PROCESS VALIDATION &
CONTINUED VERIFICATION

AGENDA

11:00 IST
Detecting the Lack of Data Integrity



12:00 IST
Chairperson’s Opening Remarks



12:15 - 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
Effective Risk-based Decision Making

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



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 Sciences



16:45 IST
Game Night - Trivia Welcome Reception



8:00 IST
Exhibitor Showroom Opens



8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions (1-3)



Validation Audit Preparation

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



Validation Case Study — Using Mixed Reality Technology in C&Q in Equipment and Systems

Donncadh Nagle, Validation Lead, Eirchem Pharma & Researcher, TU Dublin



Create an Effective Supplier Quality Agreement

Elizabeth Rivera, Technical Services Manager, STERIS



9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions (4-7)



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



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 Dublin



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



12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions (8-11)



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 (12-15)



Risk-Based Cleaning Validation – Key Elements for Success

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



lign 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 (16-19)



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

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 (20-22)



The Big Reshuffle – Impact Assessment and System Criticality

Donncadh Nagle, Validation Lead Eirchem; Pharma & Researcher, TU Dublin; Laura Butchart, Validation Lead, ParagonV; Phil Jarvis, Global Commissioning & Qualification Lead (EU), AbbVie



Remote FAT Execution – Best Practices

Alice Redmond, Vice President European Operations, 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 (23-26)



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

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 (27-30)



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 IST
Exhibitor Showroom and Think Tank Sessions



13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions (31-34)



Risk-Based Equipment Qualification

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



The Validation Master Plan (VMP) – Plans that Impress Investigators

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

Matthew LaPierre, Data Integrity Specialist, Industry Expert



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



16:15 – 17:45 IST
Select Between Knowledge Exchange Sessions (35-38)



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

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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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
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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/

Process Validation & Continued Process Verification (CPV)


Attend Virtually!

Process Validation is the backbone of all validation and is always under FDA regulatory scrutiny. KENX is excited to announce the definitive process validation and continued process verification conference of 2020. This event gives you the tools and technology needed to create, deploy and maintain best practices through all three stages of validation. Align with best-in-class case studies that impress FDA investigators and make an immediate impact for your organization and professional career.


Top 10 Reasons to Attend:

  • Walk through a risk-based implementation case study
  • Master the Validation Master Plan (VMP)
  • Establish a compliant Continued Process Verification (CPV) process
  • Uncover the top 5 challenges
  • Leverage technology transfer and engineering studies
  • Discover a Quality by Design (QbD) approach
  • Process Performance Qualification (PPQ) – Select the optimal sampling plan
  • Develop a gap analysis checklist for your program
  • Understand how to use statistics in process validation
  • Learn an effective approach for combination products

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.