Investigational Medicinal Products

4.8

As a QP or quality assurance professional in this challenging area, staying aware of current and upcoming changes to investigational medicinal product (IMP) manufacture is essential. This highly interactive course ensures you stay up to date.

Our training focuses on quality systems and the GMP/GCP interface from the QP or quality leader’s perspective, including key duties and challenges in protecting trials, volunteers and patients. Led by former IMP expert inspectors, QPs and consultants, it provides value to QPs, auditors and those working in clinical trial supply.

This course is delivered in person at a hotel venue in York, UK and is approved by the Royal Society of Chemistry for continuing professional development.

NSF’s GMP for Clinical Trials Manufacture and Supply course can be taken as an alternative if you require different dates, formats or are working toward QP eligibility. Both cover the same core content.

Course Outline

The Clinical Trial and trial phases
Impact of design on manufacturing and packing
Regulatory framework
Annex 13 and Clinical Trial Regulation 536/2014
GMP Regulation 2017/1569 for IMPs
Role and legal duties of the Qualified Person
Key documentation (CTA, IMPD, Product Specification File)
Control and certification of products manufactured or sourced outside the EU
The two-stage release process
QP responsibilities in split manufacture and virtual companies
Special challenges
Good Manufacturing Practice
Sourcing materials, including comparators
Production and quality control of IMPs
Packaging (labelling, blinding, product security)
Validation (how much, how soon?)
Assigning and extending shelf life
Retains and returns
Assessing “equivalence” of GMP standards
Good Clinical Practice and the GMP/GCP interface
Discussion and working groups with case studies and tutor panel sessions

Course Tutors

Course tutors will be selected from the following:

Darren Jones – Former MHRA GMP Inspector with extensive experience auditing commercial and clinical trial dosage forms. With 18 years at AstraZeneca as a QP for IMPs, he brings deep practical expertise in clinical development and real-world quality challenges.

Kate Krachai – QP‑eligible with over 20 years’ industry experience across quality management and lead auditing. Kate has broad expertise in pharmaceutical development, manufacture and supply of marketed and investigational products and the associated quality systems.

Catherine Kay – QP‑eligible with experience in both operational roles and quality assurance, including responsibility for establishing a new solid dose manufacturing and packaging facility.

Ewan Norton – Former MHRA GMDP Inspector with more than 12 years’ inspection experience (including five as Lead Senior Inspector) and accreditation across multiple areas including IMPs, APIs, GDP and unlicensed medicines. Ewan’s 19 years in industry included senior quality leadership, R&D, new product introduction and supporting major MHRA and FDA inspections.

Discounts

Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.

Learning Outcomes

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
Where to focus audits of IMP operations on behalf of a QP
QP duties around IMPs and the GMPs relevant to IMPs

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.