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Home > Voices In Validation > Sterilization and Sterility Assurance in Medical Device Packaging
Podcast: Voices In Validation
Episode:

Sterilization and Sterility Assurance in Medical Device Packaging
Category: Science & Medicine
Duration: 00:57:27
Publish Date: 2021-03-02 05:00:00
Description:

This week, Stacey is joined by Roberta Goode to talk about patient safety and how medical packaging is a key component of that. Stacey and Roberta discuss the nuts & bolts around “Selecting medical device packaging materials and sterilization methods to achieve appropriate sterility assurance levels and sterile barrier integrity throughout the labeled shelf life.”

Resources from this episode:

ISO 14971:2019 Medical devices – Application of risk management to medical devices - https://www.iso.org/standard/72704.html

ISO 24971:2020 Medical devices – Guidance on the application of ISO 14971 - https://www.iso.org/standard/74437.html

ISO 11607:2019 Packaging for terminally sterilized medical devices - https://www.iso.org/standard/70799.html

ISO 13485:2016 Quality Management System for medical devices - https://www.iso.org/standard/59752.html

21 CFR 820 Quality System Regulation - https://www.govinfo.gov/app/details/CFR-2011-title21-vol8/CFR-2011-title21-vol8-part820

ASTM D4169 -16: Standard Practice for Performance Testing of Shipping Containers and System - https://www.astm.org/DATABASE.CART/HISTORICAL/D4169-09.htm

ISTA 2a: Partial Simulation Performance Tests - https://ista.org/test_procedures.php

Roberta Goode, Principal, Altrec

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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