Early Bird Pricing Ends March 22nd, 2024!

Venue:
Sheraton Mission Valley San Diego, 1433 Camino del Rio S, San Diego, CA 92108



CAI









11:55 - 12:00 PM
Start of Day 1


12:00 - 1:00PM PST
Registration - Coffee & Tea


1:00 - 1:15 PM PST
Chairperson's Opening Remarks


1:15 - 2:15 PM PST
Panel: Agency Updates, Compliance Trends, Process Innovation, Digitalization, and the Future of Validation

Moderator: Jonathon Thompson, Director of Product Management, Digital Enablement, CAI; Panelists: Jorge Cordero, Validation Manager, Bausch & Lomb Emily Dickinson MS ASQ CQA, Associate Director of Quality Assurance, Linical Americas Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics


2:15 - 3:00pm PST
Modernize Risk Assessments by Using Critical Thinking

Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group


3:00 - 3:30 PM PST
Networking Refreshment Break and Exhibit Showroom


3:30 - 4:00 PM PST
Validation Knowledge Management - Leverage Technology for ContinuousImprovement

Anthony Manzanares, Solution Engineer, ValGenesis


4:00 - 4:30pm PST
Harness the Power and Understand the Benefits of Using AI in Validation Now

Rosalind Beasley, CEO, Main and Mission, Inc.

RosalindBeasley, CEO, MainandMission,Inc.


4:30 - 5:00 PM PST
TBD

Focus Laboratories



7:00 AM PST
Start of Day 2


7:00 - 8:00 AM PST
Exhibitor Showroom Opens and Lite Breakfast


8:10 - 8:50am PST
Change Control: Using Risk when Making Changes to Validated Systems

Emily Dickinson MS ASQ CQA, Associate Director of Quality Assurance, Linical Americas


8:10 - 8:50am PST
Annex 1 and the Impact on Validation

David Vincent, Chief Scientific Officer, VTI Life Sciences


8:10 - 8:50am PST
Data Tracking and Monitoring the Outputs of Risk Assessments: From Risk to Evidence on a Path Towards Knowledge – A Structured Approach

Rui Almeida, Director – Consultancy Services, Valgenesis


8:50 - 9:40am PST
Refreshment Break, Speed Training & Networking


9:40 - 11:10am PST
Select Between Knowledge Exchange Sessions


9:40 - 11:10am PST
Case Study: Using RiskAcrossthe ProcessValidation Lifecycle - The How, When, Where, and Why Uncovered

Connie Hetzler, Global Validation Head, Alcon


9:40 - 11:10am PST
Mastering Critical Elementsin CleaningValidation

Cindy Duhigg, Global Process Validation Steward, Alcon


9:40 - 11:10am PST
Validation for Digital Threads

Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA (Invited) Daniel Walter, Policy Analyst, CDRH, U.S. FDA (Invited) Jason Spiegler, SVP Strategy & Customer Experience, Compliance Group (Invited)


11:10 - 12:00pm PST
Select Between Knowledge Exchange Sessions


11:10 - 12:00pm PST
Assay Qualification, Validation, Transfer: Are we living in a “Land of Confusion”?

Douglas Brown, Senior Scientist and Manager, Charles River Laboratories


11:10 - 12:00pm PST
Spray Coverage, CleaningValidation, andRoutine Monitoring Equipment Grouping

Alexandra Bezilla, Project Manager, Technical  Specialist, Sherpa Pharma


11:10 - 12:00pm PST
Conduct Risk-based Revalidations and Periodic Reviews of Validated Systems

Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics


12:00- 1:00pm PST
Networking Luncheon


1:00 - 1:40pm PST
Select Between Knowledge Exchange Sessions


1:00 - 1:40pm PST
IQ/OQ/PQ - MasterRisk-based Equipment Qualification

Carlos Gonzalez, SeniorValidation Manager, STEMCELL Technologies


1:00 - 1:40pm PST
Continued Process Verification - Mastering Process Validation Stage 3

Douglas Brown,  Senior Scientist and Manager, Charles River Laboratories


1:00 - 1:40pm PST
Auditing Audit Trails- Your Plan for Success

Joscelyn Bowersock, Senior Director, Quality Assurance  and Regulatory, Precision for Medicine


1:50 - 2:30pm PST
Select Between Knowledge Exchange Sessions


1:50 - 2:30pm PST
Develop an Impressive Validation Master Plan (VMP) for Regulators

Olivia Calder, Process Engineer, Kneat


1:50 - 2:30pm PST
Critical Utility Qualification - HVAC, Water, and Process Gasses

David Vincent, Chief Scientific Officer, VTI Life Sciences


1:50 - 2:30pm PST
Behavioral Change - Secrets to Implementing a Successful Transition from CSV to CSA

Margaret Hindley PhD, CQA, CQE, Director CSA/IT, Taiho Oncology


2:30 - 3:00pm PST
Exhibitor Showroom and Refreshment Break


3:00 - 3:40pm PST
Select Between Knowledge Exchange Sessions


3:00 - 3:40pm PST
Accelerate Process Validation with Data-Based Quality by Design

Alexandra Bezilla, Project  Manager, Technical Specialist,  Sherpa Pharma


3:00 - 3:40pm PST
Using Smoke Studies as a Risk Tool

Carlos Gonzalez, Senior Validation Manager, STEMCELL  Technologies


3:00 - 3:40pm PST
Build a Data Integrity Maturity Model for Compliance

Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting

Cordero,Validation Manager,Bausch&Lomb


3:50 - 4:30pm PST
Select Between Knowledge Exchange Sessions


3:50 - 4:30pm PST
Validation Training -Implementation and Measures of Success

Madhavi Ganesan, Life Sciences Solution Director, KPMG


3:50 - 4:30pm PST
Temperature Mapping Qualification in Controlled Environments

Carlos Gonzalez, SeniorValidation Manager, STEMCELL Technologies


3:50 - 4:30pm PST
The Intersection of GAMP® 5 & CSA - Create a Checklist for Success

Emily Dickinson MS ASQ CQA, Associate Director of Quality Assurance, Linical Americas


4:30 PM PST
End of Day 2


7:30 AM PST
Start of Day 3


7:30 - 8:30am PST
Exhibitor Showroom Opens and Lite Breakfast


8:30 - 9:10 PST
Select Between Knowledge Exchange Sessions


8:30 - 9:10 PST
Implement a Data Infrastructure for Advanced Analytics

Yuk Chun Chiu, CMO, Wheeler Bio


8:30 - 9:10 PST
Conduct an Environmental Monitoring Performance Qualification

Matthew Galley, Director, Commissioning and Qualification, VEQTOR


8:30 - 9:10 PST
Process Validation and Successful Tech Transfer


10:00 - 10:30 PST
Refreshment Break, Speed Training & Networking


10:30 - 11:10 PST
Select Between Knowledge Exchange Sessions


10:30 - 11:10 PST
Validation of Single Use Systems (SUSs)

Yuk Chun Chiu, CMO, Wheeler Bio


10:30 - 11:10 PST
Risk-Based Critical Process Parameters and Quality Attributes (CPP and CQA)

Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics


10:30 - 11:10 PST
Transitioning A Current CSV Program to Align with CSA: A Case Study

Margaret Hindley PhD, CQA, CQE, Director CSA/IT, Taiho Oncology


11:10 - 11:50 PST
Select Between Knowledge Exchange Sessions


11:10 - 11:50 PST
Using Statistics as a Validation Risk Tool

Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson


11:10 - 11:50 PST
Transition from Paper Validation to Digital Platforms

Jonathon Thompson, Director of Product Management, Digital Enablement, CAI


11:10 - 11:50 PST
Validation of AI/ML and Other Superintelligent Platforms

Rosalind Beasley, CEO, Main and Mission, Inc.


12:00 - 1:00 PST
Networking Luncheon -Ask the FDA-Bring Your Compliance Questions

Francisco (Cisco) Vicenty, Case for QualityProgram Manager, U.S. FDA(Invited) Daniel Walter,PolicyAnalyst, CDRH, U.S. FDA( Invited)


1:00 - 1:40 PST
Select Between Knowledge Exchange Sessions


1:00 - 1:40 PST
Qualifying a Facility from the Ground Up - A Map for CQV

David Vincent, Chief Scientific Officer, VTI Life Sciences


1:00 - 1:40 PST
Are You Inspection Ready? Conduct a Gap Analysis of Your Validation Program

Connie Hetzler, Global Validation Head, Alcon


1:00 - 1:40 PST
Creating an Effective Supplier Quality Agreement

Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine


1:50 - 2:30 PST
Select Between Knowledge Exchange Sessions


1:50 - 2:30 PST
Best in Class Documentation - SOPs, Masterplans, and Checklists

Jamie Virnig, Validation Engineer, Exact Sciences


1:50 - 2:30 PST
Construct and Analyze Validation Control Charts

Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson


1:50 - 2:30 PST
Conduct a Change Control Impact Assessment

Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics


2:30 - 2:45 PST
Exhibitor Showroom and Refreshment Break


2:45 - 3:25 PST
Select Between Knowledge Exchange Sessions


2:45 - 3:25 PST
Learn How to Validate Visual Inspection Systems

Matthew Galley, Director, Commissioning and Qualification, VEQTOR


2:45 - 3:25 PST
Analytical Methods Validation for QA and Validation Professionals

Jamie Virnig, Validation Engineer, Exact Sciences


3:35 - 4:15 PST
Select Between Knowledge Exchange Sessions


3:35 - 4:15 PST
Using Process Mapping in Data Integrity Governance

Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group


3:35 - 4:15 PST
Process Validation Statistics for Non-Statisicians

Cindy Duhigg, Global Process Validation Steward, Alcon


5:00pm PST
Close of Day Three


VALIDATION UNIVERSITY IS BACK!

Attend in San Diego!

Validation University is a 3-day conference and training program that provides attendees with the latest knowledge and best practices in validation for the life sciences industry. The conference covers a wide range of topics, including Process Validation, Cleaning Validation, Computer System Validation / Computer Software Assurance, Equipment/Facility Qualification, and critical GMP processes that impact validation. Speakers are industry experts who share their insights and experiences on how to implement effective programs and the conference offers networking opportunities and hands-on, interactive training sessions.

Choose From 45+ Tutorials Overflowing With Rich Content And Tangible Takeaways, Including:

Process Validation

  • Case Study: Using Risk Across the Process Validation Lifecycle – The How, When, Where, and Why Uncovered
  • Process Validation Statistics for Non-statisticians
  • Continued Process Verification – Mastering Process Validation Stage 3
  • Critical Utility Qualification – HVAC, Water, and Process Gasses
  • Accelerate Process Validation with Data-Based Quality by Design
  • Process Validation and Successful Tech Transfer
  • IQ/OQ/PQ – Master Risk-based Equipment Qualification

Cleaning Validation

  • Mastering Critical Elements in Cleaning Validation
  • Spray Coverage, Cleaning Validation, and Routine Monitoring Equipment Grouping
  • Learn How to Validate Visual Inspection Systems

Computer System Validation & Software Assurance

  • Behavioral Change – Secrets to Implementing a Successful Transition from CSV to CSA
  • Transitioning A Current CSV Program to Align with CSA: A Case Study
  • The Intersection of GAMP® 5 & CSA – Create a Checklist for Success
  • Modernize Risk Assessments by Using Critical Thinking

Data Integrity Compliance

  • Build a Data Integrity Maturity Model for Compliance
  • Implement a Data Infrastructure for Advanced Analytics
  • Using Process Mapping in Data Integrity Governance

Quality Metrics & Systems Management

  • Data Tracking and Monitoring the Outputs of Risk Assessments: From Risk to Evidence on a Path Towards Knowledge – A Structured Approach
  • Best in Class Documentation – SOPs, Masterplans, and Checklists
  • Risk-Based Critical Process Parameters and Quality Attributes (CPP and CQA)

Change Control & Risk Management

  • Conduct a Change Control Impact Assessment
  • Construct and Analyze Validation Control Charts
  • Change Control: Using Risk when Making Changes to Validated Systems

Personnel In The Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • C&Q
  • Regulatory and Compliance
  • Facility Management
  • Manufacturing
  • Laboratory

This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.

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