Annex 13 – Manufacture of Investigational Medicinal Products

USD $35.00

Course duration: Allow 2 to 4 hours to complete this course.

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Description

PIC/s Annex 13 – Manufacture of Investigational Medicinal Products

Includes recent updates to Annex 13 – Manufacture of Investigational Medicinal Products (IMPs) in PIC/S GMP Guides and Annexes in PIC/S PE 009-16 (PIC/S Version 16), effective 1 February 2022.

PIC/S Annex 13 relates to the specific GMP requirements for the manufacture of investigational medicinal products.

This interactive eLearning module covers the latest GMP guidelines and updates in PIC/S V16 for Annex 13 (IMP manufacturing). This online GMP training module provides learners with an understanding of the regulatory compliance requirements for:

  • manufacturing and distributing IMPs and comparator products used in Clinical Trials  
  • recordkeeping and reporting requirements including batch certification and batch release requirements by the Authorised Person (AP)
  • personnel training requirements
  • purpose of blinding and blinding types (definitions of single-blinding, double-blinding, and unblinding codes)
  • preparation and packaging requirements for medical products for clinical trials including:
    • repackaging of comparator products
    • blinding and unblinding mechanisms
    • unblinding codes for use in an emergency
    • other regulations

This eLearning module for manufacturing, production, packaging and blinding controls for Investigational Medicinal Products (IMPs) is suitable for all types of personnel.

Annex 13: Manufacture of IMPs: training course learning objectives

This course is suitable for Quality professionals, clinical researchers, manufacturing/production personnel, contractors, and other clinical laboratory and research personnel involved in the development and/or supply chains for Investigational Medicinal Products being used in Clinical Trials.

The objectives of this Annex 13 IMP training module, based on the latest PIC/S GMP guidance in PIC/S Version 16, and other regulatory compliance requirements for various types of IMPs, are:

  • to provide an understanding of the common terminology used when discussing the manufacture of investigational medicinal products
  • to provide an understanding of validation expectations
  • to provide an understanding of personnel responsibilities and training requirements
  • to provide an understanding of methods used to prevent cross-contamination
  • to provide an understanding of the requirements for Product Specification File (PSF) contents
  • to provide an understanding of Quality Control and Quality Management in relation to these products
  • to provide an understanding of the specific requirements for the complaints, recalls, returns and destruction procedures.

This course is suitable for a worldwide audience.

FDA-Recall-Guidance-CFR-211-CFR-21-806-810.

This regulatory compliance training course for IMPs is suitable for a variety of personnel roles, such as:

  • Quality Management Personnel responsible for batch release
  • Responsible Person or Authorised Person
  • Medicinal Product Developers
  • Healthcare Researchers
  • Clinical Trial Sponsors
  • Clinical Trial Managers and Clinical Trial Coordinators
  • Quality Team Leaders and associates
  • Auditors and GMP Compliance Inspectors
  • Pharmaceutical Product Complaints Personnel
  • Individuals involved with product recalls of therapeutic goods
  • Pharmacovigilance teams or contractors
  • Logistics Managers for Investigational Medicinal Products
  • Medical device manufacturing personnel
  • Medical device quality assurance teams and device maintenance or testing managers
  • Other personnel working in a GMP/cGMP environment
    • Product managers
    • Laboratory testing personnel
    • Operations Managers/Department Managers
    • Customer service/sales representatives
    • Research Data managers
    • Administrative officers and contact personnel
    • Distribution/logistics personnel

 

This newly-released Recalls of Therapeutic Products training course is ideal to complete along with the recently released Complaints Management course, the Deviations and Non-Conformances management course, and the CAPA course.

 

 

Course duration: Allow 2 to 4 hours to complete this course.