BioOhio, NAMSA, and E-BEAM Services invite you to join your colleagues for a complimentary half day forum including presentations, Q&A, lunch, and a tour of an electron beam radiation sterilization facility.
The forum brings together industry experts to discuss a variety of regulatory topics necessary for a successful medical device launch, with a highlight on the sterilization component. Attendees will have an opportunity to engage in an open dialogue about the growing regulatory environment surrounding medical device companies, while gaining a more comprehensive understanding of the electron beam sterilization method, including materials characterizations and validation of the sterilization process.
Topics will include: regulatory strategies, quality assurance, sterilization technologies and methods with a focus on electron beam, sterilization standards, and critical factors in product design and packaging decisions.
Recommended for:
- Start-up or small companies
- Regulatory
- Quality medical device and manufacturing staff
- Anyone seeking information to help them better understand the principles and science of sterilization and the regulatory environment!
AGENDA
Registration 8:30 am
9:00 Welcome and Introduction – BioOhio, NAMSA, and E-BEAM Services
9:15 Global Regulatory Pathways: Plan for Successful Submissions
10:15 Break
10:30 How to Validate a New Product (NAMSA & E-BEAM Services)
11:30 The Science of Sterilization & Overview of Sterilization Technologies
12:30 Panel Q&A
Lunch/Networking
1:30 E-BEAM Tours