GMP for Clinical Trials Manufacture and Supply Training
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 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.
Come and join us in Amsterdam to gain a thorough understanding of GMP requirements for clinical supplies or just to keep up-to-date with what’s changing in this area.
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
Inhalte / Module
- 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 – 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
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
- Stability testing and expiry dating
- How much testing is required?
- How much and how soon?
- Process validation
- Analytical method validation
- Cleaning validation or verification
- 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 IVRS
The GMP/GCP Interface
- Issues that fall in the interface
- Audit findings in this area
Shipment to Clinical Sites
- Cold chain supplies
Typical Regulatory Inspection Findings
This course costs £2.540 plus VAT.
Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Early bird discounts cannot be used in conjunction with multi-delegate discounts.
Kontaktinformation NSF International, Health Sciences
NSF International, Health Sciences
NSF International, Health Sciences
NSF International provides education and training services to lead organisations in the healthcare industry. Courses in health science from NSF International have one goal – to bring change that drives improvements in workplaces. Globally known for high-quality content, NSF International...
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