Navigating Packaging changes in light of New Regulatory Requirements

View
Webcasts
Select one or more of the following webcasts and complete registration. Click any webcast listing to view its details.
Day 1: Biocomaptibility and the New MDR

Tuesday, August 20, 2019, 09:00 AM PDT

Day 2: Navigating Packaging changes in light of New Regulatory Requirements

Wednesday, August 21, 2019, 09:00 AM PDT

Day 3: MDR Effects on Medical Device Processing

Thursday, August 22, 2019, 09:00 AM PDT

Overview

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

Summary

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:
Nelson Labs


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.

Wendy Mach, B.S., RM (NRCM), CQA (ASQ)
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.

Jennifer Gygi
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