LABORATORY DATA INTEGRITY
COMPLIANCE CONGRESS


12:00 PT
Exhibitor Showroom & Virtual Platform Open House



1:00 PT
Chairman’s Opening Remarks



1:15- 2:00 PT
Analytical Procedure Lifecycle Management / Validation, Verification, and Transfer of Analytical Procedures

Jane Weitzel, USP Council of Experts & Chair of the 2025 General Chapters -Measurement and Data Quality, US Pharmacopeia



2:00- 2:45 PT
Develop a Roadmap for the Lifecycle Management of Analytical Procedures

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



3:00 - 3:30 PT
Exhibitor Showroom & Think Tank Session Ensure Your GMP Lab is Inspection Ready



3:45- 4:30 PT
Data Integrity in the GMP Lab — Overcome Top 5 Challenges

Robert J. Wherry, Principal, White Birch Consulting Services



4:30- 5:15 PT
Creating a Quality Culture

Matthew LaPierre, Data Integrity Lead Consultant, Jackson Scott Consulting



5:30 PT
Game Night - Trivia Welcome Reception



07:00 PT
Exhibitor Showroom Opens



7:15 – 8:00 PT
Select Between Knowledge Exchange Sessions



Analytical
Risk-based Development and Validation of Test Methods

John Long, Ph.D., Director, Bioanalytical Method Development and Validation, Aldevron



Data Integrity
Learn How to Graph and Analyze Data for Decision Making

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



8:15 – 9:45 PT
Select Between Knowledge Exchange Sessions



Analytical
Establish Test Parameters, Conditions and Acceptance Criteria for Analytical Measurements

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



Data Integrity
Rethinking Your Approach to Technology

Matthew LaPierre, Data Integrity Lead Consultant, Jackson Scott Consulting



10:00 - 10:30 PT
Exhibitor Showroom & Think Tank Session Method Variation - Handling Measurement Uncertainty



10:45 – 12:15 PT
Select Between Knowledge Exchange Sessions



Analytical
Case Study – Implementation, Validation and Lifecycle Management of Analytical Procedures

Bette Monnot-Chase, Director, Analytical Sciences, Marinus Pharma



Data Integrity
Identify Root Cause and Implement Corrective Action

Robert J. Wherry, Principal, White Birch Consulting Services



12:30 - 1:15 PT
Select Between Knowledge Exchange Sessions



Analytical
Establish System Suitability and Monitor Method Performance

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



Data Integrity
Data Quality Considerations that Survive the Method Lifecycle

Kevin Walsh, Senior Director, Azzur Labs



1:30 - 2:00 PT
Exhibitor Showroom & Think Tank Session Data Integrity Process Mapping



2:15 – 3:45 PT
Select Between Knowledge Exchange Sessions



Analytical
Validation, Verification, and Transfer of Analytical Methods

John Wass, Director, MSAT and Validation, Xellia (Invited)



Data Integrity
Conquer Data Integrity by Minimizing Human Error

Steve Thompson, Director Industry Solutions, ValGenesis



4:00 - 4:30 PT
Exhibitor Showroom & Think Tank Session Apply QbD Principles to Analytical Procedures



4:45 – 6:15 PT
Select Between Knowledge Exchange Sessions



Analytical
Control N-Nitrosamine Impurities in Pharmaceutical Products

Geoff Carr, Ph.D., Director, Analytical Development, Patheon, part of Thermo Fisher Scientific



Data Integrity
Use Process Mapping to Identify Gaps

Steve Thompson, Director Industry Solutions, ValGenesis



6:15 PT
Close of Day Two



7:00 PT
Exhibitor Showroom Opens



7:15 – 8:00 PT
Select Between Knowledge Exchange Sessions



Analytical
Regression Analysis for Instrument Calibration Curves

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



Data Integrity
Audit Trail Review — Implement Routine Monitoring

Loganathan Kumarasamy, Validation Consultant, Zifo RnD Solutions



8:15 – 9:45 PT
Select Between Knowledge Exchange Sessions



Analytical
Continued Method Performance Verification - An Effective Approach

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



Data Integrity
Manage Data Integrity Inspections and Respond to Findings

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



10:00 - 10:30 PT
T Exhibitor Showroom & Think Tank Session Understand the Human Impact in the QC Laboratory



Challenge Your Inventory Systems for Maximum Benefit and Minimal Issues



10:45 – 12:15 PT
Select Between Knowledge Exchange Sessions



Analytical
Investigate OOS/OOT in Analytical Testing

Erin Thane, Vice President, Azzur Labs



Data Integrity
Selection and Qualification Laboratory Instrumentation — Implement a Risk Assessment and Data Integrity Strategy

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



12:30 - 1:15 PT
Select Between Knowledge Exchange Sessions



Analytical
Documentation and Revalidation Strategies after Method Changes

John Long, Ph.D., Director, Bioanalytical Method Development and Validation, Aldevron



Data Integrity
Develop a Training Program for the QC Scientist

Lina Patel, Director, Quality Control, Catalent Cell and Gene Therapy



1:30 - 2:00 PT
Exhibitor Showroom & Think Tank Session Evaluate Method Validation Factors with Simple Statistical Methods



2:15 – 3:45 PT
Select Between Knowledge Exchange Sessions



Analytical
A Useful Strategy for the Analysis of Dissolution Profiles

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



Data Integrity
Cultivate the Culture of Integrity in Data Management

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



3:45 PT
Afternoon Refreshment Break



4:00 – 5:30 PT
Select Between Knowledge Exchange Sessions



Analytical
Validation and Development of Stability-Indicating Methods

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



Data Integrity
Learn Statistical Methods to Analyze Data of Validation Test Results

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



5:30 PT
Close of Conference









CAI








Recent FDA Warning Letters Highlight Laboratory Data Integrity Deficiencies


Most data integrity non-compliance are cited in the GMP laboratory. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.


Choose From Over 20 Tutorials Addressing Today’s Top Analytical Challenges

 

Laboratory Data Integrity Compliance Congress Highlights Include:

  • Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
  • Conduct a GAP Analysis and Identify Root Causes
  • Conduct an Laboratory DI Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Discover the Impact of Human Behavior
  • Implement Risk Management Protocols, Perform Assessments and Continually Verify
  • Prepare for and Handle FDA DI Investigations
  • Understand Requirements and Handle Audit Trail Reviews

 

Maximize Your Training! This Event is Co-located with Analytical Procedures and Methods Validation:

  • Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • Define and Develop the Content and Scope of Analytical Procedures Program
  • Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • Develop a Roadmap for Analytical Methods Validation
  • Evaluate Characteristics through Statistical Analysis of Validation Data
  • Development and Validation of a Stability-Indicating Analytical Method
  • Learn How to Perform Risk-Based Evaluations
  • Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • Handle the FDA Laboratory Methods Verification Process
  • Effectively Manage Transfer Studies and Protocols

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Scientist
  • Chemist
  • Laboratory Management
  • Regulatory Affairs
  • Data Integrity

This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.


Pricing & Registration

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.
LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS - Main Conference and Inclusive Workshops
Main Conference and Inclusive Workshops
$ 2,595.00
Unlimited
LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS - Team Discount - Register 3 with 4th Free
Team Discount - Register 3, 4th Free. (3x$2595)=$7785 with 4th Free.
$ 1,946.25 $1,946.25
Unlimited
LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS - Temple Track
Temple Track
$ 3,590.00
Unlimited

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.
LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS - Main Conference and Inclusive Workshops
Main Conference and Inclusive Workshops
$ 2,595.00
Unlimited
LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS - Team Discount - Register 3 with 4th Free
Team Discount - Register 3, 4th Free. (3x$2595)=$7785 with 4th Free.
$ 1,946.25 $1,946.25
Unlimited
LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS - Temple Track
Temple Track
$ 3,590.00
Unlimited