AGENDA
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
Early Bird Pricing Ends May 13!
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
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
