AGENDA
12:00 - 1:00 PM
Registration - Coffee & Tea
1:00 - 1:15 PM
Chairperson's Opening Remarks
1:15 - 2:15 PM
Panel: Annex 1 & the Impact on Cleanroom Management, Environmental Monitoring, & Cleaning Validation
Moderator: TBD Panelists: Cindy Duhigg, Global Process Validation Steward, Alcon Jason Kelly, Director of Applications, Lighthouse Worldwide Solutions Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine Liz Brockson, Aseptic Processing & Sterility Assurance Lead, Takeda Marsha Steed, Sr. Consultant, JYA and Founder & President, Steed MicroBio LLC Sharif Uddin, Ph.D., Principal Engineer Process Cleaning, Rockline Industries Sheba Zaman, Head of Product Specialists and Training Services, Novatek International
2:15 - 3:00 PM
Advancements in Cleanroom Technology: Explore Emerging Trends
Cindy Duhigg, Global Process Validation Steward, Alcon
3:00 - 3:30 PM
Networking Refreshment Break and Exhibit Showroom
3:30 - 4:00 PM
Bridging the Gap -Aligning Your Processesto theAnnex 1 Update
Amy Bradford, Principal Consultant-Quality/Micro, CAI
4:00 - 4:30 PM
Harness GenerativeAIfor Enhanced Cleanroom Validation, Disinfection, and Environmental Monitoring
Arielle Musa, Microbiology Specialist, Johnson & Johnson
4:30 - 5:00 PM
Annex 1 & Rapid Microbiological Methods
Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory Precision for Medicine
5:00 PM
Networking Cocktail Reception
8:00-9:00 AM
Exhibitor Showroom Opens and Lite Breakfast
9:10- 10:00 AM
Select Between Knowledge Exchange Sessions
9:10- 10:00 AM
CelsisATPBioluminescence Technology forRapid Sterility Testing
Nathan Wasilko, Ph.D, Scientist II, Charles River Laboratories
Cleanroom
Contamination
Control
9:10- 10:00 AM
Live Demo -Validation of Particle Lossesfollowing ISO/TR14644-21:2023
Jason Kelly, Director of Applications, Lighthouse Worldwide Solutions
Environmental
Monitoring
9:10- 10:00 AM
CleaningValidation Program Design -ARisk-based LifecycleApproach
David W. Vincent MPH, Ph.D, Chief Scientific Officer, VTI Life Sciences
Cleaning
Validation
10:05- 10:45 AM
Select Between Knowledge Exchange Sessions
10:05- 10:45 AM
Cleanroom Chemistries – What and why?
Daniel Klein, Senior Manager Microbiology and Clinical Affairs, STERIS Corporation
10:05- 10:45 AM
Navigate the Challenge ofAccurate Microbial Identification
Ratul Saha Ph.D., Director, Global Sterility Assurance Programs, Bausch & Lomb
10:05- 10:45 AM
Master Isolator Cleaning& Disinfection:Best Practices Unveiled
TBD
10:45- 11:00 AM
Exhibitor Showroom and Refreshment Break
11:10- 12:00PM
Select Between Knowledge Exchange Sessions
11:10- 12:00PM
Disinfectant Efficacy Testing:A Critical Component of aValid Contamination Control Strategy
Anthony Grilli, CEO & Owner, FOCUS Laboratories
Cleanroom
Contamination
Control
11:10- 12:00PM
Case Study: Machine Learning in Microbiology
Arielle Musa, Microbiology Specialist, Johnson & Johnson
Environmental
Monitoring
11:10- 12:00PM
Hygienic Design Mastery: Elevate Your CleaningValidation Standards
Sharif Uddin, Ph.D., Principal Engineer Process Cleaning, Rockline Industries
Cleaning
Validation
12:00- 1:00PM
Lunch and Learn
1:10- 1:50PM
Select Between Knowledge Exchange Sessions
1:10- 1:50PM
Performing FacilityAnnex 1 Compliance GAPAnalysis
David W. Vincent MPH, Ph.D, Chief Scientific Officer, VTI Life Sciences
Cleanroom
Contamination
Control
1:10- 1:50PM
Craft an Effective Environmental Monitoring and Contamination Control Strategy
Liz Brockson, Aseptic Processing & Sterility Assurance Lead, Takeda
Environmental
Monitoring
1:10- 1:50PM
Hot Topicsin Cleaning - Stainless Steel Equipment Maintenance andAir
Sunil Patel, Regional Leader (South Central), IPS-Integrated, Project Services
Cleaning
Validation
2:00-3:00PM
Liquid Interface Rings
3:10-3:50PM
Select Between Knowledge Exchange Sessions
3:10-3:50PM
Navigating theBarriersAssociated with ImplementingAlternative Microbiological Methods
Nathan Wasilko, Ph.D, Scientist II, Charles River Laboratories
Cleanroom
Contamination
Control
3:10-3:50PM
Perfecting Your Environmental Monitoring Program
Jason Kelly, Director of Applications, Lighthouse Worldwide Solutions
Environmental
Monitoring
3:10-3:50PM
From Surface to Success: Craft a Comprehensive CleaningValidation Program
Christiana Ellis, Cleaning Validation Manager, Vertex Pharmaceuticals
Cleaning
Validation
4:00-4:40PM
Select Between Knowledge Exchange Sessions
4:00-4:40PM
Contamination Control Strategy forAseptic Environments- Program Development,Validation, Maintenance
Liz Brockson, Aseptic Processing & Sterility Assurance Lead, Takeda
Cleanroom
Contamination
Control
4:00-4:40PM
Qualifying Your Disinfection Program Using Environmental Monitoring
Donald Singer, Senior Microbiology Technical Consultant, Ecolab Life Sciences
Environmental
Monitoring
4:00-4:40PM
Revolutionize CleaningValidation: Embrace the Modern Era
Cindy Duhigg, Global Process Validation Steward, Alcon
Cleaning
Validation
4:50-5:00PM
Exhibitor Showroom and Refreshment Break
5:00-5:30PM
Select Between Knowledge Exchange Sessions
5:00-5:30PM
Mold and Microbial Contamination andRemediation
Daniel Klein, Senior Manager Microbiology and Clinical Affairs, STERIS Corporation
Cleanroom
Contamination
Control
5:00-5:30PM
Develop and Implement aRisk-based Non-sterile Program
Cindy Duhigg, Global Process Validation Steward, Alcon
Environmental
Monitoring
5:00-5:30PM
Conduct a GapAnalysis of Your CleaningValidation Program
Sunil Patel, Regional Leader (South Central), IPS-Integrated Project Services
Cleaning
Validation
8:00-9:00 AM
Exhibitor Showroom Opens and Lite Breakfast
9:10-9:50 AM
Select Between Knowledge Exchange Sessions
9:10-9:50 AM
Cross Contamination & Smoke Studies
Dawn Marshall, Global Quality - Site Support, Sanofi
Cleanroom Contamination Control
9:10-9:50 AM
Creating an Environmental Monitoring Program for Isolator Units
Jason Kelly, Director of Applications, Lighthouse Worldwide Solutions
Environmental Monitoring
9:10-9:50 AM
Efficiency Unleashed: Strategiesfor Streamlining CleaningValidation Processes
Christiana Ellis, Cleaning Validation Manager, Vertex Pharmaceuticals
Cleaning Validation
10:00- 10:40 AM
Select Between Knowledge Exchange Sessions
10:00- 10:40 AM
Fungi and Challenging Contamination
Daniel Klein, Senior Manager Microbiology and Clinical Affairs, STERIS Corporation
Cleanroom Contamination Control
10:00- 10:40 AM
Qualifying Critical Utility Systems
Mike Westerman, VP of CQV and Compliance Services, IPS-Integrated Project Services
Environmental Monitoring
10:00- 10:40 AM
Don’t Miss a Spot! – DocumentationBest Practicesin Cleaning Validation
Christiana Ellis, Cleaning Validation Manager, Vertex Pharmaceuticals
Cleaning Validation
10:45- 11:00 AM
Exhibitor Showroom and Refreshment Break
11:10- 12:00PM
Select Between Knowledge Exchange Sessions
11:10- 12:00PM
Case Study:Annex 1 implementation Strategies
Liz Brockson, Aseptic Processing & Sterility Assurance Lead, Takeda
Cleanroom Contamination Control
11:10- 12:00PM
Automation in Environmental Monitoring
Alexandra Bezilla, Project Manager, Technical Specialist, SherpaPharma
Environmental Monitoring
11:10- 12:00PM
Decode Disinfectants and Cleaning Materials:A Comprehensive Exploration
Dawn Marshall, Global Quality - Site Support, Sanofi
Cleaning Validation
12:00- 1:00PM
Lunch and Learn
1:10- 1:50PM
Select Between Knowledge Exchange Sessions
1:10- 1:50PM
Establish a Contamination Control Strategy
Marsha Steed, Sr. Consultant, JYA and Founder & President, Steed MicroBio LLC Sheba Zaman, Head of Product Specialists and Training Services, Novatek International
Cleanroom Contamination Control
1:10- 1:50PM
Analyzing Environmental Monitoring Data
Arielle Musa, Microbiology Specialist, Johnson & Johnson
Environmental Monitoring
1:10- 1:50PM
Optimizing Spray Coverage andRoutine Monitoring: Insightsfor EnhancedValidation
Sharif Uddin, Ph.D., Principal Engineer Process Cleaning, Rockline Industries
Cleaning Validation
2:00-3:00PM
Select Between Knowledge Exchange Sessions
2:00-3:00PM
Management of ContaminationRisks
Cindy Duhigg, Global Process Validation Steward, Alcon
Cleanroom Contamination Control
2:00-3:00PM
Conduct anAudit of Your Environmental Monitoring Program
Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine
Environmental Monitoring
2:00-3:00PM
AddressingRouge inBiopharmaceutical Manufacturing
TBD
Cleaning Validation
3:10-3:20PM
Exhibitor Showroom and Refreshment Break
3:30-4:10PM
Select Between Knowledge Exchange Sessions
3:30-4:10PM
CurrentRegulatory Inspection and Enforcement Trendsfor Cleaning & Disinfection
Donald Singer, Senior Microbiology Technical Consultant, Ecolab Life Sciences
Cleanroom Contamination Control
3:30-4:10PM
New ASTM Standardsfor Environmental Controls and Monitoring for ATMPs
David W. Vincent MPH, Ph.D, Chief Scientific Officer, VTI Life Sciences
Environmental Monitoring
3:30-4:10PM
ControllingAseptic Simulation (Media Fill) Processes as Part of Your Master Plan
Neal Schmidt MS PMP, Senior Manager of Validation, Resilience
Cleaning Validation
4:20-5:00PM
Select Between Knowledge Exchange Sessions
4:20-5:00PM
4:20-5:00PM
4:20-5:00PM
Cleaning Efficiency:Reduce Costs and Environmental Impact for a Greener Future
Sunil Patel, Regional Leader (South Central), IPS-Integrated Project Services
SPONSORS
Master Cleanroom Contamination Control and Environmental Monitoring: 3-Day Conference in San Diego (40+ Sessions!)
Co-located Event: Cleaning Validation
Elevate your cleanroom and critical cleaning expertise at this comprehensive 3-day conference in San Diego. This co-located event offers over 40 unique sessions, providing in-depth learning opportunities for both cleanroom control and cleaning validation professionals.
Master the latest knowledge and practical skills in from industry experts on:
Cleanroom Qualification & Contamination Control:
- Validation strategies (disinfectant efficacy, Annex 1 compliance)
- Alternative microbiological methods
- Aseptic environment control programs
- Mold & microbial contamination solutions
- Cross-contamination & smoke studies
Environmental Monitoring:
- Designing & optimizing monitoring programs
- Disinfection program qualification
- Environmental monitoring for isolators
- New ASTM standards for ATMPs
- Passivation & derouging monitoring techniques
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Benefits:
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