Description
Validation University Europe Compendium
Day 1 (Begins at 12:00 PM)
Using Process Validation Statistics Throughout the Lifecycle
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson
Handouts from the workshop:
Create and Validation GxP Compliant Spreadhseets
Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory Part I
Spreadsheet Design, Verification and Validation, Use and Storage of Single-User Workbook Files in the US FDA Laboratories Part II
Continous Process Verification (CPV) Implementation – An Agile and Compliant Approach Across a Product Portfolio
Rui Almeida, Director, Product Life Cycle Management Services and Maria Ana Batalha, Data Scientist Consultant, Product Life Cycle Management Services, ValGenesis
Day 2 (Begins at 7:15 AM)
Connecting Risk, Knowledge 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; Alice Redmond, Chief Strategy Officer, CAI
Knowledge Management in Validation – Using Technology for Continuous Improvement
Dawn Marshall, Global Quality – Site Support, Sanofi
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
Risk-based Process Validation – Program Implementation Case Study
David W. Vincent, Ph.D. MPH, Chief Scientic Offier, VTI Life Sciences
Using Risk when Making Changes to Validated Systems
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson
Risk-based Supplier Auditing
Alice Redmond, Chief Strategy Officer, CAI
How Digitalization is Shaping the Future of Validation
Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin; Dave O’Connor, C&Q Digital Transformation Manager, No deviation
Validation Processes for Single Use Systems (SUS)
Alice Redmond, Chief Strategy Officer, CAI
Qualifying SaaS, IaaS – Create a Quality Agreement with Cloud Providers
Sachin Bhandari, Head of CSV and Qualification Standards, Boehringer Ingelheim
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
Utility Qualification – HVAC, Water and Process Gases
David W. Vincent, Ph.D. MPH, Chief Scientic Offier, VTI Life Sciences
Day 3 (Begins at 7:15 AM)
Establishing Critical Process Parameters, Acceptance Criteria and Health Limits
Dr. Joe Brady, Lecturer, School of Chemical and BioPharmaceutical Sciences, Technological University Dublin
Leveraging Supplier Activities Including Testing Under CSA
Darren Geaney, Process Engineer, Kneat
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
Cleaning Validation Program Design – A Risk-based Lifecycle Approach
Kenneth Pierce, Ph.D., Technical SME, Cleaning Science & Validation, Hyde Engineering + Consulting
Modernising CSV & CSA Programmes – A Life Cycle Approach
Dr. Joe Brady, Lecturer, School of Chemical and BioPharmaceutical Sciences, Technological University Dublin
CQV QMS – Can Modularity Save Lives?
Paul Bird, Senior QA Director Technical Operations, FUJIFILM Diosynth Biotechnologies; Chris O’Halloran, Digital Validation Services Manager, Veqtor
Continuous Manufacturing Lifecycle Management: An Agile Risk and Data-Driven Framework
Rui Almeida, Director, Product Life Cycle Management Services, ValGenesis
Thinking Critically about Risk Assessments
Stefan Münch, VP Validation & Qualification, Körber Pharma Consulting
Change Control in GxP Environment – Accelerate to Maintain Compliance
Rodrigo Garcia, Senior Global Validation Manager, Boehringer Ingelheim
Cleaning Validation Digitalisation Validation
Parsa Famili, CEO, Novatek International; Laurence O’Leary, Consultant, Event Manager and Owner, ValidEire ApS
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
The Validation Master Plan (VMP) – Plans that Impress Investigators
Connie Hetzler, Global Head – Validation, Alcon Laboratories
Cleaning Cycle Development and Validation Risk-Based Life Cycle Approach
David W. Vincent, Ph.D. MPH, Chief Scientic Offier, VTI Life Sciences
Risk-based Spreadsheet Validation
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson
Using Smoke Studies as a Validation Tool
Jorge Cordero, Validation Manager, Bausch + Lomb
Modernizing Sterilisation Validation Approach with Annex 1
Dr. Joe Brady, Lecturer, School of Chemical and BioPharmaceutical Sciences, Technological University Dublin
Implement a Risk-based Approach to Audit Trail Review
Kim Huynh-ba, Managing Director, Pharmalytik
Data Integrity Risk Management through Process Mapping
Kim Huynh-ba, Managing Director, Pharmalytik
Reduce Cleaning Process Waste: Cleaning Cycle Efficiency and Environmental Footprint – How much Can You Save
Ronald Berk, Chief Technical Officer, Hyde Engineering & Consulting
The Art of Testing – Automated, Scripted, or Unscripted
Stefan Münch, VP Validation & Qualification, Körber Pharma Consulting
Autoclave Validation
Chris Maughan, Sterilization and Thermal Validation, Thermal Compliance, Ltd
Controlling Aseptic Simulation (Media Fill) Processes as Part of Your Master Plan
Jorge Cordero, Validation Manager, Bausch + Lomb
Environmental Monitoring System Design and Validation
Dawn Marshall, Global Quality – Site Support, Sanofi
Temperature Mapping Qualification and Validation
Chris Maughan, Sterilization and Thermal Validation, Thermal Compliance, Ltd.
Cleaning Chemistries for Air Liquid Interface Depositions on Buffer Tanks
Dawn Marshall, Global Quality – Site Support, Sanofi
