Course description
GMP for Clinical Trials Manufacture and Supply
Keeping up with the changing legislation for clinical trials provides challenges for all those working with investigational medicinal products. This highly interactive training course 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 (e.g. the Tic Tac double dummy packaging exercise), 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 ex-MHRA inspectors and experts in the field of clinical trials manufacturing and regulatory requirements, and teach you simple and pragmatic ways of working designed to help you better meet the needs of the regulators.
This course is approved by the Royal Society of Chemistry and is suitable for its members continuing professional development.
Upcoming start dates
Suitability - 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.
Outcome / Qualification etc.
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
Training Course Content
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
Annex 13 Requirements for IMPs
- EU and FDA expectations compared Whats 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
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 Labelling
- 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
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 IWRS
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
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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Expenses
Discounts
Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.