EARLY BIRD PRICING ENDS FRIDAY, OCTOBER 27!
AGENDA
12:00:00 CEST
Exhibitor Showroom and Registration Opens
Select Between Inclusive Workshops
13:00 - 17:00 CEST
Using Process Validation Statistics Throughout the Lifecycle
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson
13:00 - 17:00 CEST
Continued Process Verification - Master Ongoing Validation Monitoring
Rui Almeida, Director, Product Life Cycle Management Services and Maria Ana Batalha, Data Scientist Consultant, Product Life Cycle Management, ValGenesis
17:00 CEST
Close of Workshops
7:15 CEST
Exhibitor Showroom Opens and Lite Breakfast
8:15 CEST
Chairpersons Welcome and Opening Remarks
8:30 - 10:00 CEST
ICH Q9 r1 - Implications and Opportunities for QRM, Knowledge Management and Digitalization
Anne Greene, Professor, TU Dublin; Dr. Kevin O'Donnell, Market Compliance Manager, HPRA; Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin
10:00 - 11:00 CEST
Speed Training and Networking - Digital Processes and Innovative Technology
11:00 - 11:30 CEST
Knowledge Management in Validation - Using Technology for Continuous Improvement
Dawn Marshall, Global Quality - Site Support, Sanofi
11:30 - 12:10 CEST
Bridging the Gap Between Annex 1 Revisions and Current Processes - How to Stay Compliant
Jorge Cordero, Validation Manager, Bausch + Lomb; Parsa Famili, CEO, Novatek International, Dawn Marshall, Global Quality - Site Support, Sanofi
12:10 CEST
Round Table Luncheons - Choose Between Annex 11/Part 11, Streamlining Validation, or QbD
13:30 - 14:10 CEST
Risk-based Process Validation - Program Implementation Case Study
David W. Vincent, Ph.D. MPH, Chief Scientic Offier, VTI Life Sciences
13:30 - 14:10 CEST
Equipment Qualification - Mastering IQ/OQ/PQ and Impact Assessments
Connie Hetzler, Global Head – Validation, Alcon Laboratories
13:30 - 14:10 CEST
Risk-based Supplier Auditing
Thanabalan Subramanian, Head of Quality, Integrity Solutions, Inc.
15:00 CEST
Exhibitor Showroom and Networking Break
15:00 - 15:30 CEST
Pharma 5.0 and Validation 5.0 - How Digitalization is Shaping the Future
Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin; Dave O'Connor, C&Q Digital Transformation Manager, No deviation
15:00 - 15:30 CEST
Using Risk when Making Changes to Validated Systems
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson
15:00 - 15:30 CEST
Qualifying SaaS, IaaS - Create a Quality Agreement with Cloud Providers
Sachin Bhandari, Head of CSV and Qualification Standards, Boehringer Ingelheim
15:30 - 17:00 CEST
Improving Risk Based Decision Making - Linking Knowledge, Risk and Decision Making
Anne Greene, Professor, TU Dublin; Valerie Mulholland, Researcher, Pharmaceutical & Regulatory Science Team, TU Dublin, and Principal Consultant, GMP Services; Dr. Marty Lipa, Senior Research Fellow, PRST, TU Dublin; Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin
15:30 - 17:00 CEST
Cleaning Validation Program Design - A Risk-based Lifecycle Approach
Kenneth Pierce, Ph.D., Technical SME, Cleaning Science & Validation, Hyde Engineering + Consulting
15:30 - 17:00 CEST
A Model for Digitalisation Validation
Sachin Bhandari, Head of CSV and Qualification Standards, Boehringer Ingelheim
17:00 CEST
Close of Day One and Networking Cocktail Reception
7:15 CEST
Exhibitor Showroom Opens and Lite Breakfast
7:30 - 8:10 CEST
Validation Processes for Single Use Systems (SUS)
Alice Redmond, Chief Strategy Officer, CAI (Invited)
7:30 - 8:10 CEST
Establishing Critical Process Parameters, Acceptance Criteria and Health Limits
Dr. Joe Brady, Validation Consultant, and Lecturer, TU Dublin
7:30 - 8:10 CEST
Leverage Vendor Testing Under CSA
Mark Geldard, Director Sales EMEA, Kneat
8:20 - 9:00 CEST
Continuous Process Validation and Holistic Control Strategy - Thinking Beyond CPP-Based Critical Aspects
Chip Bennett, Associate Director, Global CQV; SME, CQV Program Development, QRM, CAI
8:20 - 9:00 CEST
Master Risk Tools Used in Validation
Connie Hetzler, Global Head – Validation, Alcon Laboratories
8:20 - 9:00 CEST
Modernising CSV & CSA Programmes - A Life Cycle Approach
Thanabalan Subramanian, Head of Quality, Integrity Solutions, Inc.
9:10 - 9:50
How to Transition to Digital Validation
Paul Bird, Senior QA Director Technical Operations, FUJIFILM Diosynth Biotechnologies; Phil Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor Solutions
9:10 - 9:50
Use Risk throughout the Process Validation Lifecycle
Rui Almeida, Director, Product Life Cycle Management Services, ValGenesis
9:10 - 9:50
How to Critical Thinking to Conduct Risk Assessments
Stefan Münch, VP Validation & Qualification, Körber Pharma Consulting
9:50 - 10:20 CEST
Exhibitor Showroom and Refreshment Break
10:20 - 11:00 CEST
Change Control in Validation – Managing Like-for-Like Changes
Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin
10:20 - 11:00 CEST
Cleaning Validation Digitalisation Validation
Parsa Famili, CEO, Novatek International; Laurence O'Leary, Consultant, Event Manager and Owner, ValidEire ApS
10:20 - 11:00 CEST
How ChatGPT and Superintelligence Platforms Impact Validation of Computerized Systems
Sathish Kumar Shanmugam MS MBA PMP, Product Manager - Qualification and Validation, IIx, Technical Operations - Quality Assurance, F. Hoffmann-La Roche AG
11:10 - 11:50 CEST
The Validation Master Plan (VMP) – Plans that Impress Investigators
Connie Hetzler, Global Head – Validation, Alcon Laboratories
11:10 - 11:50 CEST
Cleaning Validation Optimisation - Facility Waste Reduction
David W. Vincent, Ph.D. MPH, Chief Scientic Offier, VTI Life Sciences
11:10 - 11:50 CEST
Computerised System Validation (CSV) Process Innovation (PI) - Making the Move to Digital Validation
Chris O’Halloran, Digital Validation Services Manager, Veqtor
11:50 -13:00 CEST
Round Table Luncheons - Choose Between Decommissioning, Documentation, AI/ML Qualification
13:00 - 13:40 CEST
Using Smoke Studies as a Validation Tool
Jorge Cordero, Validation Manager, Bausch + Lomb
13:00 - 13:40 CEST
Modernizing Sterilisation Validation Approach with Annex 1
Dr. Joe Brady, Validation Consultant, and Lecturer, TU Dublin
13:00 - 13:40 CEST
Implement a Risk-based Approach to Audit Trail Review
Kim Huynh-ba, Managing Director, Pharmalytik
13:50 - 14:30 CEST
Environmental Monitoring System Design and Validation
Dawn Marshall, Global Quality - Site Support, Sanofi
13:50 - 14:30 CEST
Cleaning Cycle Development and Validation Risk-Based Life Cycle Approach
David W. Vincent, Ph.D. MPH, Chief Scientic Offier, VTI Life Sciences
13:50 - 14:30 CEST
Scripted vs. Unscripted Testing – Requirements Criticality Assessments
"Stefan Münch, VP Validation & Qualification, Körber Pharma Consulting "
14:30 - 14:45 CEST
Exhibitor Showroom and Refreshment Break
14:45 - 15:25 CEST
Autoclave Validation
Chris Maughan, Sterilization and Thermal Validation, Thermal Compliance, Ltd.
14:45 - 15:25 CEST
Strategies to Minimize Cross Contamination
Jorge Cordero, Validation Manager, Bausch + Lomb
14:45 - 15:25 CEST
Data Integrity Risk Management through Process Mapping
Kim Huynh-ba, Managing Director, Pharmalytik
15:35 - 16:15 CEST
Temperature Mapping Qualification and Validation
Chris Maughan, Sterilization and Thermal Validation, Thermal Compliance, Ltd.
15:35 - 16:15 CEST
Cleaning Chemistries for Air Liquid Interface Depositions on Buffer Tanks
Dawn Marshall, Global Quality - Site Support, Sanofi
15:35 - 16:15 CEST
Risk-based Spreadsheet Validation
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson
16:15 CEST
Close of Conference
VALIDATION UNIVERSITY COMES TO AMSTERDAM!
Attend in Amsterdam!
Knowledge Exchange Network (KENX) is extremely excited to announce Validation & GMP University is returning to Europe this November! This is Europe’s leading validation and QMS event. Do not miss this opportunity to network with leading experts and like-minded colleagues leading the charge for best practices in validating processes, cleaning, equipment, facilities, utilities, quality systems & metrics, change control, risk management, inspections and so much more! Participants can create their own experience by choosing from over fifty tutorials and benefit from the wealth of knowledge that will have immediate impact on their professional development and organizations.
Choose from 50 Tutorials Overflowing with Rich Content and Tangible Takeaways, Including:
Process Validation
- Master Risk-based, 3-Stage Process Validation
- How to Drive a Risk-based IQ, OQ, and PQ Approach
- Critical Utility Qualification – HVAC, Water and Process Gasses
Cleaning Validation
- Establish Cleaning Residue Limits and Acceptance Criteria
- Learn How to Validate Visual Inspection Systems
- Hot Topics in Cleaning – Stainless Steel Equipment Maintenance and Air Liquid Interface Rings
Computer System Validation & Software Assurance
- Modernize Software Validation and Risk Assessments
- Tips for Transitioning Current CSV Program to Align with FDA’s Computer Software Assurance Guidance
- Critical Thinking and the CSA Movement – Rethinking Your Approach to Technology
Data Integrity Compliance
- Building and Managing a Data Integrity Program
- Data Process Mapping – Utilize an Innovative Tool to Manage Data Integrity
- Develop a Quality Culture that Minimizes Human Error and Data Integrity Lapses
Quality Metrics & Systems Management
- FDA’s Quality Metrics Movement – What You Need to Know to Get Started
- SOPs – Writing Quality Procedures that Survive the Lifecycle
- How to Increase and Achieve Right First Time Rates
Change Control & Risk Management
- Integrate Risk Management into Change Control Procedures
- Risk-Based Thinking – Maximize your ROI on Risk Assessments – A Practical, Resource Effective Approach to Risk Management
- Conducting Impact Assessments as Part of Change Control
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.
