Nelson Labs

Join us to uncover key risks, testing strategies, and best practices for developing reliable, regulatory-ready combination products.

https://www.pharmtech.com/pt_w/drug-device

As combination products continue to advance healthcare, ensuring compatibility between drug formulations and device components is essential for safety and performance. This webinar provides a focused overview of the key principles behind successful combination product development, emphasizing how drugs and devices interact across the product lifecycle.


Participants will explore critical areas including drug stability in contact with device materials, chemical compatibility and interaction risks, biocompatibility considerations, and microbiological safety. The session will highlight potential risks associated with incompatible components and outline testing strategies used to evaluate and mitigate these challenges.


Attendees will leave with a clear understanding of how to assess compatibility, support regulatory expectations, and ensure consistent product quality. This webinar equips professionals with practical knowledge to design and maintain combination products that deliver safe, reliable, and effective therapeutic outcomes.



Packaging, drug compatibility, and quality personnel

Clinical research, compliance, consulting, drug safety, and validation personnel

 is a pharmaceutical industry leader with over 20 years of experience across large pharma, generic drug manufacturers, and contract research organizations. As a Site Leader in Nelson Labs, he leads cross-functional teams across the full drug product lifecycle, from development through commercialization, with deep experience managing multiple business units in CROs and testing laboratories.




Global Segment Director
Pharmaceutical Microbiology

 has worked in the medical device and pharmaceutical industries for over 30 years. She is an experienced scientist and a subject matter expert in many fields of testing, including surface disinfection, filtration sterilization validations, aseptic processing, product microbial activity (potency and preservatives), particulate analysis, container closure systems, contact lens regimen tests, test development, failure investigations, and pharmaceutical product assessments. Her primary tenure has been with Nelson Laboratories LLC where she started in bioburden and radiation sterilization. She participates on the Parenteral Drug Association (PDA), is a co-chair for AAMI/ISO WG9, an executive board member for HCPA, and participates on several Kilmer committees. She enjoys partnering with sponsors to develop test methods, consult, assist with product design, review process controls, and problem-solve.

Webcasts

Webinar Date/Time: Thu, May 14, 2026 2:00 PM EDT

Ensuring Drug–Device Compatibility: Foundations for Safe and Effective Combination Products

Articles

Extractables and leachables (E&L) testing for packaging-related impurities is essential to ensure cGMP compliance and, most importantly, patient safety. 

E&L Testing to Ensure Compliance & Patient Safety

Sterility testing is commonly the first test we think of to determine if something is “sterile”, but in most cases it is not the appropriate test. In this webinar, experts from Nelson Labs review the accepted approach for determining sterility assurance through sterilization and packaging validations.

https://www.pharmtech.com/pt_w/sterility-testing

Sterility testing is commonly the first test we think of to determine if something is “sterile”, but in most cases it is not the appropriate test. In this webinar, experts from Nelson Labs review the accepted approach for determining sterility assurance through sterilization and packaging validations. They will examine sterility testing, including the pros and cons of the methods, to understand when and how testing should be applied. Common case studies where sterility testing is often used will also be presented and better approaches will be suggested.


Learn when sterility testing is and is not appropriate

Understand Test of Sterility versus Test for Sterility

Identify approaches to navigate through specific case scenarios


Expert Technical Consultant
Nelson Laboratories, LLC

 is a recognized authority and industry leader on Radiation Sterilization, Bioburden, Microbiology, and Tissue Processing. He has over 15 years of experience working in laboratory functions in research, test design, media formulation, medical device, and tissue industries. Bryce works with clients in all areas of the world to speak, train, and consult on failure investigations, bioburden issues, establishing bioburden alert and action levels, product family grouping, product adoption, radiation sterilization, and tissue validations.


Bryce has worked with Nelson Laboratories representatives as well as with the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO). He has worked and supported updates for ISO 11737-1 and 11737-2. He has served as the document owner of multiple Nelson Laboratories Standard Testing Protocols (STP), Work Instructions (WI), and Standard Works (SW). He acts as one of the Nelson Laboratories Bioburden, Microbiology, and Radiation Sterilization subject matter experts.


Webinar Date/Time: Wed, Mar 6, 2024 2:00 PM EST





Appropriate Uses for Product Sterility Testing – When is Sterility Testing Appropriate?

Implementing a proper contamination control strategy (CCS) helps ensure product quality and patient safety. Additionally, it is a core element of good manufacturing practices. 

The Development of a Contamination Control Strategy

Understand what constitutes a combination product

Gain a basic understanding of the process for combination product regulatory filing

Understand the basics concepts of the FDA Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff, January 2022