iso 22442 TRAINING COURSE OVERVIEW by Mark Durivage
Topic: Animal Tissue and Derivatives Used in Medical Devices
Course Description: This course is intended to introduce those working with animal tissue and animal tissue derivatives used in medical devices to applicable regulations, standards, and guidance. Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide performance characteristics that have been chosen for advantages over non-animal-based materials. The range and quantities of materials of animal origin in medical devices vary. Animal tissue materials can comprise a major part of the device, can be a product coating or impregnation, or can be used in the device manufacturing process.
This course can be used to formally document training to the ISO 22442 International Standards for internal and external auditors.
Course Topics:
- Provide a brief history of the use of animal tissue in medicinal products
- Identify the types of animal tissues
- Discuss Microbiology as applied to animal tissues
- Discuss the ISO Standards for medical devices utilizing animal tissues and their derivatives Including:
- ISO 22442-1 Application of risk management
- ISO 22442-2 Controls on sourcing, collection and handling
- ISO 22442-3 Validation of the elimination and/or inactivation of viruses
and transmissible spongiform encephalopathy (TSE) agents - ISO/TR 22442-4 Principles for elimination and/or inactivation of TSE agents and validation assays for those processes
- Provide an overview of common Risk Management Techniques
- Discuss Production and Post-Production Monitoring Activities
Duration:
1 Day (8 hours)
Location: TBD
Audience:
Internal Auditors
External Auditors
Directors
Managers
Supervisors
Engineers
Technicians
Inspectors
Other: Participants will be administered a pre-test proficiency assessment as well as a post-test
knowledge assessment.
A certificate of completion will be issued for each course participant.
Ready to take this course? Please contact Mark Durivage to find out when the next course will be scheduled.
mark.durivage@qscompliance.com
This document is the property of Quality Systems Compliance LLC and is delivered on the express condition that it and the information contained in it is not to be used, disclosed or reproduced in whole or in part, for any purpose that is not expressly authorized in writing by Quality Systems Compliance LLC. Quality Systems Compliance LLC is not responsible or liable for any use, disclosure or reproduction of the document, whether in whole or in part, that is beyond the specific purpose for which it was created or developed. Any unauthorized use of this document is at the user’s risk. Rev 4.0 10/22/2018