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GMP for Clinical Trials Manufacture and Supply

NSF International, Pharmaceutical Services
Course summary
3.5 days
2,470 GBP excl. VAT
Amsterdam

Course description

GMP for Clinical Trials Manufacture and Supply

This highly interactive three-and-a-half-day training course will teach 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. Our tutors, both of whom are former regulatory agency inspectors, will help you to interpret the legislation and guidance into simple pragmatic ways of working that meet the needs of the regulators. They will also help to answer any specific questions you may have regarding your products and studies.

Keeping up with the changing legislation in the area of clinical trials provides challenges for all those working with Investigational Medicinal Products. Our highly interactive 4-day course is taught by ex-MHRA Inspectors; all experts in the field of clinical manufacturing and regulatory requirements. This provides an excellent opportunity for gaining invaluable knowledge about the ever-changing world of clinical supplies.

Practical exercises in this course (such as the “Tic Tac” double dummy packaging exercise) help to reinforce key learning points. 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 also Royal Society of Chemistry approved as suitable for their members’ Continuing Professional Development.

*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.

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 – 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 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

Expenses

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

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


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