Venue: Convene Commerce Square, 2001 Market Street

Hotel: Sonesta Philadelphia Rittenhouse Square









12:00 ET
Exhibitor Showroom and Conference Registration


1:15 ET
Chairperson's Welcome and Opening Remarks


1:30 - 2:10 ET
Opening Session - (Compliance, Operations, Harmonization, Lab Optimization Topics)

Justin Pennington, Ph.D., Assistant Vice President, Merck; 2024 President, Eastern Analytical Symposium; Council of Experts, USP (Invited)

ANALYTICAL


2:10 - 2:50 ET
Using Data Analytics to Effectively Manage the Laboratory

Kayla Woodlief, M.S., Director of Stability and Data Analytics, Vir Biotechnology, Inc

LAB MANAGEMENT


2:50 - 3:30 ET
Streamlining Stability Studies for Clinical Trial Support

Tony Mazzeo, Ph.D., Associate Scientific Director, Product Development - ASO, Stability, Bristol Myers Squibb

STABILITY


3:30 ET
Exhibitor Showroom and Networking Refreshment Break


4:00 - 4:45 ET
"Analytical Procedure Development - The Impact of ICH Q14 Method Development Challenges, Setting Specifications, Method lifecycle, Validation, Transfer of Procedures"

Panelists: Jennifer Lewis, Ph.D., Director, University of Rhode Island; Leanna Pearson, Associate Director of Quality, Compliance, and Quality, CAI; Doug Brown, Ph.D., Stability Manager, Charles River Laboratories; Laura Pack, M.S., Senior Director, CMC Quantitative Science, Moderna; Yan Wu, M.S., Director, Analytical Chemistry in Development and Supply, Merck & Co.

ANALYTICAL PANEL


4:00 - 4:45 ET
Establishing Product Performance - Establish Expiry, Impurity Profiles, Product Lifecycle, OOS Investigation, Sterility/Micro Testing, In-use testing, Excursions

Panelists: Kayla Woodlief, MS, Director of Stability and Data Analytics, Vir Biotechnology, Inc, , Inc; Robert Westney, PA Laboratory Director, FOCUS Laboratories; Tara Scherder, Principal, SynoloStats; Daniel Willingmyre, Associate Director, Stability and Data Analytics, Vir Biotechnology, Inc; Lori McCaig, Ph.D., Director, Global Stability Program Management, Pfizer Inc.

STABILITY PANEL


4:45 ET
Close of Day One and Networking Cocktail Reception


7:30 ET
Exhibitor Showroom and Continental Breakfast


8:00 - 8:40 ET
Select Between Knowledge Exchange Sessions


8:00 - 8:40 ET
Apply ICH Q14 to Analytical Lifecycle Management (ALCM)

Jennifer Lewis, Ph.D., Director, University of Rhode Island

ANALYTICAL


8:00 - 8:40 ET
Securing Compliance - Effective Laboratory Risk Management Strategies Utilizing ICH Q9

Leanna Pearson, Associate Director of Quality, Compliance and Regulatory Affairs, CAI

LAB MANAGEMENT


8:00 - 8:40 ET
Develop, Implement and Maintain a Risk-Based Stability Program

Stephanie Ferrari, M.S., Senior Manager, Global Regulatory Affairs, Vaccines CMC, Pfizer

STABILITY (Temple Track)


8:50 - 9:30 ET
Select Between Knowledge Exchange Sessions


8:50 - 9:30 ET
Connecting ICH Q14 and USP <1220> to Support Analytical Method Lifecycle

Analytical SME, TBD

ANALYTICAL


8:50 - 9:30 ET
Test Method Evaluations - A Risk-based Approach to Identify Opportunities for Improvement

Ron Snee, Ph.D., President, Snee Associates

LAB MANAGEMENT (Temple Track)


8:50 - 9:30 ET
Consideration and Challenges to Develop a Stable Biologic Product

Kelly Forney-Stevens, Ph.D., Associate Director, Drug Product Process & Formulation, Vir Biotechnology

STABILITY


9:30 - 10:30 ET
Speed Training and Networking Refreshment Break


10:30 - 12:00 ET
Select Between Knowledge Exchange Sessions


10:30 - 12:00 ET
Application of Quality-By-Design (QbD) Principles in Analytical Procedure Development According to the New ICH Q14 Guideline

Misty Yeager, Associate Director QA Validation and Engineering, Sarepta Therapeutics

ANALYTICAL


10:30 - 12:00 ET
A Risk-based Approach to AIQ and Method Validation - The Future in Validation for Personalized Medicine

Rob Eleuterio, Senior Manager - Validation, Compliance Group

LAB MANAGEMENT (Temple Track)


10:30 - 12:00 ET
"Focus Topics - A. Data Evaluation and Stability Program Development B. Establish Expiry with Accelerated Development"

Moderators: Laura Pack, M.S., Senior Director, CMC Quantitative Science, Moderna; Lori McCaig, Ph.D., Director, Global Stability Program Management, Pfizer Inc. Tara Scherder, Principal, SynoloStats; Jennifer Lewis, Ph.D., Director, University of Rhode Island; Daniel Willingmyre, Associate Director, Stability and Data Analytics, Vir Biotechnology, Inc

STABILITY HOT TOPICS


12:45 ET
Networking Luncheon


1:30 - 2:10 ET
Select Between Knowledge Exchange Sessions


1:30 - 2:10 ET
Unveiling the Spectrum: Understanding and Categorizing Organic Impurities of Pharmaceutical Products

Kim Huynh-Ba, M.S., FAAPS, Managing Director, Pharmalytik LLC; Adjunct Faculty, RAQA Program, Temple University; Antonio Hernandez-Cardoso, M.S., Senior Principal Scientist, US Pharmacopeia

ANALYTICAL


1:30 - 2:10 ET
Establishing an Investigation Roadmap to Reduce Laboratory Errors

Yan Wu, Director, Analytical Chemistry in Development and Supply, MMD, Merck & Co.

OOS/OOT (Temple Track)


1:30 - 2:10 ET
Evaluation of Stability Data per ICH Q1E: Application of Guidance to Drive Statistical Strategies

Laura Pack, M.S., Senior Director, CMC Quantitative Science, Moderna

STABILITY


2:20 - 3:00 ET
Select Between Knowledge Exchange Sessions


2:20 - 3:00 ET
Setting Acceptance Criteria For Validation

Doug Brown, Ph.D., Stability Manager, Charles River Laboratories

ANALYTICAL (Temple)


2:20 - 3:00 ET
Investigation of Microbiology Out-of-Specification Results

Robert Westney, PA Laboratory Director, FOCUS Laboratories

OOS/OOT


2:20 - 3:00 ET
Stability Beyond ICH: In-Use and Excursion Studies

Kayla Woodlief, MS, Director of Stability and Data Analytics, Vir Biotechnology, Inc; Kelly Forney-Stevens, Director of Formulation Development, Vir Biotechnology, Inc

STABILITY


3:00 ET
Exhibitor Showroom and Networking Refreshment Break


3:30 - 5:00 ET
Select Between Knowledge Exchange Sessions


3:30 - 5:00 ET
Using Statistical Methods to Meet ICH Q14 Requirements

Tara Scherder, Principal, SynoloStats

ANALYTICAL


3:30 - 5:00 ET
Root Cause Analysis - A Systematic Approach

Ron Snee, Ph.D., President, Snee Associates

OOS/OOT (Temple Track)


3:30 - 5:00 ET
"Focus Topics C. Stability Trending, Excursions Studies, In-use Testing D. Data Integrity, Storage, and Electronic Documentation "

Moderators: Kayla Woodlief, MS, Director of Stability and Data Analytics, Vir Biotechnology, Inc; Yan Wu, M.S., Director, Analytical Chemistry in Development and Supply, Merck & Co.; Jing Capucao, Ph.D., Stability Manager, GSK Biopharm Global QC; Leanna Pearson, Associate Director of Quality, Compliance, and Quality, CAI; John O'Neill, PSDG Facilitator, Editor, StabilityHub.com

Stability Hot Topics


5:00 ET
Close of Day Two


7:30 ET
Exhibitor Showroom and Continental Breakfast


8:00 - 8:40 ET
Select Between Knowledge Exchange Sessions


8:00 - 8:40 ET
Critical Activities to Develop Phase Appropriate Method Validation

Jennifer Lewis, Ph.D., Director, University of Rhode Island

ANALYTICAL (Temple)


8:00 - 8:40 ET
Preparation for Laboratory Inspections (Data Integrity, LIMS, Documentation)

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

LAB MANAGEMENT


8:00 - 8:40 ET
Essential Statistics for Stabilitarians

Laura Pack, M.S., Head of CMC Quantitative Science, Moderna

STABILITY


8:50 - 10:20 ET
Select Between Knowledge Exchange Sessions


8:50 - 10:20 ET
Challenges Working with Combination Products such as Pre-filled Syringes and Auto-Injectors

Tom Kelly, Sr QA Manager, Pfizer Inc. (invited)

ANALYTICAL


8:50 - 10:20 ET
The Fundamentals of Data Integrity (DI) in the Lab – How to Modernize your DI Practice

Rick Dursch, Director of Data Integrity and Software Validation, Compliance Group

LAB MANAGEMENT


8:50 - 10:20 ET
Challenges of Using Predictive Stability Concept - Case Studies

Yan Wu, Director, Analytical Chemistry in Development and Supply, MMD, Merck & Co.

STABILITY (Temple Track)


10:30-10:50 ET
Exhibitor Showroom and Continental Breakfast


11:00 - 11:40 ET
Select Between Knowledge Exchange Sessions


11:00 - 11:40 ET
Analytical Method Bridging and Equivalence Testing

Daniel Willingmyre, Associate Director, Stability and Data Analytics, Vir Biotechnology, Inc

ANALYTICAL (Temple Track)


11:00 - 11:40 ET
Critical Factors To Ensure Effectiveness of Microbiology Testing - Focus on the Brain, Body, and Heart

Anthony Grilli, CEO Lab Director, FOCUS Laboratories

LAB MANAGEMENT


11:00 - 11:40 ET
Impact of ICH Q1 (R2) Revision to Current Stability Program

Stability SME, TBD

STABILITY


11:45 - 12:25 ET
Select Between Knowledge Exchange Sessions


11:45 - 12:25 ET
Critical Aspects Of ICH Q14 and How To Develop An Implementation Plan

Leanna Pearson, Associate Director of Quality, Compliance and Regulatory Affairs, CAI

ANALYTICAL


11:45 - 12:25 ET
Navigating Vaccine Stability Challenges - Case Studies

Stephanie Ferrari, MS, Senior Manager, Global Regularoty Affairs, Vaccines CMC, Pfizer

QC EXCELLENCE


11:45 - 12:25 ET
Planes, Trains, and Automobiles-Developing an Effective Protocol for Transportation Studies

Chris Latoz, Manager of Stability Services, Hollister Incorporated

STABILITY (Temple)


12:30 ET
Networking Luncheon


1:30 - 2:10 ET
Select Between Knowledge Exchange Sessions


1:30 - 2:10 ET
Validation and Transfer of Analytical Methods for Biologics

Doug Brown, Ph.D., Stability Manager, Charles River Laboratories

ANALYTICAL (Temple Track)


1:30 - 2:10 ET
Navigating Data Trends: Compliance Challenges and Remediation Strategies

Cody Beaumont, Associate Director Quality Compliant and Regulatory, CAI

QC EXCELLENCE


1:30 - 2:10 ET
Telling the Stability Story - Reporting for Product Teams, Management, and Health Authorities

Lori McCaig, Ph.D., Director, Global Stability Program Management, Pfizer Inc.

STABILITY


2:20 - 3:00 ET
Select Between Knowledge Exchange Sessions


2:20 - 3:00 ET
Navigating Organic Impurities Control Strategies through FDA, ICH, and USP Directives

Kim Huynh-Ba, M.S., FAAPS, Managing Director, Pharmalytik LLC; Adjunct Faculty, RAQA Program, Temple University; Antonio Hernandez-Cardoso, M.S., Senior Principal Scientist, US Pharmacopeia

ANALYTICAL


2:20 - 3:00 ET
Prepare the Stability Area for Regulatory Inspection

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

INSPECTIONS (Temple Track)


2:20 - 3:00 ET
Stability Chambers – An Overlooked but Critically Important Element of the Stability Program

Chris Latoz, Manager of Stability Services, Hollister Incorporated

STABILITY


3:00 ET
Networking Refreshment Break


3:20 - 4:00 ET
Select Between Knowledge Exchange Sessions


3:20 - 4:00 ET
Data Integrity Compliance - Define Your Requirements for Collecting and Evaluating Data

Misty Yeager, Associate Director QA Validation and Engineering, Sarepta Therapeutics

ANALYTICAL


3:20 - 4:00 ET
Conducting a Mock Audit - How to Prepare and Handle FDA Inspections

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

INSPECTIONS (Temple Track)


3:20 - 4:00 ET
Understand Statistical Modelling and Evaluation of Stability Data

Tara Scherder, Principal, SynoloStats

STABILITY


4:10 - 4:50 ET
Select Between Knowledge Exchange Sessions


4:10 - 4:50 ET
Post Conference Summary Report - Emerging Trends and Takeaways

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

SUMMARY


5:30 ET
Close of Conference


Lab Management and QC Excellence

  • Identifying Error By Conducting an Effective Laboratory Investigation
  • Using Data Analytics to Effectively Manage the Laboratory
  • Effectively Handle Stability Deviations and Investigations
  • QC Lab Data Integrity Programs – Development, Implementation and Maintenance
  • Preparation for Laboratory Inspections (data integrity, LIMS, documentation)
  • Data Integrity Compliance – Create Your Custom QC Lab Audit Checklist
  • Use of an integrated Electronic Lab for Maintaining Data Integrity
  • Manage Data Integrity Inspections and Respond to Findings
  • Conducting a Mock Audit – How to Prepare and Handle FDA Inspections

Analytical Method Development & Validation

  • Critical aspects of ICH Q14 and how to develop an implementation plan
  • Using Statistical Methods to Meet ICH Q14 Requirements
  • Analytical Method Bridging and Equivalence Testing
  • Setting acceptance criteria for validation
  • Develop a trending program to monitor organic impurities
  • Validation and transfer of Analytical Methods for Biologics
  • Analytical Instrument Qualification to Support Method Lifecycle
  • Method validations by product Lifecycle Stage – from Phase 1 to Commercial
  • Analytical Method Lifecycle – monitor method performance

Stability Testing & Program Management

  • Challenges of Using Predictive Stability Concept – Case Studies
  • Stability Beyond ICH:  In-Use and Excursion studies
  • Develop, Implement and Maintain a Risk-Based Stability Program
  • Different Approaches to Addressing Cumulative Stability Requirements
  • Effectively Apply Q1E Guidance to Evaluation of Stability Data
  • Developing Change Control Strategies for Stability Program Post-Approval Changes
  • Develop an Effective Protocol for Conducting Transportation Studies
  • Stability Reports:  What to do and how to explain your Stability Data effectively
  • Challenges with Vaccine Stability Program – Case Studies
  • Prepare the Stability Area for Regulatory Inspection
  • Understand Statistical Modelling and Evaluation of Stability Data
  • Stability Chambers Selection, Validation, and Calibration


For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email [email protected], Call 856-281-7134 or Register Above.

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.