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GMP for Clinical Trials Manufacture and Supply

NSF International, Pharmaceutical Services
Course summary
3.5 days
2,450 GBP excl. VAT
English
Full time
Online courses
Next available date: 02/11/2020 08:45 - Online courses

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.

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.

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

Why choose NSF International, Pharmaceutical Services

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert pharmaceutical training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

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

Customer Outreach Award

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We believe that it should be easy for you to find and compare training courses. 

Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.

About provider

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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