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.
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 training course for PIC/S Annex 13 GMP requirements is ideal to complete along with other courses including PIC/S Annex 16 (Authorised Person & Batch Release), the Complaints Management course, the Deviations and Non-Conformances management course, the CAPA systems requirements training course.
Course duration: Allow 2 to 4 hours to complete this course.
