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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6:00 pm

Customers
Reception

Customer Only Reception

8:30 am

Customers
REGISTRATION

Registration & Breakfast

Foyer

9:00 am

Customers
Welcome

Customer Welcome

GM 3

9:15 am

Customers
Session 1

Product Roadmap Round Table

GM 3

10:15 am

Customers

Break

Foyer

10:30 am

Customers
Session 2

Kneat Gx Version XX Pre-Release Demonstration

GM 3

11:15 am

Customers
Session 3

Process Mapping & Configuration Change Management Best Practices

GM 1

12:00 pm

Customers

New England Comfort Lunch

Rebel's Guild Restaurant

12:30 pm

REGISTRATION

General Conference Registration

Foyer

1:00 pm

Welcome

Conference Welcome

GM 1

1:15 pm

Validation and Data
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

GM 1

2:00 pm

Transition

2:05 pm

Validation and Data
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

GM 1
Validation and Technology
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
GM 3

2:45 pm

Break

Foyer

3:05 pm

Validation and Data
Session 2.1

Achieving Data Driven Quality Improvement in Manufacturing

GM 1
Validation and Technology
Session 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

GM 1

3:50 pm

Transition

3:55 pm

Validation and Data
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

GM 1

4:40 pm

Day 1 Conference Close

GM 1

5:15 pm

Happy Hour

Lobby Bar

5:45 pm

Transportation to Offsite Dinner

Lobby

6:00 pm

Boston Harbour Dinner Cruise

TBD

9:30 pm

Return to Revere Hotel Boston Common

Lobby

8:30 am

Digital Validation Best Practice
Breakfast

Continental Breakfast

Foyer

9:00 am

Digital Validation Best Practice
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

GM 1

9:45 am

Transition

9:50 am

Digital Validation Best Practice
Session 5

Engineering & Quality: Partnering Across the C&Q and Validation Lifecylce

GM 1

10:30 am

Break

Foyer

10:50 am

Digital Validation Best Practice
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

GM 1
Technology Projects
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

GM 3

11:30 am

Transition

Foyer

11:35 am

Digital Validation Best Practice
Session 7.1

Process mapping:  How optimized process mapping helps with data integrity and following GEPs

GM 1
Technology Projects

Communication: Your Key to Project Success

GM 3

12:15 pm

Taste of Italy Lunch

GM 2

1:15 pm

Digital Validation Best Practice
Session 8.1

Workshop: Company Operations & Work Processes

GM 1
Digital Validation Best Practice
8.2

Kneat Best Practices in a FastTrack Program

  • What is FastTrack?
  • Project kickoff
  • Behind the scenes
  • Execution best practices
GM 3

2:00 pm

Transition

Foyer

2:05 pm

Digital Validation Best Practice
Session 9.1

Digitizing a Validation Process: Going Beyond 'Paper to Glass'

GM 1
Digital Validation Best Practice
9.2

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

GM 1

2:45 pm

Transition

Foyer

2:50 pm

Digital Validation Best Practice
Closing Session

Shifting Focus from Documentation to Data

GM 1

3:30 pm

Day 2 Conference Close

GM 1

3:40 pm

Light Refreshments

Foyer

9:45 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!