STABILITY TESTING &
PROGRAM MANAGEMENT


12:00 PT
Exhibitor Showroom & Virtual Platform Open House



1:00 PT
Chairman’s Opening Remarks



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 & Think Tank Session Reduce Study Risk Through Effective Monitoring Systems



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 PT
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
Handle OOS, OOT & OOE with Confidence and Expertise

Emily Trubee, Quality Control Manger, Stability, Glenmark Pharmaceuticals



8:15 – 9:45 PT
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 & Think Tank Sessions Stability Budgeting - Account for Shelf Life Expenses



10:45 - 12:15 PT
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
Conducting Shipping Studies to Support Product Distribution

Emily Trubee, Quality Control Manger, Stability, Glenmark Pharmaceuticals



1:30 - 2:00 PT
Exhibitor Showroom & Think Tank Sessions Learn the Latest in the World of Photostability



2:15 - 3:00 PT
Stability Budgeting - Account for Shelf Life Expenses

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



3:00 - 3:45 PT
Reference Standard Stability - The Foundation for All Subsequent Stability Studies

John O’Neill, Editor, StabilityHub.com



4:00 - 4:30 PT
Exhibitor Showroom & Think Tank Sessions Common Challenges in Extractables and Leachables Studies



4:45 - 6:15 PT
Shelf Life Determination of Drug Products using ANCOVA and Regression Analysis

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



6:15 PT
Close of Day Two



7:00 PT
Exhibitor Showroom Opens



7:15 - 8:00 PT
Tour a facility, Explore Stability Landscape & Test Your Knowledge

John O’Neill, Editor, StabilityHub.com



8:15 - 9:45 PT
Breakout Topics: Wider View of Chambers, International Regs, CRO’s

Stefan Cassonelli, 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 & Think Tank Sessions Challenge Your Inventory Systems for Maximum Benefit and Minimal Issues

Challenge Your Inventory Systems for Maximum Benefit and Minimal Issues



10:45 - 12:15 PT
Breakout Topics Wider View LIMS, Stats & Reports, Sample Handling

Tina Dean, Technical Manager, Eli Lilly and Company; Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care; Lina Patel, Director, Quality Control, Catalent Cell and Gene Therapy



12:30 - 1:15 PT
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 & Think Tank Sessions Stability Chamber User Design

Applying Statistics to Stability Data



2:15 - 3:00 PT
Determine Which Packaging Factors Are Sufficient for Protecting Your Product Without OverSpending to Over-Protect

Patrick Kelleher, Ph.D., Senior Scientist, Physical Sciences Group, FreeThink Technologies



3:00 - 3:45 PT
Chill with Stability Needs of Vaccines/Biologics/Gene Therapies

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



3:45 - 4:00 PT
Exhibitor Showroom and Refreshment Break



4:00 - 4:45 PT
Stability Requirements for Devices and Combination Products

Chris Latoz, Stability Manager, Hollister Incorporated



4:45 - 5:30 PT
Explore the Power of Leveraging and Equivalence Studies

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



5:30 PT
Close of Conference









CAI








Stability Testing & Program Management Excellence


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. The time has never been more critical to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators.


Stability Leaders Showcase Best-In-Class Programs

  • Discover the ins and outs of Extractables & Leachables
  • Handle OOS, OOT & OOE with confidence and expertise
  • Shelf life determination using ANCOVA & Regression Analysis
  • Stability “Budgeting” for shelf life expenditures prior to sale
  • Explore time window expectations for stability function steps
  • Drug Excipient compatibility studies
  • Establishing stability protocols & review boards
  • Identify Data Integrity gaps in your stability workflow
  • Predict Shelf Life through accelerated testing
  • Packaging factors for protecting your product economically
  • Review Warning Letters & 483’s  related to stability programs
  • Implement stability programs for Biologics & Medical Devices

Personnel in the Following Environments Should Attend:

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

This event is also appropriate to business development and sales managers that offer innovative solutions for QC testing laboratories, data collection, and statistics.

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