Course description
Investigational Medicinal Products - QP Module
As a QP or quality assurance auditor in this challenging area, are you aware of the current and planned changes around the manufacture of investigational medicinal products (IMPs)? This highly interactive IMP training course makes sure you are up to date.
This course focuses on the quality systems and the Good Manufacturing Practice (GMP)/Good Clinical Practice (GCP) interface from the QP or quality leader’s perspective. More specifically, the QP’s duties and challenges in protecting trials, volunteers and patients. Led by former IMP expert inspectors, QPs and current consultants, this course adds value to QPs, auditors and those working in clinical trial supply.
This course is also Royal Society of Chemistry approved as suitable for their members’ continuing professional development (CPD).
Suitability - Who should attend?
The Aspiring Qualified Person
- Our training is generally considered as the best available and our QPs are held in high regard within 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 within 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.
Find out why you should choose NSF for your QP training by visiting our qualified person training section.
Outcome / Qualification etc.
Key Learning Objectives
On completion of our IMP training course delegates will know and understand:
- The new regulations and requirements for the QP
- The subjects required in the IMP element of the 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
- IMPs, Falsified Medicines Directive (FMD) and validation
Training Course Content
Course Outline
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?
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 4.5
The tic‐tac exercise was a great way to show the complications relating to IMP packing. The presentations were also really useful.
Medicinal Chemistry was my first QP module and I thoroughly enjoyed it. It’s very personal and supportive. Looking forward to the next one.
Expenses
Discounts
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
Another great course with great teamworks and tutors/guest speakers ‐ thank you.