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Investigational Medicinal Products

NSF International, Pharmaceutical Services
Course summary
3.5 days
2,590 GBP excl. VAT
York
Next available date: 22/06/2020 08:30 - York

Course description

Investigational Medicinal Products

This three-and-a-half-day course focuses on the quality systems and the GMP/GCP interface from the Qualified Person or quality leader’s perspective. It focuses on the QP’s duties and challenges in protecting trials, volunteers and patients. Led by former IMP expert inspectors, QPs and current consultants, this highly interactive course adds value to QPs, auditors and those working in clinical trial supply.

*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.

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.

Training Course Content

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?

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

Reviews

Average rating 4.5

Based on 2 reviews

Beth Halliday, Penn Pharmaceutical Services, UK
(4)
Medicinal Chemistry was my first QP module and I thoroughly enjoyed it. It’s very personal and supportive. Looking forward to the next one.
Jacqueline Barry, Scottish National Blood Transfusion Service, UK
(5)
The subject matter is complex but it wasn’t presented in a complex way, but rather a clear and consistent way.
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Case Study
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NSF International, Pharmaceutical Services

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