AGENDA
11:00 IST
Exhibitor Showroom and Virtual Platform Open House
11:30 IST
Chairman's Opening Remarks
11:45 - 12:15 IST
Effective Risk-based Decision Making
Nuala Calnan, Ph.D., Founder & Principal, BioPharm Excel Ltd.; Adjunct Research Fellow, Technological University Dublin
12:15 - 12:45 IST
FDA Insight – Agency Updates and Compliance Trends
James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)
12:45 - 13:15 IST
Validation Audit Preparation
Phil Jarvis, Global C&Q lead for EU, AbbVie
13:15 IST
Exhibitor Showroom and Afternoon Stretch
13:20 IST -13:40 IST
Think Tank: Traceability
13:45 - 14:15 IST
Examine Validation Training Effectiveness
Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin
14:15 - 14:45 IST
Detecting the Lack of Data Integrity
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
14:45 - 15:15 IST
Remote FAT Execution – Best Practices
Alice Redmond, Vice President European Operations, CAI
15:15 IST
Exhibitor Showroom and Afternoon Stretch
15:45 - 16:15 IST
Assessing GxP SaaS Vendors — Maximize Application Utility, Performance and Compliance
Stephen R. Ferrell, CISA CRISC CDPSE – Managing Director, CompliancePath
16:15 - 16:45 IST
Annex 1 Contamination Control -What the Recent Revision Means for Validation
Parsa Famili, President and CEO, NOVATEK INTERNATIONAL
16:45 - 17:30 IST
FDA’s Proposed Computer Software Assurance Guidance
Kevin Martin, General Manager & Managing Partner, Azzur Group LLC, 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 (1-2)
1
Emerging Technologies in the Pharma and Life Sciences Industry – Mixed Reality Case Study
2
Create an Effective Supplier Quality Agreement
Elizabeth Rivera, Technical Services Manager, STERIS
9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions (3-5)
Donncadh Nagle, CQV Lead, Jacobs Engineering Group; & Researcher, TU Dublin; Michael Egan, Lead Validation Engineer I, Alkermes Pharma Ireland
3
Implement a Risk-Based Process Validation Programme
Phil Jarvis, Global C&Q lead for EU, Abbvie
4
Contamination Control Strategy – An Implementation Approach
Walid El Azab, Senior Manager Technical Services, STERIS (invited)
5
Mapping CQA, CPP, CA – Methodology, Risk Assessment, Sustaining Operations and Change Control
Alice Redmond, Vice President European Operations, CAI
11:10 - 11:50 IST
Exhibitor Showroom and Think Tank Sessions
Wired vs. Wireless - Risk and Benefits of Thermal Validation
Dennis Plante, Senior Validation Market / Product Manager, Amphenol - Kaye
Personnel Training - Hiring People that Make Validation Great
Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex
12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions (8-10)
8
Process Validation Statistics for Non-statisticians
Alan Golden, MS, Principal, Design Quality Consultants, LLC
9
Optimize Your Validation Efforts Using QRM
William T. Drummond Jr., MSCS, Senior Director, Global Quality Systems, Charles River Laboratories
10
Navigate the Maze of Data Integrity Regulations
Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
12:55 - 13:15 IST
Exhibitor Showroom and Think Tank Sessions
Build Your Custom Audit Checklist – Master Class
Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
Align Your CSV Programme with FDA’s Proposed CSA Guidance
Kevin Martin, Senior Director & Managing Partner, Azzur Group
13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions (13-15)
13
Risk-Based Cleaning Validation – Applying CQAs and CPPs Throughout the Cleaning Process Validation Lifecycle
Chip Bennett, Assistant Director, Global C&Q, CAI
14
Cultivate the Culture of Integrity in Data Management
Peju Odunusi, Ph.D. Director, Analytical Sciences, Gossamer Bio
15
Learn How to Use Statistics as a Risk Tool
Tara Scherder, Partner, and Katherine Giacoletti, Partner, SynoloStats
15:25 - 16:05 IST
Exhibitor Showroom and Think Tank Sessions
HANDS-FREE Validation Using Augmented Reality
Steve Thompson, Director Industry Solutions, ValGenesis, Inc.
Inspection Management – Root Cause Analysis and Corrective Action (CAPA)
Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex
16:15 - 17:45 IST
Select Between Knowledge Exchange Sessions (18-20)
18
Validation Statistics with Confidence and The Arts of Charts
Ronald D. Snee, Ph.D., President, Snee Associates, LLC
19
Manage Data Integrity Inspections and Respond to Findings
Peju Odunusi, Director, Analytical Sciences, Gossamer Bio
20
Mastering the Critical Elements of a QRM Programme
Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
17:45 IST
Close of Day Two
8:00 IST
Exhibitor Showroom Opens
8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions (21-22)
21
The Big Reshuffle – Impact Assessment and System Criticality
Laura Butchart, Validation Lead, ParagonV;; Phil Jarvis, Global C&Q lead for EU, Abbvie, Donncadh Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin
22
Conduct a Change Control Impact Assessment
Dawn Marshall, Senior Director and Sterility Assurance SME, Sanof
9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions (23-25)
23
Lean Validation - Ensure Quality While Reducing Costs
Phil Jarvis, Global C&Q lead for EU, Abbvie; Jerry Quirke, Lead Process Engineer, Kneat Solutions
24
Qualify Utilities – Water Systems, Clean Steam and Process Gases
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
25
Advanced Cleaning Validation – How Much Validation is Enough and Green Your Clean
Dr. Kenneth Pierce, Cleaning Validation SME, Hyde Engineering + Consulting
11:10 - 11:50 IST
Exhibitor Showroom and Think Tank Sessions
Legacy Software Applications and Spreadsheets - Data Integrity and Compliance
Sanjay Agrawal, President and CEO, CIMCON Software, LLC
Data Integrity & Compliance for your Legacy Software Applications and Spreadsheets
Sanjay Agrawal, President and CEO, CIMCON Software
Build a Streamlined Audit Trail Review Process
Matthew LaPierre, Data Integrity Specialist, Industry Expert
12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions (28-30)
28
Cleaning Validation – Documents, SOPs and Checklists
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
29
Create Validation Strategy for Intelligent Automation
Steve Thompson, Director Industry Solutions, ValGenesis, Inc.
30
Integrate Risk Management into Change Control Processes
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
12:55 - 13:35
Exhibitor Showroom and Think Tank Sessions
Equipment Qualification — A Risk-based Approach to Ensure Fit for Intended Use
Chip Bennett, Assistant Director, Global C&Q, CAI
Overcome the Top Challenges of Data Integrity Implementation
Matthew LaPierre, Data Integrity Specialist, Industry Expert
13:45 – 15:15 IST
Select Between Knowledge Exchange Sessions (33-35)
33
Process Validation and Successful Tech Transfer
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
34
The Validation Master Plan (VMP) – Plans that Impress Investigators
Connie Hetzler, Global Head – Validation, Alcon Laboratories
35
Computer Software Assurance Master Class
Ken Shitamoto, Senior Director, Gilead Sciences
15:30 - 15:45 IST
Exhibitor Showroom and Afternoon Stretch
15:45 - 17:15 IST
Select Between Knowledge Exchange Sessions (36-38)
36
Medical Device Validation & Verification Master Class
Alan Golden, MS, Principal, Design Quality Consultants, LLC
37
Right Size Sampling and Statistics for PPQ
Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats
38
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.
