Validation & GMP University


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







CAI












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.


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