LABORATORY UNIVERSITY


11:00 PT
Exhibitor Showroom and Virtual Platform Open House



1:00 PT
Chairman's Opening Remarks



ANALYTICAL & DATA INTEGRITY SESSIONS



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

Horacio N. Pappa, CQE, Ph.D., Director – General Chapters, Global Science and Standards Division, U.S. Pharmacopeia



2:00 - 2:45 PT
Prepare and Handle FDA Inspections — Ensure Your GMP Lab is Inspection Ready

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



STABILITY SESSIONS



1:15 - 1:45 PT
Learn about PSDG and Stability News from Other Meetings

John O'Neill, PSDG Facilitator, Editor, StabilityHub.com



1:45 - 2:15 PT
Here’s the 411 on Stability Program 483s and Warning Letters!

Chris Latoz, Stability Manager, Hollister Incorporated



2:15 - 2:45 PT
Identify Data Integrity Gaps in Your Stability Workflow

Sheba Zaman, Head of Product Specialists &Training Services, NOVATEK INTERNATIONAL



3:00 - 3:30 PT
Exhibitor Showroom and Think Tank Sessions



Ensure Your GMP Lab is Inspection Ready



Reduce Study Risk through Effective Monitoring Systems



ANALYTICAL & DATA INTEGRITY SESSIONS



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



STABILITY SESSIONS



3:45 - 4:30 PT
Advanced Modeling from Accelerated Stability Testing (ASAP) to Determine Drug Product Shelf-life - Fundamentals and Case Studies

Kristina Flavier, Ph.D., Senior Scientist, Physical Sciences Group, FreeThink Technologies



4:30 - 5:15 PDT
Explore Time Window Expectations for Stability Function Steps

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



5:30 PT
Game Night - Trivia Welcome Reception



7:00 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



Stability
Handle OOS, OOT & OOE with Confidence and Expertise

Emily Trubee, Quality Control Manger, Stability, Glenmark Pharmaceuticals



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



Stability
Breakout Sessions - Stability Chambers, Intenational Regs, CRO's

Stefan Cazzonelli, Sales and Marketing Manager, Parameter Loren "Lonnie" Stuckert, Associate Researcher, Procter & Gamble Bette Monnot-Chase, Director, Analytical Sciences, Marinus Pharma



10:00 -10:30 PT
Exhibitor Showroom and Think Tank Sessions



Method Variation — Handling Measurement Uncertainty



Stability Budgeting — Account for Shelf Life Expenses



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



Analytical
Implementation of 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



Stability
Breakout Sessions: LIMS, Stats & Reports, Sample Handling

Tina Dean, Technical Manager, Eli Lilly and Company Lina Patel, Director, Quality Control, Catalent Cell and Gene Therapy



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



Stability
Conducting Shipping Studies to Support Product Distribution

Emily Trubee, Quality Control Manger, Stability, Glenmark Pharmaceuticals



1:30 – 2:00 PT
Exhibitor Showroom and Think Tank Sessions



Data Integrity Process Mapping



Learn the Latest in the World of Photostability



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



Stability
Establish Stability Protocols and Review Boards

John O'Neill, Editor, StabilityHub.com



Stability
Reference Standard Qualification — Ensure Integrity in Stability Studies

John O'Neill, Editor, StabilityHub.com



4:00 - 4:30 PT
Exhibitor Showroom and Think Tank Sessions



Apply QbD Principles to Analytical Procedures



Common Challenges in Extractables and Leachables Studies



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



Stability
Shelf Life Determination of Drug Products using ANCOVA and Regression Analysis

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



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 Engineer, Johnson & Johnson Vision Care



Data Integrity
Audit Trail Review — Implement Routine Monitoring

Loganathan Kumarasamy, Head – US Validation & Compliance Services, Zifo RnD Solutions



Stability
Tour a Facility, Explore Stability Landscape & Test Your Knowledge

John O'Neill, PSDG Facilitator, Editor, StabilityHub.com



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



Stability
Breakout Topics: Wider View of Chambers, International Regs, CRO's

Stefan Cazzonelli, Sales and Marketing Manager, Parameter Loren "Lonnie" Stuckert, Associate Researcher, Procter & Gamble Bette Monnot-Chase, Director, Analytical Sciences, Marinus Pharma



10:00 - 10:30 PT
Exhibitor Showroom and Think Tank Sessions



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



Stability
Breakout Topics Wider View LIMS, Stats & Reports, Sample Handling

Tina Dean, Technical Manager, Eli Lilly and Company Lina Patel, Director, Quality Control, Catalent Cell and Gene Therapy



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



Stability
Conduct Drug Excipient Compatibility Studies — A Case Study

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



1:30 - 2:00 PT
Exhibitor Showroom and Think Tank SessionsExhibitor Showroom and Think Tank Sessions



Evaluate Method Validation Factors with Simple Statistical Methods



Stability Chamber User Design



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



Stability
Determine Which Packaging Factors Are Sufficient for Protecting Your Product Without Over-Spending to Over-Protect

Patrick Kelleher, Senior Scientist, Physical Sciences Group, FreeThink Technologies



Stability
Chill with Stability Needs of Vaccines/Biologics/Gene Therapies

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



4:00 - 5:30 PDT
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



Stability
Stability Requirements for Devices and Combination Produc

Chris Latoz, Stability Manager, Hollister Incorporated



Stability
Explore the Power of Leveraging and Equivalence Studies

Lori McCaig, Director, Stability Program Strategy, Seagan (Invited)



5:30 PT
Close of Conference









CAI








Laboratory University


Laboratory University contains 3 amazing events at one location! Create your own event by choosing from over 40 knowledge exchanges tutorials, including:


LABORATORY UNIVERSITY: HYBRID CONFERENCE

Attend Virtually 

June 22-24, 2021

Special Rate: $1,995/person

Laboratory University Agenda At A Glance: https://kenx.org/wp-content/uploads/2021/05/042921-LabU-AAAG.pdf

Stability Testing and Program Management Brochure: https://kenx.org/wp-content/uploads/2021/05/042721-Lab-U-BB-Stability.pdf

Analytical Procedures & Methods Validation/Laboratory Data Integrity Compliance Congress Brochure: https://kenx.org/wp-content/uploads/2021/05/Lab-U-BB-042921-AMDI.pdf

Registration Form