Validation University

10:30 IST
Exhibitor Showroom and Virtual Platform Open House



11:00 IST
Chairman's Opening Remarks



11:15 - 12:30 IST
Effective Risk-based Decision Making

Nuala Calnan, Ph.D., Founder & Principal, BioPharm Excel Ltd.; Adjunct Research Fellow, Technological University Dublin



12:30 - 13:30 IST
FDA Insight – Agency Updates and Compliance Trends

James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)



13:15 IST
Exibitor Showroom and Think Tank Sessions



14:00 - 14:30 IST
Examine Validation Training Effectiveness

Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin



14:30 - 15:15 IST
Detecting the Lack of Data Integrity

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC



15:30 IST
Exibitor Showroom and Think Tank Sessions



16:15 - 16:45
Assessing GxP SaaS Vendors – Maximize Application Utility, Performance and Compliance

Stephen R Ferrell CISA CRISC CDPSE – Managing Director, CompliancePath



16:45 - 17:30 IST
FDA’s Proposed Computer Software Assurance Guidance

Kevin Martin, General Manager & Managing Partner, Azzur Group LLC, Senthil Gurumoorthi, Director IT, and Ken Shitamoto, Senior Director, Gilead Sciences



17:30 IST
Game Night - Trivia Welcome Reception



8:00 IST
Exhibitor Showroom Opens



8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions



Validation Audit Preparation

Phil Jarvis, Global C&Q lead for EU, Abbvie



Benefits of Verification Activities Using Virtual Reality

Donnacha Nagle; Validation Consultant & Academic Researcher, TU Dublin



Create an Effective Supplier Quality Agreement

Elizabeth Rivera, Technical Services Manager, STERIS



9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions



Implement a Risk-Based Process Validation Programme

Phil Jarvis, Global C&Q lead for EU, Abbvie



Contamination Control Strategy – An Implementation Approach

Walid El Azab, Senior Manager Technical Services, STERIS (invited)



Personnel Training - Hiring People that Make Validation Great

Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex



Build a Change Control Programme from the Gound Up

Alma O’Reilly, Validation Manager, LEO Pharma; Researcher, Technological University Dublin



11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions



12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions



Process Validation Statistics for Non-statisticians

Alan Golden, MS, Principal, Design Quality Consultants, LLC   



Optimize Your Validation Efforts Using QRM

William T. Drummond Jr., MSCS, Senior Director, Global Quality Systems, Charles River Laboratories



Navigate the Maze of Data Integrity Regulations

Roque Redondo, VP Automation & Business Development, Mirus Consulting Group



Build Your Custom Audit Checklist – Master Class

Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi



13:00 - 13:30 IST
Exhibitor Showroom and Think Tank Sessions



13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions



Risk-Based Cleaning Validation – Key Elements for Success

Chip Bennett, Assistant Director, Global C&Q, CAI



Align Your CSV Programme with FDA’s Proposed CSA Guidance

Kevin Martin, Senior Director & Managing Partner, Azzur Group



Cultivate the Culture of Integrity in Data Management

Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC



Learn How to Use Statistics as a Risk Tool

Tara Scherder, Partner, and Katherine Giacoletti, Partner, SynoloStats



15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions



16:15 - 17:45 IST
Select Between Knowledge Exchange Sessions



HANDS-FREE Validation Using Augmented Reality

Steve Thompson, Director Industry Solutions, ValGenesis, Inc.



Validation Statistics with Confidence and The Arts of Charts

Ronald D. Snee, Ph.D., President, Snee Associates, LLC



Manage Data Integrity Inspections and Respond to Findings

Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC



Mastering the Critical Elements of a QRM Programme

Chinmoy Roy, Senior Industry Consultant, Valgenesis



17:45 IST
Close of Day Two



8:00 IST
Exhibitor Showroom Opens



8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions



The Big Reshuffle – Impact Assessment and System Criticality

Laura Butchart, Validation Engineer; Phil Jarvis, Global C&Q lead for EU, Abbvie, Donncadh Nagle, Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals



Remote FAT Execution – Best Practices 

Alice Redmond, Chief Strategy Officer, CAI



Inspection Management – Root Cause Analysis and Corrective Action (CAPA)

Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex



9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions



Lean Validation - Ensure Quality While Reducing Costs

Phil Jarvis, Global C&Q lead for EU, Abbvie; Jerry Quirke, Lead Process Engineer, Kneat Solutions



Commission and Qualification of Clean Utilities

David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences



Mapping CQA, CPP, CA – Methodology, Risk Assessment, Sustaining Operations and Change Control

Alice Redmond, Chief Strategy Officer, CAI



Conduct a Change Control Impact Assessment

Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi



11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions



11:45 - 12:45 IST
Select Between Knowledge Exchange Sessions



Cleaning Validation – Documents, SOPs and Checklists

Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk



Medical Device Validation & Verification Master Class

Alan Golden, MS, Principal, Design Quality Consultants, LLC 



Build a Streamlined Audit Trail Review Process

Matthew LaPierre, Data Integrity Specialist, Industry Expert



Integrate Risk Management into Change Control Processes

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care



13:00 - 13:30
Exhibitor Showroom and Think Tank Sessions

Matthew LaPierre, Data Integrity Specialist, Industry Expert



13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions



Risk-Based Equipment Qualification

Chip Bennett, Assistant Director, Global C&Q, CAI



Use Continuous Monitoring to Reduce Periodic Review Resources 

Connie Hetzler, Global Head – Validation, Alcon Laboratories



Computer Software Assurance Master Class

Senthil Gurumoorthi, Director IT and Ken Shitamoto, Senior Director, Gilead Sciences



Overcome the Top Challenges of Data Integrity Implementation

Matthew LaPierre, Data Integrity Specialist, Industry Expert



15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions



16:15 – 17:45
Select Between Knowledge Exchange Sessions



Process Validation and Successful Tech Transfer

David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences



Create Validation Strategy for Intelligent Automation

Steve Thompson, Director Industry Solutions, ValGenesis, Inc.



Right Size Sampling and Statistics for PPQ

Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats



Data Integrity Risk Assessment Across the Data Lifecycle

Chinmoy Roy, Senior Industry Consultant, VALGENESIS



17:45 IST
Close of Conference







CAI









VALIDATION UNIVERSITY COMES TO DUBLIN – VIRTUALLY!


Attend Virtually!

Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning virtually to Ireland this summer. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create their own experience by choosing from over 50 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate, actionable results.


50 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

 

Commissioning & Qualification

  • Implement a Risk-based Verification Strategy
  • Harness Product and Process Knowledge to Drive a Risk-based IQ, OQ, and PQ Approach
  • Manage a Large CQV Project as Part of a Tech Transfer to an Existing Facility
  • Qualify Temperature Mapping and Storage Chambers

Process Validation

  • Learn How To Use Statistics in Validation – Statistics for Non-Statisticians
  • Implement a 3-Stage Process Validation Approach
  • Master the Validation Master Plan (VMP)
  • Conduct Risk-based Revalidations and Periodic Reviews of Validated Systems

Cleaning Validation

  • Understand Key Elements to a Successful Program
  • Establish Cleaning Residue Limits and Acceptance Criteria
  • Establishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes
  • Receive a Cleaning Validation Assessment Checklist Example

Computer System Validation

  • Cybersecurity – Addressing Malicious Threats to the Life Science Industry
  • Master the Key Components to Build and Maintain an Inspection-proof Program
  • Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services
  • Develop an IT Infrastructure and Network Qualification Roadmap

Data Integrity Compliance

  • Construct a Program from the Ground Up
  • Prepare for and Perform a Data Integrity Audit
  • See Remediation Projects and How to Build for the Future
  • Know How to Respond to Data Integrity Inspection Findings

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.

Pricing & Registration

For special student pricing,

email lisa.benevento@kenx.org or

call 856-308-9777