Name: Annex 13 - Manufacture of Investigational Medicinal Products
Price: 35.00 USD
Availability: InStock

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
- Including Advanced Therapeutic Medicinal Products (ATMPs)
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