AGENDA
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
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 fall. 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.
