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Day One Agenda
Wednesday, March 13

*All Times Central US

8:30   ZOOM SIGN-ON & VIRTUAL COFFEE
• Private & public text chat
• Interactive polling
• Tech check

8:50   OPENING REMARKS

9:00   PANEL DISCUSSION: ADDRESSING CAPACITY ISSUES & DEBATING REMEDIATION STRATEGIES
• Mapping the current state of capacity limitations
• Opportunities in outsourcing to other facilities
• Forward-thinking & innovative ideas to overcome constraints
• Forecasting the evolution of capacity over the next 5 years
Thomas Kroc, FERMILAB
Roberto Zumbado, , PHILIPS
Thomas Bunch, IBA
Aaron Starkey, IBA

9:45   PLENARY DISCUSSIONS: SHARING PATHS, PITFALLS & SOLUTIONS IN THE IMPLEMENTATION OF AN ALTERNATE STERILIZATION METHOD
Many companies are attempting to switch sterilization modalities, however various factors of critical importance weigh in the decision to initiate the transfer. By engaging with peers, participants in the session are given the unique opportunity to exchange ideas and solutions to common hurdles in the process of mapping out, as well as initiating and executing the transition.
Stephanie Volk, Sr. Corporate Sterilization & Biocompatibility Specialist
CONVATEC USA

10:15   VIRTUAL COFFEE & NETWORKING BREAK

10:45   PLENARY DISCUSSION: EXPLORING THE USE OF ALTERNATIVE STERILIZATION METHODS
• Outlining currently accessible sterilization options outside of EO
• Addressing challenges in accessing X-ray & further alternatives
• Pros & cons of specific sterilization methods to consider
• Factors weighing in the decision to initiate a modality transfer
Thomas Bunch, Product Line Manager
IBA
Aaron Starkey, Sales Director
IBA

11:15   MASTERING REGULATORY ASPECTS OF TRANSFERRING TO A NEW STERILIZATION MODALITY
• Defining regulatory requirements in shifting to a new process
• Data focus: Structuring a rationale & documenting the transition
• Ensuring a sound approach to the validation of the new modality
• Necessity to file another 510k in light of the updated sterilization method
Stephanie Volk, Sr. Corporate Sterilization & Biocompatibility Specialist
CONVATEC USA

12:00   TCEQ: SCIENTIFIC ISSUES WITH THE ASSESSMENT OF EO CANCER RISK
• Review of dose-response assessment issues
• Scientific weight-of-evidence for the best model
• Update on review of TCEQ’s assessment by NASEM
• Implications of best available science for EO regulations
Joseph Haney, Toxicologist
TEXAS COMMISSION ON ENVIRONMENTAL QUALITY

12:45   VIRTUAL COFFEE & NETWORKING BREAK

1:15   PRACTICAL CASE STUDIES: LEARNING FROM PEERS ON OPTIMIZING DOSE MAPPING PRACTICES THROUGH SIMULATIONS
Given the fruitful opportunities in the application of dose mapping simulations, sterilization professionals are eager to obtain practical information from peers’ experiences in order to assess the pertinence and potential pitfalls to look out for with a specific method. Sharing on challenges and solutions, each presenter in this session will shed light on steps taken to achieve the method selection process, as well as execution of dose mapping simulations.
James McCoy, Global Program Manager, R&D, Corporate Sterility Assurance
BECTON DICKINSON

2:00   THE DRIVE TOWARDS ALTERNATIVE MODALITIES SUCH AS E-BEAM & X-RAY
• Reviewing Post-Pandemic landscape of Terminal Sterilization Industry
• Analyzing Recent events affecting overall industry
• Inspecting Industry Trends and Novel Modalities
• Evaluating the emergence of E-beam/X-ray technology as optimal terminal sterilization strategy
Jeff Sauter, Director of Business Development
STERITEK

2:45   Closing Remarks & End of Day 1

Day Two Agenda
Thursday, March 14

*All Times Central US

8:30   ZOOM SIGN-ON & VIRTUAL COFFEE
• Private & public text chat 
• Interactive polling 
• Tech check

8:50   OPENING REMARKS

9:00  SESSION 9 – FIRESIDE CHAT: ADDRESSING NOTIFIED BODY PERSPECTIVES ON FULFILLING MDR REQUIREMENTS SPECIFIC TO STERILIZATION
Given the heightened regulatory requirements to obtain the MDR CE mark, sterilization executives seek further clarity in fulfilling notified body expectations to better comprehend how to structure and carry out an optimal strategy, fitting EU-level demands. This interactive session enables attendees to address specific questions to notified body experts, and gain insight into areas of scrutiny in notified body reviews pertinent to sterilization.
INTERVIEWEE:
Charlotte Negrón-Morales, Product Reviewer
GMED
INTERVIEWER:
Stephanie Volk, Sr. Corporate Sterilization & Biocompatibility Specialist
CONVATEC USA

9:45   BRIDGING THE GAP WITH R&D TO ENSURE A PROACTIVE APPROACH TO OPTIMIZED STERILIZATION
• Educating R&D teams in currently available sterilization methods
• Close collaborations to ensure sterilizable product design
• Reaching sterilization-agnostic devices to enable flexibility
Thomas Kroc, Applications Physicist for Technology Development
FERMILAB

10:30   VIRTUAL COFFEE & NETWORKING BREAK

11:00   KEY CONSIDERATIONS IN MATERIAL TESTING PRIOR TO ADOPTING A NEW STERILIZATION PROCESS
• Results of coloration, mechanical and functionality testing of medical devices and the associated
  constituent polymers
     » Comparing the effects between cobalt-60 gamma, E-beam and X-ray
     » Measuring how these effects are influenced by dose level, temperature and oxidative atmospheres  
        during irradiation
     » Measuring how these effects are influenced by the magnitude of E-beam energy (1-10 MeV)

• Features of the latest version of the new PUFFIn dose distribution software
Leo Fifield, Senior Research Scientist
Mark Murphy, Senior Research Scientist
Randolph Schwarz, Nuclear Engineer
PACIFIC NORTHWEST NATIONAL LABORATORY

11:45   SMALL GROUP DISCUSSIONS: BRAINSTORMING SOLUTIONS TO STERILIZATION CHALLENGES PER COMPANY SIZE
While small, medium-sized and large organizations face similar challenges in the overall shift when it comes to sterilization, however there can be differences as well. Company size specific available monetary and human resources will mark a difference in the possibilities of transferring to different modalities. By engaging with peers from comparable-sized companies, participants in the session are given the opportunity to exchange ideas and solutions to common hurdles.
MODERATOR:
Betty Howard, Sr. Radiation Sterilization Manager
STERIS
GROUP 1: Small (< 100)
GROUP 2: Medium (<100 to >250)
GROUP 3: Large (< 250)

12:15   VIRTUAL COFFEE & NETWORKING BREAK

12:45   DEVELOPING STERILIZATION STRATEGY FOR A RESILIENT & SUSTAINABLE SUPPLY CHAIN
Pressures on the ability for companies to sterilize medical, bioprocess and labware
products continue to grow. An aging population that benefits from a host of medical devices to improve and prolong their lives, along with an uptick in drugs and vaccines that use single-use systems in large scale production have increased demand on existing global sterilization assets.
This demand is currently outpacing the sterilization market’s ability to provide timely access to capacity. Recent challenges in the supply of a key radiation sterilization source, cobalt-60, and pressure on EtO use from an environmental perspective combined with an increased focus on sustainable supply chains and total cost (money and carbon) to sterilize further complicate the picture. Without a comprehensive and effective strategy to address access to capacity and the cost to secure it will limit companies’ ability to grow. This talk will provide some key considerations primarily related to radiation sterilization when building a sterilization strategy for the short and long term.
Thomas Bunch, Product Line Manager
IBA

1:30   PANEL DISCUSSION: TRAINING & RETAINING TALENT TO DRIVE STERILIZATION EFFORTS
• Challenges to identify & hire talent with specific product knowledge
• Continuous training on evolving technology & sterilization landscape
• Best practices in minimizing staff turnover & ensuring retention
Samantha Hodge, MEDTRONIC
James McCoy,, BECTON DICKINSON
Brian Riggs,W.L. GORE & ASSOCIATES

2:15   Closing Remarks & Conference Conclusion