PROCESS VALIDATION &
CONTINUED VERIFICATION


12:00 ET
Registration and Exhibitor Showroom Openhouse



1:15 ET
Chairman's Opening Remarks



1:15 - 2:15
FDA Compliance Roundtable – Agency Insight, Updates, and Trends

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



2:15 - 2:45 ET
Understanding Human Behavior and Quality Culture in Validation and GMP Operations

Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics, a Nestle Health Sciences Company



2:45 ET
Exhibitor Showroom and Refreshment Break



3:15 - 4:00 ET
Process Validation and Continued Verification — A Risk-based Implementation Case Study

Javier Cardenas, Ph.D., Senior Consultant, Technical Lead, Azzur Group



4:00 - 4:30 ET
Validation Master Plans (VMP), Protocols and Reports - Discover Best in Procedural Templates

JR Humbert, Senior Director Quality, INCOG Biopharma



4:30 - 5:00 ET
Annex 1 Contamination Control — What the Recent Revision Means for Validation

Parsa Famili, President & CEO, NOVATEK INTERNATIONAL



5:00 ET
Game Night - Trivia Welcome Reception





7:30 ET
Exhibitor Showroom and Light Breakfast



8:20 - 9:05
Select Between Knowledge Exchange Sessions (1-4)



1
Conduct a Gap Analysis of Your Validation Program

Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI



2
Supplier Qualification - Create and Maintain Quality Agreements

JR Humbert, Senior Director Quality, INCOG Biopharma



3
Single Use Systems (SUSs) - Implementation and Validation

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



4
Data Integrity Risk Assesements and Process Mapping

Chinmoy Roy, Senior Industry Consultant, ValGenesis



9:15 -10:00 ET
Select Between Knowledge Exchange Sessions (5-8)



5
Supply Chain Validation - Lessons Learned During Covid-19

To Be Announced



6
FDA Inspection Management — Tips that Impress Investigators

Mony Clark, Senior Manager, QA Compliance, Genmark Dx - Roche Diagnostics



7
Align Your CSV Program with FDA’s Proposed CSA Guidance

Joseph Zec, R&D CSV/Process QA and Compliance Leader, Takeda



8
Data Integrity Programs — Case Study Examples

Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting



10:00 ET
Exhibitor Showroom and Refreshment Break



10:00 - 12:00 ET
Select Between Knowledge Exchange Sessions (9-12)



9
Lean Validation — Ensure Quality While Reducing Costs

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



10
Risk-based Cleaning Validation - Key Elements for Success

Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, NOVATEK INTERNATIONAL



11
Critical Thinking and Change Management — Lessons Learned from the CSA Movement

Ken Shitamoto Senior Director, IT Gilead Sciences



12
Data Integrity — Assessment, Implementation, and Maintenance

Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)



12:00 ET
Grab & Go Lunch and Think Tank Sessions



12:30 - 1:00 ET
Select Between Knowledge Exchange Sessions (13-16)



13
Overcome the Top 5 Validation Challenges

Gerardo Gomez, Ph.D., Director QMC-US, Pharmalex



14
Common Gaps in Cleaning Validation and Their Solutions — From Pain to Optimization

TJ Woody, Director of Cleaning Validation, Azzur Group



15
Learn How to Use Effective Risk-based Decision Making in Validation

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



16
Ensure Data Integrity by Design (DIbD) — The Right Data, Right from the Start

Steve Thompson, Director Industry Solutions, ValGenesis



1:30 - 3:00 ET
Select Between Knowledge Exchange Sessions (17-20)



17
Case Study — Implementing a Risk-based Process Validation Life Cycle Approach

Connie Hetzler, Global Head – Validation, Alcon Laboratories (Invited)



18
Process Validation Statistics for Non-statisticians

Alan Golden, MS, Principal, Design Quality Consultants, LLC



19
CSV Hot Topics — SaaS, Spreadsheets, Network Qualification, Clouds, Mobile Technology and Digitalization

Carlos Pereira, Regional Manager of U.S. Midwest and Canada, VTI Life Sciences



20
Cultivate the Culture of Integrity in Data Management

Roque Redondo, VP Automation and Business Development USA Operations, mirus



3:00 ET
Exhibitor Showroom and Refreshment Break



3:30 - 5:00 ET
Select Between Knowledge Exchange Sessions (21 -24)



21
Validation & Verification — A Medical Device Master Class

Melissa Brookshier, Director, Azzur Group



22
Statistical Process Control and The Use Of Control Charts

Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River



23
Take a Risk-based Approach to Audit Trail Reviews

Joseph Zec, R&D CSV/Process QA and Compliance Leader, Takeda



24
Build Your Custom Audit Checklist – Master Class

Mony Clark, Senior Manager, QA Compliance, Genmark Dx - Roche Diagnostics



5:00 ET
Close of Day Two



7:30 ET
Exhibitor Showroom Opens



8:20 - 9:05 ET
Select Between Knowledge Exchange Sessions (25-28)



25
Risk-based Commissioning & Qualification — Successful Development and Execution

Donncha Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin



26
Validation Statistics — Strategies to Graph, Analyze, and Present Data Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Car

Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care



27
Cleaning Validation Hot Topics — Documentation, Acceptance Criteria and Health Limits

Cindy Duhigg, Global Validation Steward, Alcon Laboratories



28
Learn How to Conduct a Mock Inspection in Preparation for an Audit

Eric Henry, Senior Quality Systems and Compliance Advisor, FDA and Life Science Practice, King & Spalding



9:15 - 10:00 ET
Select Between Knowledge Exchange Sessions (29-32)



29
Optimize Process Performance – Implement an Effective Quality Monitoring System

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



30
Conduct Remote Virtual Factory Acceptance Testing (FAT)

Donncha Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin



31
Leverage Digital Validation for Streamlined Risk-Based Testing

Dori Gonzalez-Acevedo, VP of Strategic Solutions, Tx3 Services



32
Learn How to Use Risk in Change Control Processes

Roque Redondo, VP Automation and Business Development USA Operations, mirus



10:00 ET
Exhibitor Showroom and Refreshment Break



10:30 - 12:00 ET
Select Between Knowledge Exchange Sessions (33-36)



33
Critical Utility Qualification and Environmental Monitoring Performance Qualification

Elizabeth Brockson, Associate Director, Global Quality Control, CAI



34
Apply Quality by Design (QbD) for all Validation Types — QbD for All

Steve Thompson, Director Industry Solutions, ValGenesis



35
What to Do When Things Go Wrong — Implement an Effective CAPA Program

Shannon Chesterfield, Senior Director of Consulting, Azzur Group



36
Mastering the Critical Elements of a Quality Risk Management (QRM) Program

Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI



12:00 ET
Grab & Go Lunch and Think Tank Sessions



1:30 - 3:00 ET
Select Between Knowledge Exchange Sessions (37-40)



37
Personnel Training — Hiring People that Make Validation Great

Mark Cheshire, Business Development Manager, H&A Scientific



38
Use Validation Sampling Plans for Critical Decisions

Cindy Duhigg, Global Validation Steward, Alcon Laboratories



39
Analytical Method Validation — What Quality and Process Professionals Need to Know

Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)



40
Change Control - Conduct System Criticality and Impact Assessments

Alan Golden, MS, Principal, Design Quality Consultants, LLC



3:00 ET
Exhibitor Showroom and Refreshment Break



3:15 - 4:45 ET
Select Between Knowledge Exchange Sessions (41-44)



41
Assay Transfer, Qualification, Validation — Are We Living in a ‘Land of Confusion’?

Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River



42
Qualification of Temperature Mapping and Storage Chambers

Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology



43
Statistical Process Control Charts — Analyzing Process Performance

Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River



44
Validation and Change Control — Null Hypothesis Significant Testing

Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care



4:45 ET
Close of Conference









BTR

CAI








Process Validation & Continued Process Verification (CPV)


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 2021. This event gives you the tools and technology needed to create, deploy and maintain best practices through all three stages of validation. Come to this virtual event this spring and 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.


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For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.


Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Tickets are no longer available