LABORATORY UNIVERSITY

11:00 PDT
Exhibitor Showroom and Virtual Platform Open House



12:30 PDT
Chairperson’s Opening Remarks



Analytical & Data Integrity Sessions
USP 1220: A Compendial Perspective

Leonel M. Santos, LMS Consulting, Formerly, Analytical Chemist, Senior Compendial Liaison, and Director of Chemical Medicines at U.S. Pharmacopeia



Lifecycle Management of Analytical Procedure and Methods Validation – FDA Perspective

Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting



Use QbD and DoE Approaches to Produce Robust Methods

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



Stability Sessions
Critical Elements for Stability Program Success

Chris Latoz, Stability Manager, Hollister Incorporated



Audit Preparation and Risk Assessments

John O’Neill, Editor, StabilityHub



Overcome the Challenges of Stability Studies with Combination Products

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



2:30 - 3:00 PDT
Exhibitor Showroom and Think Tank Sessions



Analytical & Data Integrity Sessions
Data Integrity in the QC Lab — Warning Letters and Trends

Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals



Ensure Analytical Procedures and Methods are Fit for Purpose when Data Integrity is Essential

Heather Longden, Snr Marketing Manager and Isabelle VuTrieu, Pharmaceutical Market Development Manager, Waters Corporation



Data Integrity in the Lab – Common Issues and Solutions

Sanjay Agrawal, President and CEO, CIMCON Software



Stability Sessions
The Impact of Excursions and In-Use Conditions

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



The COVID Accelerator Story: Formulation Development to Clinical Manufacturing in Two Months

Libby Russell, PhD, Senior Vice President, Neva Analytics



Shelf-Life Modeling using ASAP (Accelerated Stability Assessment Program)

Kenneth C. Waterman, Ph.D., President, FreeThink Technologies, Inc.



5:00-6:00 PDT
Game Night - Trivia Welcome Reception



7:00 PDT
Exhibitor Showroom Opens



7:15 - 8:00 PDT
Select Between Knowledge Exchange Sessions



Analytical
Implementation of cGMP Training – For the QC Scientist

Maria E. Orpilla, Senior Associate, Quality CMC, Nevakar Inc.



Data Integrity
Data Integrity Compliance Principles

Sheba Zaman, Head of Product Specialists and Training Services, Novatek



Stability
Application of Chemistry to Ensure Forced Degradation Studies are Effective

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



8:15–9:45 PDT
Select Between Knowledge Exchange Sessions



Analytical
Life Cycle Management of Analytical Procedures – A Roadmap

Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP



Data Integrity
The Critical Data Integrity Factor — Human Behavior

Matthew LaPierre, Data Integrity Specialist



Stability
Program Development, Implementation and Maintenance

Emily S. D. Trubee, MS, Stability Manager, Adare Pharmaceuticals



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



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



Analytical
Test Method Validation — Risk Assessments and Mitigation Tools

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



Data Integrity
Building a Corporate Data Integrity Program

Chinmoy Roy, Data Integrity and CSV SME, Industry Consultant, ValGenesis



Stability
Using Quality Risk Management (QRM) to Establish Critical Quality Attributes

Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP



12:30 - 1:15 PDT
Select Between Knowledge Exchange Sessions



Analytical
System Suitability Tests (SST) – Good Analytical Science

Stan Alekman, PhD., Independent Pharmaceutical Consultant, S.L. Alekman Associates, Inc.



Data Integrity
Compliance Strategies for the QC Analyst

John J. Long, Ph.D., Analytical Integrator, Biologics QC, Teva Branded Pharmaceuticals



Stability
Post Approval Change and Stability Testing

Junghae Scott, Principal, J Scott Consulting



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



2:15 - 3:45 PDT
Select Between Knowledge Exchange Sessions



Analytical
Critical Elements for Analytical Method Transfer

Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting



Data Integrity
Create Quality Cultures that Identify and Address Risks

Steve Thompson, Director Industry Solutions, ValGenesis



Stability
Application of Bracketing & Matrixing Designs in Stability Testing

Emily S. D. Trubee, MS, Stability Manager, Adare Pharmaceuticals



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



4:45 - 6:15 PDT
Select Between Knowledge Exchange Sessions



Analytical / Stability
Validation of Stability-Indicating Analytical Methods

Commissioning Agents, Inc. (CAI)



Data Integrity
QC Audit Trails — Documents, Reports and Reviews

Sheba Zaman, Head of Product Specialists and Training Services, Novatek



Stability
Statistics in Stability Studies – Evaluating Data

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



6:15 PDT
Close of Day Two



7:00 PDT
Exhibitor Showroom Opens



Exhibitor Showroom Opens
Select Between Knowledge Exchange Sessions



Analytical
Determine Calibration Curves Using Regression Analysis

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



Data Integrity
Keeping Data Integrity in Mind While Qualifying Instruments

Heather Longden, Senior Marketing Manager, Waters Corporation



Stability
Building Effective and Efficient Stability Protocols

John O’Neill, Editor, StabilityHub



8:15 - 9:45 PDT
Select Between Knowledge Exchange Sessions



Analytical
OOS/OOT Investigations for Analytical Testing and Stability Studies

Junghae Scott, Principal, J Scott Consulting



Stability
Support and Elevate Your Stability Program with Computerized Tools

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



Data Integrity
Understanding Data Pedigree to Assess Data Integrity and Quality Data Risk

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



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



10:45 - 12:15 PDT
Select Between Knowledge Exchange Sessions



Analytical
Verification of Compendial Methods

John J. Long, Ph.D., Analytical Integrator, Biologics QC, Teva Branded Pharmaceuticals



Data Integrity
Data Integrity Process Mapping

Matthew LaPierre, Data Integrity Specialist



Stability
Implement Control Strategies to Monitoring Impurities through Pharmaceutical Development

Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP



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



Analytical
System Suitability Establishment in and risk management Purity Methods for Protein Analysis

Liang Jia, Senior Manager, CMC Analytical, NGM Biopharmaceuticals



Data Integrity
How to Prepare for & Handle Laboratory Inspections

Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals



Stability
Use of Accelerated Stability Modeling in Regulatory Filings

Kenneth C. Waterman, Ph.D., President, FreeThink Technologies, Inc.



2:15 - 3:45 PDT
Select Between Knowledge Exchange Sessions



Analytical
Root Cause Investigation to Overcome Analytical Method Transfer (AMT) and Validation (AMV) Challenges

Yasaman Bahreini, Validation and QA senior Consultant, Azzur Group



Data Integrity
Conduct a Data Integrity Audit and Gap Assessment

Steve Thompson, Director Industry Solutions, ValGenesis



Stability
Using Statistics for Process Capability, Stability and Control

Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc.



4:00 - 5:30 PDT
Select Between Knowledge Exchange Sessions



Analytical
Improper Use of Statistics – The Misuse, Misinterpretation and Bias of Analytical Assay Data

Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc



Data Integrity
Lab Data Integrity Case Studies – Program Implement and Overcoming Challenges

Alexander Margulis, Ph.D., Senior Director, Azzur Labs



Stability
Introduction to Medical Device Stability Testing

Chris Latoz, Stability Manager, Hollister Incorporated



5:30 PDT
Close of Conference






CAI





TEMPLE ON-DEMAND

Presented by:

Earn 1.5 credit unit hours by registering for this course!


By taking this on-demand course, you’ll be able to earn 1.5 credit unit hours.  Once registered, KENX will send your log-in to our virtual conference which contains the designated Temple University sessions. 

Take every designated Temple session on your time, the schedule is completely up to you!

You can also earn credits through our other courses such as Computer Systems Validation and Data Integrity Compliance Congress and Validation & GMP University.


Laboratory University


Laboratory University contains 3 amazing events all in one!


Analytical Procedures & Methods Validation

  • Life Cycle Management and Training Implementation
  • Risk-Based Test Method Validation
  • Analytical Transfer and Comparability Studies
  • Method Variation – Handling Measurement Uncertainty
  • Stability-Indicating Analytical Methods
  • Criteria for System Suitability Testing Limits

Stability Testing & Program Management

  • Risk Management and Critical Quality Attributes
  • Forced Degradation and Reduced Study Designs
  • Program Development, Implementation and Management
  • OOS and OOT Investigations for Analytical Testing
  • In-Use and Excursions – Stability beyond ICH
  • Process Capability, Stability and Control

Laboratory Data Integrity Compliance Congress

  • Building a Program from the Ground Up
  • Good Documentation Practices
  • Human Error Reduction Strategies
  • Risk Assessments – Using Process Flow Charts
  • Quality Cultures that Identify and Address Risks
  • Streamline Compliance Across Paper, Electronic and Hybrid Systems

…and so much more!

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.