Validation University

AGENDA

11:00 IST
Exhibitor Showroom and Virtual Platform Open House



12:15 IST
Chairman's Opening Remarks



12:30 - 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
Change Control and Risk Reduction

Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA (Invited)



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 Science



16:45 IST
Game Night - Trivia Welcome Reception



8:00 IST
Exhibitor Showroom Opens



8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions



Validation Audit Preparation

Phil Jarvis, Global C&Q lead for EU, Abbvie



Benefits of Verification Activities Using Virtual Reality

Donncadh Nagle; Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals



Effective Risk-based Decision Making

Nuala Calnan, Ph.D., Founder & Principal, BioPharm Excel Ltd.; Adjunct Research Fellow, Technological University Dublin



Creating an Effective Supplier Quality Agreement

Walid El Azab, Senior Manager Technical Services, STERIS (invited)



9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions



Implement a Risk-Based Process Validation Programme

Phil Jarvis, Global C&Q lead for EU, Abbvie



Contamination Control – GMP and Validation in the Cleanroom

Walid El Azab, Senior Manager Technical Services, STERIS (invited)



Conducting Virtual Audits and Inspections

Alice Redmond, Vice President European Operations, CAI



Change Management and CAPA With a Liberal Dose of Covid

Karen Ginsbury, MSC, BPharm, MRPharms, President and CEO, PCI Pharmaceutical Consulting Israel (Invited)



11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions



12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions



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 Computer Validation Quality Assurance, 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



Risk-Based Cleaning Validation – Key Elements for Success

Chip Bennett, Assistant Director, Global C&Q, CAI



Align 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



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

Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC



17:45 IST
Close of Day Two



8:00 IST
Exhibitor Showroom Opens



8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions



The Big Reshuffle – Impact Assessment and System Criticality

Laura Butchart, Validation Engineer; Phil Jarvis, Global C&Q lead for EU, Abbvie, Donncadh Nagle, Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals



Remote FAT Execution – Best Practices 

Alice Redmond, Vice President European Operations, CAI



Pharma 4.0 – Get that Vision In-Place FAST

Karen Ginsbury, MSC, BPharm, MRPharms, President and CEO, PCI Pharmaceutical Consulting Israel



9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions



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

TBA



11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions



12:45 - 12:45 IST
Select Between Knowledge Exchange Sessions



Create Validation Strategy for Intelligent Automation

Steve Thompson, Director Industry Solutions, ValGenesis, Inc.



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
Exhibitor Showroom and Think Tank Sessions

Matthew LaPierre, Data Integrity Specialist, Industry Expert



13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions



Risk-Based Equipment Qualification

Chip Bennett, Assistant Director, Global C&Q, CAI



Use Continuous Monitoring to Reduce Periodic Review Resources 

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

TBA



15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions



16:15 – 17:45
Select Between Knowledge Exchange Sessions



Process Validation and Successful Tech Transfer

David W. Vincent, Ph.D., CEO, VTI Life Sciences



Cleaning Validation – Documents, SOPs and Checklists

Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats



Right Size Sampling and Statistics for PPQ

Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats



Data Integrity Risk Assessment Across the Data Lifecycle

Chinmoy Roy, Senior Industry Consultant, VALGENESIS



17:45 IST
Close of Conference





SPONSORS



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CAI

Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there. Website: https://commissioningagents.com




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Ellab

Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens. Website: https://www.ellab.com/




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CIMCON Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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Kneat

Kneat Solutions’ feature rich paperless validation platform, KneatGx™ makes validation easier, faster and smarter.  Purpose built for life sciences, KneatGx™ digitizes your entire validation life-cycle, enabling validation teams to author, review, approve, test-execute, manage exceptions and post-approve any business process in a 21 CFR Part 11 compliant web based software that’s securely accessible anywhere with an internet connection.
Website:  www.kneat.com
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Novatek International

Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation. Website: https://ntint.com/
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QACV

QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization. Website: http://www.qacvconsulting.com/

VALIDATION UNIVERSITY COMES TO DUBLIN!


Attend Virtually or in Dublin, Ireland!

Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning 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.