"Managing Suppliers to ISO 22442: 2015- Medical Devices Utilizing Animal Tissues and Their Derivatives"
For the life science industries, supplier risk must be effectively assessed and managed as a necessary component of a robust and effective QMS. Field advances in technology and innovation are causing manufacturers to prepare to enter international markets and to become market leaders. Like the FDA, most international regulatory authorities are striving to harmonize by utilizing ISO standards to set overarching requirements. When possible, sourcing biologically derived non-viable animal tissues/derivatives from the food industry can be beneficial to the life science industries. Typically such materials can be otherwise rendered for waste and customer demand offers suppliers an opportunity for additional revenue. This in turn makes food industry suppliers open-minded to work with pharmaceutical, biologics, and medical device manufacturers.
Key takeaways from this session include:
- Overview of supplier management based on impact/criticality to product per ISO 9001, ISO 13485, as well as US FDA 21 CFR 820, 210, and 211
- ISO 22442-Part 1: Risk Management and Part 2: Controls in Sourcing, Collection, and Handling can be applied together to ensure safety of medical devices
- Information regarding general operation of the pork industry and USDA FSIS oversight
- Creating controls for communicating requirements and ensure conformance to ISO 22442-2
- How to plan an audit and ways to effectively assess a food manufacturer’s Quality System
Presenter Bio: Heather Fisher-Clarke
Heather has 10+ years of experience in multiple industries. For 2 years she gained experience in food service management, organic farming techniques, and materials management. For another 2 years she worked in quality for an ISO 17025 accredited lab manufacturing custom standards. As a second, part time job, Heather was a quality/HACCP consultant for a start-up food ingredient manufacturer for 5 years and build a SQF certified QMS from ground up. Heather also developed food testing protocols and managed materials lab completing USDA-funded nutrient analysis projects. Heather worked in quality for a conglomerate company manufacturing FDA approved pet pharmaceuticals and cosmetics. She lead projects to comply with ISO 9001 and FDA/FSMA for customer complaint management, batch reconciliation, material allocation planning and management, supplier management, and implemented and lead a CAPA system. Lastly, for the past 3.5 years Heather has been a Supplier Quality Engineer for a medical device manufacturer and completed over 45 supplier audits and 4 internal audits as a certified auditor. Heather has a B.S in Human Nutrition, Foods, and Exercise: Consumer Foods, Minor in Food Science and Technology. She is also a Certified Quality Auditor, Certified Supplier Quality Professional, Certified Quality Process Analyst, Lead ISO 13485 and ISO 17025 auditor.
Date: Thursday, March 18, 2021
Time: 6:30pm - 8:30pm EST
Where: Virtual Meeting