STABILITY TESTING &
PROGRAM MANAGEMENT

AGENDA

1:30 PM
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
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.



7:30 - 8:15 AM
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
Program Development, Implementation and Maintenance

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



10:30 - 12:00 PM
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
Post Approval Change and Stability Testing

Junghae Scott, Principal, J Scott Consulting



1:15 - 2:45 PM
Application of Bracketing & Matrixing Designs in Stability Testing

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



3:15 - 4:45 PM
Validation of Stability-Indicating Analytical Methods

Commissioning Agents, Inc. (CAI)



3:15 - 4:45 PM
Statistics in Stability Studies – Evaluating Data

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



7:30 - 8:15 AM
Building Effective and Efficient Stability Protocols

John O’Neill, Editor, StabilityHub



10:30 - 12:00 PM
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
Shelf-Life Modeling using ASAP (Accelerated Stability Assessment Program)

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



1:15 - 2:45 PM
Using Statistics for Process Capability, Stability and Control

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



3:15 - 4:45 PM
Introduction to Medical Device Stability Testing

Chris Latoz, Stability Manager, Hollister Incorporated



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

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.  KENX is pleased to announce that our comprehensive Stability Testing & Program Management is headed to San Diego to showcase programs and procedures that excel and avoid regulatory action.


Stability Leaders Showcase Best-In-Class Programs

  • Develop and Validate Stability-Indicating Analytical Methods
  • Learn How to Perform Risk-Based Stability Testing
  • Build and Manage a Stability Program from the Ground Up
  • Establish Change Control Procedures for Stability Programs
  • OOS/OOT – Learn How to Handle Testing Variation
  • eStability – Automate Drug Stability Reporting Validation Procedures
  • Use Container Closer System Integrity Testing as a Stability Protocol
  • Apply Bracketing and Matrixing Designs for Testing
  • Evaluate overall Photosensitivity through Forced Degradation Testing Studies
  • Discover the Most Effective Approach for Evaluating Stability Data
  • Stability Data Integrity – Implement a Governance Program
  • Manage Storage Conditions in Zones III and IV
  • Predict Shelf Life through Accelerated Testing
  • FDA Inspections – Prepare for an FDA Audit
  • Case Study – Implement a Stability Program for Medical Device Manufacturing

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.

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.