Schedule

Session Topics

Two tracks over two days, including 16 sessions, dinners, networking drinks, and social events. Customers join early, with customer-exclusive pre-event sessions on Day One.

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