and understand:

• The regulations and requirements for the IMP QP, as well as upcoming changes
• The requirements of the IMP module in the UK QP study guide
• What regulators and inspectors look for
• How to prepare for your next inspection or IMP audit
• Where to focus audits of IMP operations on behalf of a QP
• QP duties around IMPs and the GMPs relevant to IMPs

Course Outline

The Clinical Trial

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

Regulatory Framework

• Annex 13 and CT Regulation 536/2014
• GMP Regulation 2017/1569 for IMP's

Role of the Qualified Person

• The legal duties
• Key documentation, e.g. the Clinical Trial Authorisation (CTA), IMP dossier and 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
• 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 鈥渆quivalence鈥� of GMP standards

Good Clinical Practice

• What is GCP?
• The GMP/GCP interface (when do the responsibilities of the QP end?)

Discussion and Working Groups

A significant portion of course time is devoted to group work. Using case studies, delegates have the opportunity to put theory into practice. In addition, discussion periods (which include a course tutor panel session) provide delegates with an opportunity to obtain answers to their specific question and concerns.

Who Should Attend?

The Aspiring Qualified Person

• Our training is generally considered the best available and our QPs are held in high regard in the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries including Ireland, the Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider.

The Pharmaceutical Technical Professional

• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact [email protected].

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit for current dates. If you cannot see your delivery method of choice, please contact [email protected].