IME West | February 7-9, 2023 | Anaheim Convention Center, Anaheim, CA


Join Nelson Labs, LLC for Full Day of Workshop Sessions on Medical Device Validation & Quality Assurance – Reserve Your Seat!

Medical Device Validation – Biocompatibility, Cleaning, Sterilization and Packaging Testing

Wednesday, February 8 from 8:30 a.m. – 4:45 p.m.
Location: Room 207CD

Sessions include:

  • 8:30-9:30 a.m. — Big Changes to ISO 10993-1, what is happening to the main biocompatibility standard now?
  • 9:30-10:30 a.m. — Extractable and Leachable Fundamentals for Success
  • 10:45-11:45 a.m. — Product Adoption for Ethylene Oxide Sterilization
  • 12:00 – 12:45 p.m. — Ask the Expert: Regulatory Hot Topics
  • 1:30-2:30 p.m. —Considerations in Validating Sterilization Dose Using Electron Beam Radiation
  • 2:30-3:30 p.m. —Packaging Sterile Barrier System Validation Concepts and Test Plans
  • 3:45- 4:45 p.m. — Is it time to re-evaluate your Design History File (DHF)?

Speakers:

Jennifer Gygi
Jennifer Gygi
Expert Technical Consultant, Nelson Labs, LLC

Robert Mueller
Robert Mueller
Toxicologist, Nelson
Labs, LLC

Nicole Palluck
Nicole Palluck
Senior Manager, Sterigenics

Alpa Patel
Alpa Patel
Director, Scientific Improvement, Nelson Laboratories, LLC

Thor Rollins
Thor Rollins
Director, Toxicology & E&L Consulting, Nelson
Laboratories, LLC

Zabrina Tumaitis
Zabrina Tumaitis
Radiation Technical
Director, Sterigenics

 


 

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