12:00 ET
Exhibitor Showroom and Virtual Platform Open House



1:15 ET
Chairman's Opening Remarks



1:30 - 2:15 ET
Laboratory GMPs – A System of Voluntary Compliance Pharmaceutical Laboratory - An FDA Perspective

Gayle Lawson, RPh, Pre-Approval Manager, Office of Pharmaceutical Operations, U.S. FDA (Invited)



2:15 - 3:00 ET
Qualification of Reference Standards

Manju Joshi, Biologist, CBER, U.S. FDA (Invited)



3:00 ET
Exhibitor Showroom and Afternoon Stretch



3:30 - 4:00 ET
Lifecycle Management Concepts to Analytical Procedures - A Compendial Perspective

Amanda Guiraldelli, Ph.D., Scientific Affairs Manager, U.S. Pharmacopeia



3:30 - 4:00 ET
Stability Hall of Shame – Regulations, Guidelines, and Expectations vs. 483’s Warning Letters and Worse

Junghae Scott, Principal, J Scott Consulting



4:00 - 4:30 ET
Creating a Quality Culture - Reduce Human Error and Minimize Risk

Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.



4:00 - 4:30 ET
Modernization of ICH Q1 Standards

Tina Dean, Global Stability Manager, Eli Lilly and Company



4:30 - 5:00 ET
Regulatory Distinctions in Application and Validation of Bioanalytical Methods – These May Not Mean What You Think They Mean….

Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts



4:30 - 5:00 ET
Stability Metrics - Calendars, Clocks, and Scoreboards

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



5:00 ET
Networking Welcome Reception



7:15 ET
Exhibitor Showroom Opens and Lite Breakfast



7:55 - 8:35 ET
Develop a Compliant Test Method Validation (TMV) for Standard Operating Procedures (SOP) and Master Plan

David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences



7:55 - 8:35 ET
Conduct a Gap Analysis in the QC Laboratory

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



7:55 - 8:35 ET
Validation of the Stability-Indicating Profile of a Biological Product – Biologics are Durer’s Rhino

Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts



8:45 - 10:15 ET
Develop a Customized Roadmap for Analytical Procedure Lifecycle

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



8:45 - 10:15 ET
Tips to Reduce and Handle Out of Specification (OOS) / Out of Trend (OOT) Test Results

Junghae Scott, Principal, J Scott Consulting



8:45 - 10:15 ET
Focus Sessions: LIMS – Device & Combination Products – Forced Degradation/Extractables & Leachables

Sheba Zaman, Head of Product Specialists &Training Services, Novatek International; Chris Latoz, Stability Manager, Hollister Incorporated; Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.



8:45 - 10:15 ET
Focus Sessions: Stability Planning – Regulations – CRO’s

Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts



10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break



10:45 - 11:25 ET
System Suitability Tests (SST) and Method Performance Monitoring

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



10:45 - 11:25 ET
Identifying Error By Conducting an Effective Laboratory Investigation

Robert J. Wherry, Principal, White Birch Consulting Services



10:45 - 11:25 ET
Stability Chambers Selection, Validation, and Calibration

Stefan Cazzonelli, Sales and Marketing Manager, Parameter



11:35 - !2:15 ET
Using Risk-based Tools in the Analytical Procedure Lifecycle to Develop and Validate Test Methods

Jane Weitzel, Industry Expert



10:45 - 11:25 ET
Stability Chambers Selection, Validation, and Calibration

Chris Latoz, Stability Manager, Hollister Incorporated



11:35 - 12:15 ET
Managing Method Changes and Revalidation

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



11:35 - 12:15 ET
Documentation Requirements for OOS Investigations

Gary Ritchie, Consultant, CAI



11:35 - 12:15 ET
Chamber Monitoring, Responding to Excursions, Best Maintenance Practices

Chris Latoz, Stability Manager, Hollister Incorporated



12:15 ET
Exhibitor Showroom and Grab & Go Lunch



12:45 - 1:25 ET
Using the Risk-based Tools from the Analytical Procedure Life Cycle to Develop and Validate Test Methods

Jane Weitzel, Industry Expert



12:45 - 1:25 ET
Retesting and Resampling - How Much is Enough

To Be Announced



12:45 - 1:25 ET
Stability Deviations and Out of’s Investigations (OOS/OOT)

Gary Ritchie, Consultant, CAI



1:35 -3:05 ET
Successful Execution of Analytical Method Transfer

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



1:35 -3:05 ET
Validate and Qualify Analytical Instruments to Confirm They Are Fit for Use - Insight form 3 USP Stimuli Articles

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



1:35 -3:05 ET
Focus Sessions: LIMS – Protocols – Sample Handling



3:05 ET
Exhibitor Showroom and Afternoon Stretch



3:30 - 5:00 ET
Validation and Development of Stability Indicating Methods

To Be Announced



3:30 - 5:00 ET
Conducting a Mock Audit - How to Prepare and Handle FDA Inspections

Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.



3:30 - 5:00 ET
Applying Stability Statistics - Staples, Best Practices, and Innovations

Laura Pack, Senior Director, Quality Control & Statistics, Rezolute, Inc.; Lori McCaig, Director, Stability Program Strategy, Seagen, Inc.



5:00 ET
Close of Day Two



7:15 ET
Exhibitor Showroom Opens and Lite Breakfast



7:55 - 8:35 ET
Analytical Method Development Using QbD

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



7:55 - 8:35 ET
AIQ Examples - From Analytical Balances to More Complex Custom-designed Computerized Instruments

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



7:55 - 8:35 ET
PSDG Morning Opener – Virtual Facility Tour, Explore the Stability Landscape & Test Your Conference Knowledge

John O'Neill, PSDG Facilitator, Editor, StabilityHub.com; Alcami (Invited); PPD (Alternate)



8:45 - 10:15 ET
Assay Transfer, Qualification, Validation – Are We Living in a ‘Land of Confusion?

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



8:45 - 10:15 ET
QC Lab Data Integrity Programs - Development, Implementation and Maintenance

David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences



8:45 - 10:15 ET
Stability Focus Topics Wider View: Planning – Regs – CROs – LIMS – Protocols – Sample Handling



10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break



10:45 - 11:25 ET
Continued Method Performance Verification - Control and Reduce Variation and Risk

To Be Announced



10:45 - 11:25 ET
Data Integrity Process Mapping - Identify and Mitigate Data Gaps

Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting



10:45 - 11:25 ET
Stability Function Mapping - Parallels, Intersections, and Dependencies

Walter Routh, Stabilitarian, AbbVie



11:35 - 12:15 ET
System Suitability Tests (SST) and Method Performance Monitoring

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



11:35 - 12:15 ET
Laboratory Records and Notebooks - Compare Notebooks, Worksheets, and Records for Accuracy

Robert J. Wherry, Principal, White Birch Consulting Services



11:35 - 12:15 ET
Setting and Evaluating the Performance of Specifications

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



12:15 ET
Exhibitor Showroom and Grab & Go Lunch



12:45 - 1:25 ET
Using Statistics and Data Trending to Understand Variation

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



12:45 - 1:25 ET
cGMP Training for the QC Scientist - Best Practice and Tips for the QC Scientist

Elizabeth Brockson, MPH - VPH, Associate Director, Global Quality Control, CAI



12:45 - 1:25 ET
Elements of Sample Control-Compliance, Inventory, and Tracking

Sheba Zaman, Head of Product Specialists &Training Services, Novatek International



1:35 - 2:15 ET
Developing Robust HPLC and TOC Methods and Avoiding Common Issues

Michael Lund, Program Manger, Hyde Analytical Laboratory



1:35 - 2:15 ET
Measurements Systems Capability Analysis

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



1:35 - 2:15 ET
Telling the Stability Story – Reporting for Product Teams, Management, and Regulatory Stakeholders

Lori McCaig, Director, Stability Program Strategy, Seagen, Inc.



2:25 - 3:05 ET
Improper Use of Statistics -- The Misuse, Misinterpretation and Bias of Analytical Assay Data

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



2:25 - 3:05 ET
Manufacturing and Shipping Challenges to Stability – Developing a Stability Shelf Life Budget

Lori McCaig, Director, Stability Program Strategy, Seagen, Inc.; Laura Pack, Senior Director, Quality Control & Statistics, Rezolute, Inc.



3:05 ET
Exhibitor Showroom and Afternoon Stretch



3:30 - 4:15 ET
Data Integrity Compliance - Create Your Custom QC Lab Audit Checklist

Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting



3:30 - 4:15 ET
Developing a Stability Budget – Manufacturing and Shipping Challenges to Stability

Walter Routh, Stabilitarian, AbbVie



4:15 ET
Close of Day Three





CAI

CAI













Early Bird Pricing Ends May 13!

0Weeks0Days0Hours

The time has never been greater to stay up-to-speed with current regulatory thinking. Join KENX for Laboratory University and stay up to date with the latest developments and regulations in Analytical Procedures & Methods Validation, Stability Testing & Program Management, and FDA Inspections of Quality Control Laboratories.

Between FDA’s interest in releasing guidance’s the last few years on Analytical Procedures & Methods Validation, Bioanalytical Methods Validation and a flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and each have respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations, but also showcases how leading companies develop methods, validate procedures, and generate data and information that lead to critical business decisions.

Stability testing is critical to the efficacy of drug substances. ICH, FDA and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, industry still has challenges to overcome and seeks more direction. Learn best practices to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators. Laboratory University takes participants through a best practice journey through the development, validation, transfer of analytical methods, stability testing and program management .

Venue: Doubletree by Hilton, Philadelphia

Book Here

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 UNIVERSITY 2022
Main Conference and Inclusive Workshops
$ 2,595.00 $2,595.00
Unlimited
LABORATORY UNIVERSITY 2022 - Team Discount
Main Conference and Inclusive Workshops. Buy 3 Tickets, Get the 4th Free
$ 1,946.25 $1,946.25
Unlimited
LABORATORY UNIVERSITY 2022 - TEMPLE TRACK
Main Conference and Inclusive Workshops - Earn 1.5 Credit Union Hours toward Temple RAQA Program. Additional fee of $995 paid directly to Temple University
$ 2,595.00 $2,595.00
Unlimited

Analytical Procedures & Methods Validation

• Develop a Customized Roadmap for Analytical Procedure Lifecycle Management
• Risk Based Tools for Development and Validation of Test Methods
• Managing Method Changes and Revalidation
• Successful Execution of Analytical Method Transfer
• Validation and Development of Stability Indicating Methods
• Develop an SOP and Master Plan for Method Validation


Stability Testing & Program Management

• Stability Chambers Selection, Validation, and Calibration
• Stone Cold – Biologics, Tissue, Cell and Gene Therapy Stability Practices
• Program Development, Implementation and Management
• Staples of and Best Practices in Applying Stability Statistics
• Elements of Sample Control-Compliance, Inventory, and Tracking
• How Much Does a Stability Study Cost? Developing a Stability Financial Budget


FDA Inspections of Quality Control Laboratories

• Conduct a Gap Analysis in the QC Laboratory
• Tips to Reduce and Handle Out of Specification (OOS) / Out of Trend (OOT) Test Results
• Validation and Qualification of Analytical Instruments, Equipment and Software Platforms
• Development, Implementation and Management of a Data Integrity Program
• Laboratory Management – Critical Elements, Effective Strategies, and Essential Tips for Process Control


Who Should Attend


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

  • Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
  • QA/QC
  • Stability Laboratories
  • Raw Materials
  • Laboratory Management
  • Regulatory Affairs
  • Formulation



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 UNIVERSITY 2022
Main Conference and Inclusive Workshops
$ 2,595.00 $2,595.00
Unlimited
LABORATORY UNIVERSITY 2022 - Team Discount
Main Conference and Inclusive Workshops. Buy 3 Tickets, Get the 4th Free
$ 1,946.25 $1,946.25
Unlimited
LABORATORY UNIVERSITY 2022 - TEMPLE TRACK
Main Conference and Inclusive Workshops - Earn 1.5 Credit Union Hours toward Temple RAQA Program. Additional fee of $995 paid directly to Temple University
$ 2,595.00 $2,595.00
Unlimited