Sterility Validation 101: Ensuring a Robust Sterilization Validation Program from Start to Finish

On-Demand Available until April 12, 2018

The mapping of a successful sterilization validation program for medical devices can be challenging. From assessing the impact of your manufacturing environment, to your packaging design and choice of sterilization methods, many factors will impact how you validate your sterilization process. While parts of the program are simple, others are very complex, and it can be difficult to know where to begin and what is required.

During this Webinar, you will learn about the many factors to consider when developing and registering a sterile product to ensure your product sterilization process is properly validated and documented, including: 

        •Applicable FDA and international regulations/guidance 

        •Terminal sterilization vs. Aseptic processing 

        •The right sterilization method for the right materials 

        •The impact of your manufacturing environment and processes 

        •Packaging considerations 

        •Sterilization validation and ongoing maintenance sterility testing 

        •Preparing for an audit 

        •Current FDA views on sterilization and the impact to your 510K 





Who should attend? 
Managers, directors, engineers and scientists responsible for research and development, product development, quality assurance and regulatory compliance. 


                   

Speakers



Tami Benjamin, Director, Microbiology, Eurofins Medical Device Testing

With 29 years of Microbiology experience in GMP and GLP testing of medical devices, instruments, biologics, pharmaceuticals, and combination products, Ms. Benjamin has supported the development and regulatory registration of products around the world. Her areas of expertise include sterilization validations, support of clean and aseptic manufacturing operations, as well as the cleaning and reprocessing of reusable devices. As a member of the Orthopedic Surgical Manufacturer’s Association, Ms. Benjamin currently serves on the Sterilization and Cleaning Task Force, as well as the Endotoxin Task Force for Orthopedic Devices and is also an active member of Parenteral Drug Association (PDA), Association for the Advancement of Medical Instrumentation (AAMI) and serves on the Advisory Committee for Health Science Program.


   

John Derek Thompson, CPP, Lead Sterile Packaging Operations Engineer, DePuy Synthes

Mr. Thompson is a Certified Packaging Professional specializing in the areas of project management, design, validation, implementation, compliance and continuous improvement of packaging operations and controlled environments. He has more than 27 years of experience managing manufacturing, packaging and controlled environment integration projects and technical operations and is a Member of the IOPP, IEST, Medical Device Packaging Technical Committee and Chairman of the Packaging Operations Subcommittee. Mr. Thompson is a published author and invited public speaker on excellence in Medical Device Packaging Projects and Operations, including effective collaboration, proactive compliance and environmental control.








About Eurofins Medical Device Testing:
With extensive knowledge of the commercialization process, regulatory requirements and scientific trends in the industry, Eurofins Medical Device Testing offers experienced GMP/GLP/ISO 17025 testing to support the analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs for all types of medical devices. Our global network of 16 laboratories throughout North America, Europe and Asia Pacific provide extensive capacity and the highest level of instrument technology with a full scope of testing services to ensure rapid turnaround times with the highest level of service and most advanced technologies available in the industry.
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