Schedule
Session Topics
Two tracks over two days, including multiple sessions, dinners, networking drinks, and social events. Customers join early, with customer-exclusive pre-event sessions on Day One.
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Tuesday
November 15
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Wednesday
November 16
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Thursday
November 17
6:00 pm
Reception
Customer Only Reception
8:30 am
REGISTRATION
Registration & Breakfast
Foyer9:00 am
Welcome
Customer Welcome
GM 39:15 am
Session 1
Product Roadmap Round Table
GM 310:15 am
Break
Foyer10:30 am
Session 2
Kneat Gx Version XX Pre-Release Demonstration
GM 311:15 am
Session 3
Process Mapping & Configuration Change Management Best Practices
GM 112:00 pm
New England Comfort Lunch
Rebel's Guild Restaurant12:30 pm
REGISTRATION
General Conference Registration
Foyer1:00 pm
Welcome
Conference Welcome
GM 11:15 pm
Keynote
Conference Keynote: The Ultimate Goal of Quality Data
• The culmination of data across work processes for regulatory submission
• Importance of technology as an enabler or data collection for reporting in the future of quality
• The key metrics for regulatory submission
• The role of data collection, management and control in regulatory submission and audit
2:00 pm
Transition
2:05 pm
Session 1.1
Case Study: Enabling an Industry Disrupting Business Model with Kneat
• Leveraging the efficiency of Digital Validation in a new business model
• Key applications of Kneat to support the model
• Vision, implementation, and results
• Leveraging data in effective computer systems validation
Session 1.2
Enabling AI in GXP systems: Overcoming Challenges & Eliminating Concerns
- Increasing Adoption of AI in GXP systems
- Continuous Learning Models and Change Management
- Managing Bias
2:45 pm
Break
Foyer3:05 pm
Session 2.1
Achieving Data Driven Quality Improvement in Manufacturing
GM 1Session 2.2
Kneat Gx Demonstration
• How Kneat is transforming validation in Life Sciences
• Why Kneat is trusted by Life Sciences industry leaders
• Walkthrough of latest Kneat Gx release
3:50 pm
Transition
3:55 pm
Session 3
Data Integrity and Quality: The Foundations of Actionable Insights
• Difference between Integrity & Quality
• Data Quality core principles
• Applying Data Quality principles to validation data and validation software
4:40 pm
Day 1 Conference Close
GM 15:15 pm
Happy Hour
Lobby Bar5:45 pm
Transportation to Offsite Dinner
Lobby6:00 pm
Boston Harbour Dinner Cruise
TBD9:30 pm
Return to Revere Hotel Boston Common
Lobby8:30 am
Breakfast
Continental Breakfast
Foyer9:00 am
Session 4
Driving Cost Reduction for C&Q Capital Projects with Digital Validation
Driving Cost Reduction for C&Q Capital Projects with Digital Validation
• Measuring and establishing the cost of validation in your C&Q capital project
• Validation’s cost to C&Q capital projects – typical and target ranges
• Applying solutions that drive cost reduction
• Case Study: How Sanofi reduced validation’s cost to C&Q capital projects
9:45 am
Transition
9:50 am
Session 5
Engineering & Quality: Partnering Across the C&Q and Validation Lifecylce
GM 110:30 am
Break
Foyer10:50 am
Session 6.1
Looking into the Future of a Leading Pharma Company: Roadmap and Performance Data
• Understanding the roles of and differences between data and documentation
• Harmonizing validation work processes to enable data driven documentation
• Applying technology to leverage and manage the data
Session 6.2
Creating a Business Case for Your Validation Software Project
• Key inclusions in the business case
• Educating and gaining buy-in from Quality and Engineering Executives
• Position Validation Software against broader QMS solutions
• Demonstating value
11:30 am
Transition
Foyer11:35 am
Session 7.1
Process mapping: How optimized process mapping helps with data integrity and following GEPs
GM 1Communication: Your Key to Project Success
GM 312:15 pm
Taste of Italy Lunch
GM 21:15 pm
Session 8.1
Workshop: Company Operations & Work Processes
GM 18.2
Kneat Best Practices in a FastTrack Program
- What is FastTrack?
- Project kickoff
- Behind the scenes
- Execution best practices
2:00 pm
Transition
Foyer2:05 pm
Session 9.1
Digitizing a Validation Process: Going Beyond 'Paper to Glass'
GM 19.2
Validation Metrics: A Framework for Measurement and Application
• Quality metrics for validation
• Productivity metrics for validation
• Ensuring the effectiveness of your quality and performance metrics
• Finding and applying actionable insights from your validation metrics
2:45 pm
Transition
Foyer2:50 pm
Closing Session
Shifting Focus from Documentation to Data
GM 13:30 pm
Day 2 Conference Close
GM 13:40 pm
Light Refreshments
Foyer9:45 pm
Attendees will hear from leading validation and quality professionals, as well as Kneat and industry experts to expand their understanding of the technologies and best practices to unlock data driven quality. We’re in the final steps of setting the agenda, check back soon for a full list of sessions!