LABORATORY UNIVERSITY

AGENDA

12:00 PM
Conference Registration

Coffee and Lite Snacks On-the-Go



1:15 PM
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



3:00 PM
Afternoon Refreshment Break



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, CIMINFO Software



Stability Sessions
The Impact of Excursions and In-Use Conditions

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



Post Approval Change and Stability Testing

Junghae Scott, Principal, J Scott Consulting



Use of Accelerated Stability Modeling in Regulatory Filings

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



5:00 PM
KENX / Temple Scholarship Award & Welcome Reception



7:00 AM
Coffee and Lite Breakfast



7:30 - 8:15 AM
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



8:30 - 10:00 AM
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 AM
Networking Refreshment Break



10:30 AM - 12:00 PM
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
QC Lab Data Integrity Program Best Practice

Chris Wubbolt, Principal, QACV



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



12:00 PM
Focus Group Luncheons



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



1:15 – 2:45 PM
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



2:45 PM
Afternoon Refreshment Break



3:15 – 4:45 PM
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



7:00 AM
Coffee and Lite Breakfast



7:30 – 8:15 AM
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



8:30 – 10:00 AM
Select Between Knowledge Exchange Sessions



Analytical
OOS/OOT Investigations for Analytical Testing and Stability Studies

Junghae Scott, Principal, J Scott Consulting



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 AM
Mid-Morning Refreshment Break



10:30 AM – 12:00 PM
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



12:00 PM
Focus Group Luncheons



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

Patrick Kelleher, Senior Scientist, Physical Sciences Group, FreeThink Technologies



1:15 – 2:45 PM
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.



2:45 PM
Afternoon Refreshment Break



3:15 – 4:45 PM
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
Implementing a Data Integrity Program from the Ground Up

Azzur Group



Stability
Introduction to Medical Device Stability Testing

Chris Latoz, Stability Manager, Hollister Incorporated



4:45 PM
Close of Conference



SPONSORS




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Azzur Group

A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive. Website: https://www.azzur.com/
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CAI

Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there. Website: https://commissioningagents.com
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Ellab

Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens. Website: https://www.ellab.com/




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CIMINFO Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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H&A Scientific

H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program. Website: http://www.hascientific.com/en/
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Neva Analytics

Neva Analytics provides contract analytical services to the pharmaceutical and biotech industries. Our laboratory works with pharmaceutical companies and compounding pharmacies during all stages of development to help bring their products to market. We provide custom analytical services tailored to our client's needs. Founded on over 20 years of pharmaceutical industry experience, we know what it takes to develop methods, test and release your product. Your time is valuable so we pride ourselves on quickly responding to your analytical needs. We set the standard for quickly responding to our client’s requests and providing the highest quality results so our clients can advance critical therapies. Website: http://nevaanalytics.com/
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Novatek International

Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation. Website: https://ntint.com/
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QACV

QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization. Website: http://www.qacvconsulting.com/
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Waters Corporation

From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions. Waters Corporation is the world's leading specialty measurement company focused on improving human health and well being through the application of advanced analytical science technologies. Website: http://www.waters.com

Laboratory University


Laboratory University contains 3 amazing events at one location! Create your own event by choosing from over 40 knowledge exchanges tutorials, including:


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!

For more information on each of the 3 tracks, click here to be directed to their pages:

Analytical Procedures and Methods Validation 

Stability Testing & Program Management

Laboratory Data Integrity Compliance Congress

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.

Pricing & Registration

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