Day 1: Biocomaptibility and the New MDR
Tuesday, August 20, 2019, 09:00 AM PDT
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Day 2: Navigating Packaging changes in light of New Regulatory RequirementsWednesday, August 21, 2019, 09:00 AM PDT |
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Day 3: MDR Effects on Medical Device Processing
Thursday, August 22, 2019, 09:00 AM PDT
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Title: Day 2: Navigating Packaging changes in light of New Regulatory Requirements
Date: Wednesday, August 21, 2019
Time: 09:00 AM Pacific Daylight Time
Duration: 1 hour
Medical Device Testing Regulatory Updates, Trends and Changes including: FDA, ISO and MDR
This three-day webinar will provide engineers and QA/QC/RA managers with an overview of medical device industry trends, updates, and anticipated changes. Three major topics will be covered in three days, including: biocompatibility assessments, packaging integrity testing, and medical device cleanliness testing.
Learn the most up-to-date information about these topics from the Nelson Labs’ experts who sit on the domestic and international committees that set the standards for the industry. These experts understand the day-to-day regulations that impact manufacturers and will be providing relevant, current information for attendees. Come prepared with questions, as ample time for your questions will be provided at the end of each webinar.
Sponsored by:
Day 2: Navigating Packaging changes in light of New Regulatory Requirements
We will look at the new updates to the MDR’s that have driven the ISO 11607 Packaging changes and what that means with the deadline for implementation fast approaching.

Packaging Section Leader
Nelson Laboratories
Wendy Mach has over 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin, antimicrobial effectiveness services. In 2004 Wendy moved to Salt Lake City to accept a position in the EO department at Nelson Laboratories and was responsible for sterilization D-value and packaging microbial aerosol challenge studies.

Packaging Department Scientist
Nelson Laboratories
Jennifer Gygi has over 25 years of medical device laboratory experience. She has worked in the Microbiology, Bioburden, IDs, and Packaging sections at Nelson Labs. Jennifer has experience with various microbial tests, including microbial limits, plate counts, Biological Indicator population verifications, organism ID tests and bioburden tests. Jennifer has spent the last 15 years working in the Packaging group. As one of the original packaging group members at Nelson Labs, Jennifer was heavily involved in validating all the packaging test methods and equipment and writing the test procedures for the packaging tests performed at Nelson Labs.
Event Information
Event Topic:
Navigating Packaging changes in light of New Regulatory Requirements
Event Description:
Date/Time:
Date(s) - 08/21/19
9:00 am - 10:00 am
Event Location:
Other: Free Webinar- but you must pre-register
Event Details
Event Type