九州影院

Key learning objectives

On completion of this course, delegates will know and understand:

• The legislation and guidance around clinical trials and what is changing
• The interpretation of GMPs suitable for clinical trials
• The phases in clinical trials and how requirements change
• Auditing and control of clinical trial operations
• The areas of interface between GMP and GCP requirements and how these should be managed
• Clinical batch releases

Course outline

Clinical trials

• What are they?
• Phases of clinical development

EU Legislation Impacting Clinical Supplies

• Annex 13 and Clinical Trial Regulation 536/2014
• GMP Regulation 2017/1569 for IMP鈥檚

EU and FDA expectations compared Good Manufacturing Practice for Clinical Manufacture

• Risk management
• Sourcing of materials, including comparators and supply chain management
• Production and quality control of IMPs
• Documentation
• Packaging issues (labelling, 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
• Quality/technical agreements

Good clinical practice

• What is GCP?
• The GMP/GCP interface 
• Release Procedures and the Role of the QP
• QP responsibilities
• Two-stage release process
• Key challenges

The GMP/GCP Interface

• Issues that fall in the interface
• Audit findings in this area

Shipment to Clinical Sites

• Cold chain supplies
• Transportation

Typical Regulatory Inspection Findings

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]