Science

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs.

The experts at Nelson Labs are teaming with MD+DI to bring a live three-day webinar event that provides manufacturers of medical devices and pharmaceutical products with the most up-to-date regulatory updates, trends, and anticipated changes (including FDA, ISO, USP, and MDRs). Online registration is currently available on the MD+DI website. Many of those speaking contribute to committees that provide global guidance to safeguard patient health; each webinar will offer 15 minutes for audience questions with these experts. Details for each webinar are as follows:

OVERVIEW DAY 1

Title: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes

Date: Tuesday, 26 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will discuss the recent and upcoming changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices. The presentation will include:

  • Discussion about how biocompatibility assessments are affected by the recent updates to the ISO 10993-1 document and the new European MDRs.
  • Anticipated changes to ISO 10993-18. Since the use of chemistry in the biocompatibility assessment of medical devices is gaining traction, the document that outlines how to use chemical characterization for these assessments is undergoing major revisions.
  • An overview of changes that are expected with the acceptance of in-vitro irritation testing.
  • A thorough review of the impact of the recently finalized ISO 18562 standard which specifically targets respiratory contact devices.

Presenters:

Thor Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting

Matthew R. Jorgensen, PhD
Chemical and Materials Scientist

OVERVIEW DAY 2

Title: Sterilization Methodologies and Packaging Integrity Testing: Updates, Trends, and Anticipated Changes

Date: Wednesday, 27 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:
Sterilization methodologies and packaging integrity testing are necessary to ensure patient safety. The sterilization portion of the webinar series discusses recent and upcoming changes to regulatory documents and standards such as:

  • Changes that impact steam, radiation, hydrogen peroxide, and ethylene oxide sterilization modalities.
  • What to expect in the new ISO document for hydrogen peroxide sterilization.

As part of the packaging presentation key points regarding the new European MDRs will be reviewed, including:

  • How medical device manufacturers can collect and document objective evidence of compliance for their packaging, look at designs that prevent microbial contamination at the point of use, and justify that the package is suitable for current use.
  • An introduction to a new leak-testing technology, Mass Extraction, that demonstrates container closure integrity in a non-destructive and rapid manner, will be presented. This new test meets the deterministic requirements as outlined in the newly published USP chapter 1207.

Presenters:

Martell K. Winters, B.S., SM (NRCM)
Director, Scientific Competency

Jason Pope, B.S., ASQ CQA
Senior Scientist

Wendy Mach, RM (NRCM), CQA (ASQ)
Packaging Section Leader

OVERVIEW DAY 3

Title: Cleanliness Testing for Medical Devices: Updates and Trends

Date: Thursday, 28 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will cover the latest updates and current trends for medical device cleanliness testing. This webinar will include:

  • A review of the upcoming and highly anticipated orthopedic implant cleanliness ISO document.
  • A discussion about the testing considerations for certain additive manufacturing processes.
  • Guidance updates for reusable device validations.
  • An update regarding the reprocessing of single-use devices.

Presenters:

Alpa Patel, B.S., RM (NRCM)
Senior Scientist

Alexa Tatarian
Study Director III

Paul L. Littley, B.S.E
Consulting Manager

Nelson Laboratories Science Council

By Martell Winters

I am very excited for this new stage of Nelson Laboratories. For many years I have envisioned that the replacement of Dr. Jerry Nelson would be more than just a single person. The replacement needed to be a small group of highly qualified individuals to help drive the science of Nelson Laboratories.

The Nelson Laboratories Science Council had its first meeting yesterday to confirm the regular participants and discuss the charter and membership qualifications. We have a clear vision of how we will be working together to help expand the knowledge within Nelson Laboratories.

“As we continue to expand as a global leader in microbiological testing services, our scientific expertise is a differentiator for us as a company,” said Jeff Hone, Vice President of Quality at Nelson Laboratories.  “I am so excited to be working with this wonderful group of scientists to expand our scientific knowledge.”

I will serve as the chair of the council, with Tonya Morris as the vice-chair. The regular members of the council are as follows:

  • Martell Winters (Chair; AAMI/ISO participant and co-chair, liaison to AATB standards committee)
  • Tonya Morris (Vice-chair; AAMI/ISO/PDA participant)
  • Thor Rollins (AAMI/ISO participant)
  • Wendy Mach (USP Expert Committee, AAMI/ASTM participant)
  • Michelle Lee (AAMI/ISO/ASTM participant)
  • Alpa Patel (AAMI/ASTM participant)
  • Emily Mitzel (AAMI/ISO participant and co-chair)
  • Dennis Ransom (Master Scientist – Nelson Laboratories)

I look forward to working with this excellent group as we help to improve the science of the 10 Nelson Laboratories facilities, and as we interact in our industry.

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