AGENDA
11:00 IST
Detecting the Lack of Data Integrity
12:00 IST
Chairperson’s Opening Remarks
12:15 - 13:15 IST
FDA Insight – Agency Updates and Compliance Trends
James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)
13:15 - 14:00 IST
Effective Risk-based Decision Making
Nuala Calnan, Ph.D., Founder & Principal, BioPharm Excel Ltd.; Adjunct Research Fellow, Technological University Dublin
14:00 IST
Exibitor Showroom and Think Tank Sessions
15:00 - 15:30 IST
Examine Validation Training Effectiveness
Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin
15:30 - 16:00 IST
Detecting the Lack of Data Integrity
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
16:00 - 16:45 IST
FDA’s Proposed Computer Software Assurance Guidance
Kevin Martin, General Manager & Managing Partner, Azzur Group LLC, Senthil Gurumoorthi, Associate Director, and Ken Shitamoto, Senior Director, Gilead Sciences
16:45 IST
Game Night - Trivia Welcome Reception
8:00 IST
Exhibitor Showroom Opens
8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions (1-3)
Validation Audit Preparation
Phil Jarvis, Global C&Q lead for EU, AbbVie
Validation Case Study — Using Mixed Reality Technology in C&Q in Equipment and Systems
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 (4-7)
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
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 Dublin
11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions
12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions (8-11)
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 (12-15)
Risk-Based Cleaning Validation – Key Elements for Success
Chip Bennett, Assistant Director, Global C&Q, CAI
lign 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 (16-19)
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
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 (20-22)
The Big Reshuffle – Impact Assessment and System Criticality
Donnacha Nagle, Validation Consultant & Academic Researcher, TU Dublin; Laura Butchart, Validation Lead, ParagonV; Phil Jarvis, Global Commissioning & Qualification Lead (EU), AbbVie
Remote FAT Execution – Best Practices
Alice Redmond, Vice President European Operations, 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 (23-26)
Lean Validation - Ensure Quality While Reducing Costs
Phil Jarvis, Global C&Q lead for EU, AbbVie; Jerry Quirke, Lead Process Engineer, Kneat Solutions
Qualify Utilities — Water Systems, Clean Steam and Process Gases
David W. Vincent, Ph.D., CEO, VTI Life Sciences
Mapping CQA, CPP, CA – Methodology, Risk Assessment, Sustaining Operations and Change Control
Alice Redmond, Vice President European Operations, 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 (27-30)
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 IST
Exhibitor Showroom and Think Tank Sessions
13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions (31-34)
Risk-Based Equipment Qualification
Chip Bennett, Assistant Director, Global C&Q, CAI
The Validation Master Plan (VMP) – Plans that Impress Investigators
Connie Hetzler, Global Head – Validation, Alcon Laboratories
Computer Software Assurance Master Class
Senthil Gurumoorthi, Associate Director 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 IST
Select Between Knowledge Exchange Sessions (35-38)
Process Validation and Successful Tech Transfer
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
Cleaning Validation – Documents, SOPs and Checklists
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
Right Size Sampling and Statistics for PPQ
Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats
Data Integrity Risk Assessment Across the Data Lifecycle
Valgenesis
17:45 IST
Close of Conference
Process Validation & Continued Process Verification (CPV)
Attend Virtually or In-Person!
Process Validation is the backbone of all validation and is always under FDA regulatory scrutiny. KENX is excited to announce the definitive process validation and continued process verification conference of 2020. This event gives you the tools and technology needed to create, deploy and maintain best practices through all three stages of validation. Align with best-in-class case studies that impress FDA investigators and make an immediate impact for your organization and professional career.
Top 10 Reasons to Attend:
- Walk through a risk-based implementation case study
- Master the Validation Master Plan (VMP)
- Establish a compliant Continued Process Verification (CPV) process
- Uncover the top 5 challenges
- Leverage technology transfer and engineering studies
- Discover a Quality by Design (QbD) approach
- Process Performance Qualification (PPQ) – Select the optimal sampling plan
- Develop a gap analysis checklist for your program
- Understand how to use statistics in process validation
- Learn an effective approach for combination products
Personnel in the Following Environments Should Attend:
- Validation
- QA/QC
- Engineering
- Regulatory Affairs
- Compliance
- Manufacturing
- Laboratory
This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.
