Validation University

AGENDA

10:30 IST

Exhibitor Showroom and Virtual Platform Open House

11:00 IST

Chairman's Opening Remarks

11:15 - 12:30 IST

Effective Risk-based Decision Making

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

12:30 - 13:30 IST

FDA Insight – Agency Updates and Compliance Trends

James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)

13:15 IST

Exibitor Showroom and Think Tank Sessions

14:00 - 14:30 IST

Examine Validation Training Effectiveness

Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin

14:30 - 15:15 IST

Detecting the Lack of Data Integrity

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC

15:30 IST

Exibitor Showroom and Think Tank Sessions

16:15 - 16:45

Assessing GxP SaaS Vendors – Maximize Application Utility, Performance and Compliance

Stephen R Ferrell CISA CRISC CDPSE – Managing Director, CompliancePath

16:45 - 17:30 IST

FDA’s Proposed Computer Software Assurance Guidance

Kevin Martin, General Manager & Managing Partner, Azzur Group LLC, Senthil Gurumoorthi, Director IT, and 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

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

Create an Effective Supplier Quality Agreement

Elizabeth Rivera, Technical Services Manager, STERIS

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 Strategy – An Implementation Approach

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

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; Researcher, Technological University Dublin

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 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

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

Chinmoy Roy, Senior Industry Consultant, Valgenesis

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, Chief Strategy Officer, 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

Lean Validation - Ensure Quality While Reducing Costs

Phil Jarvis, Global C&Q lead for EU, Abbvie; Jerry Quirke, Lead Process Engineer, Kneat Solutions

Commission and Qualification of Clean Utilities

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

Mapping CQA, CPP, CA – Methodology, Risk Assessment, Sustaining Operations and Change Control

Alice Redmond, Chief Strategy Officer, 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

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

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, Director IT 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

Select Between Knowledge Exchange Sessions

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

Chinmoy Roy, Senior Industry Consultant, VALGENESIS

17:45 IST

Close of Conference

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

October 15, 2020/by Chara Kramer

CompliancePath

CompliancePath is a Global IT Regulatory Consulting company with a focus in the Life Sciences and a specialization in the Software Assurance, IT Governance and Data Privacy verticals. Our near shore test centers in Europe and the America’s allow us to deliver Computer and Software Assurance projects in a virtual, risk based and budget conscious manner. We specialize in helping our customers achieve and maintain ISO27001, SOC1/2/3, HITRUST and related certifications. Further, we help software companies in the Life Science commercialize their products, having brought sustainable agile GAMP5 based development processes all the way through product realization. Our 21 CFR Part 11 compliant Life Science platform Promedim, supports clinical trials, GDPR, and remote field service, site inspection and training activities. We are actively involved in GAMP, the Scottish Life Science Association and were signatories on the Turnpike agreement that solidified and increased collaboration between Life Science associations in the UK and US. Website: www.compliancepath.com

July 23, 2020/by rculver

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/

July 23, 2020/by rculver

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/

September 3, 2020/by Chara Kramer

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

July 23, 2020/by rculver

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/

July 23, 2020/by rculver

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/

July 23, 2020/by rculver

VALGENESIS

Global Leader in Paperless Validation Website: http://www.valgenesis.com/

July 23, 2020/by rculver

VTI Life Sciences

Inspiring Operational Excellence through Best-in-Class CQV Processes Website: http://validation.org/

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.