GMP for Clinical Trials Manufacture and Supply Training

Currently there are no upcoming GMP for Clinical Trials Manufacture and Supply Training courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.

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About This Course

Keeping up with the changing legislation for clinical trials provides challenges for all those working with investigational medicinal products. This highly interactive training course, delivered over four half-days, teaches you all you need to know about international GMP regulations and requirements for the manufacture, control, storage and distribution of medicines to be used in clinical trials manufacture.

Using practical exercises, our clinical trial GMP training tutors help you to gain a better understanding of the ever-changing world of clinical supply and its legislation. Our tutors are a combination of ex MHRA inspectors and current IMP QPs, and teach you simple and pragmatic ways of working designed to help you better meet the needs of the regulators.

This training will be delivered as a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

This course is approved by the Royal Society of Chemistry and is suitable for its members’ continuing professional development.

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

  • The new CT Regulation 536/2014
  • The current CT Directive 2001/20/EC
  • The GMP Directive 2003/94 and the proposed changes
  • EU and FDA expectations compared – What’s changing?

Annex 13 Requirements for IMPs

  • EU and FDA expectations compared – What’s changing?

Product Development and Design

  • Product and process understanding
  • Risk-based thinking

Supply Chain Management

  • Controls on starting materials
  • Controls on contractors
  • Importation requirements
  • Sourcing comparators
  • Release procedures
  • Quality/technical agreements
  • Section 19 of EudraLex Vol 4 Part 2

GMP Requirements for APIs

  • Section 19 of EudraLex Vol 4 Part 2

GMP Considerations for Clinical Manufacture

  • Minimizing cross-contamination
  • The application of ICH Q10
  • The importance of risk management
  • The importance of the change management system
  • Protecting the patient and the trial data

Packaging and Labeling

  • Controls of packaging components
  • Printing and label controls
  • Blinding issues
  • Practical considerations

QC Requirements

  • Stability testing and expiry dating
  • How much testing is required?

Validation Issues

  • How much and how soon?
  • Process validation
  • Analytical method validation
  • Cleaning validation or verification

Documentation

  • What is in an IMPD?
  • The importance of a product specification file
  • What is it and why is it important?

Data Integrity in Clinical Trial Manufacture

  • What is it and why is it important?

Release Procedures and the Role of the QP

  • QP responsibilities
  • Two-stage release process
  • Use of IVRS

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.

Course Tutors

Darren Jones - Darren is an ex-MHRA GMP Inspector and has audited dosage forms for both commercial and clinical trial applications. Darren also has a wealth of practical knowledge and experience applying GMP in the clinical development world gained during his 18 years with AstraZeneca, prior to joining the MHRA. He was a Qualified Person for IMPs and knows the real challenges and how to overcome them.

Richard Funnell - Richard spent 11 years with the MHRA, including seven as a Senior GMP Inspector with the lead for IMPs. Richard has current knowledge and understanding of what inspectors are looking for in the lead up to the new clinical trial regulations.

Kate Krachai - has over 20 years’ experience in the pharmaceutical industry as a proactive quality manager and pharmaceutical lead auditor, working to enrich quality systems and compliance with companies of varying sizes globally.

Discounts

Multi-delegate discounts available. Discounts also offered to NSF staff, regulators and charities.