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Stability Testing & Program Management

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Implement Best-In-Class Procedures through the Product Life Cycle

June 25 - June 27

San Diego, United States

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
  • Walk through a Case Study for Stability Testing of New Drug Substances and Products
  • 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
  • Biologic Case Study – Establish Testing Limits for Standardized Grass Pollen Extracts
  • 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.

 

Send Your Team!  This Event is Co-located With:

Agenda

  • 12:00
    Conference Registration
    Coffee and Lite Snacks On-the-Go
  • 1:15
    Chairperson’s Opening Remarks
  • 1:30
    Build and Manage a Global Stability Testing Program
    Evald Muraj, Senior Manager QC/Stability, Ironwood Pharmaceuticals
  • 3:00
    Afternoon Refreshment Break
  • 3:30
    Top Challenges to Build Quality Systems in Analytical and Stability Laboratories
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • 4:15
    The MHRA Guidance on Data Integrity and the Major Differences with FDA’s Draft
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology, LLC.
  • 5:00
    KENX/Temple Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 07:30 – 08:15
    Knowledge Exchange Breakfast Discussion
  • Application of Bracketing and Matrixing Designs in Stability Testing
    Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals
  • 8:30-10:00
    FDA Inspections: Focus and Management of an FDA Audit in Stability
    Greg Norcross, QC Compliance Manager, Novartis Technical Operations
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30-12:00
    Knowledge Exchange Session
  • Monitoring Organic Impurities and Degradation Products in Stability Program
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • 12:00
    Focus Group Luncheon
  • Ensure Results Meet Criteria through Effective Test Method Selection and Specification Setting for Combination Products
    Jian Liu, Ph.D., Stability Manager, Abbott
  • 1:15-2:45
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Development and Validation of a Stability-Indicating Analytical Method
    Peju Odunusi, Group Leader, Stability, Abbott Vascular
  • (2)
    Shelf Life Determination for Medical Devices and Combination Products
    Jian Liu, Ph.D. Stability Manager, Abbott
  • 3:00
    Afternoon Refreshment Break
  • 3:30-5:00
    Knowledge Exchange Session
  • Stability Data Integrity – Building a Governance Program from the Ground Up
    Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals
  • 5:00
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 07:30 – 08:15
    Knowledge Exchange Breakfast Discussion
  • OOS/OOT - Learn How to Handle Testing Variation
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology, LLC.
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (3-4)
  • (3)
    Science and Risk-Based Approaches to Stability Studies in Product Development Process
    Peju Odunusi, Group Leader, Stability, Abbott Vascular
  • (4)
    Post Approval Changes for Stability
    Junghae Scott, Director QC, Relypsa, Vifor Pharma Group Company
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (5-6)
  • (5)
    Fit for Purpose Statistics for Stability: Shelf-Life Modeling & Trending
    Katherine Giacoletti, Partner, SynoloStats LLC
  • (6)
    Successful Selection, Implementation and Validation of a Stability LIMS (Laboratory Information Management System)
    Chris Latoz, Manager Stability and Analytical Services, Hollister Incorporated
  • 12:00
    Focus Group Luncheon
  • Advanced Stability Master Class
    To Be Announced
  • 1:15-2:45
    Knowledge Exchange Session
  • Using Container Closer System Integrity Testing as a Stability Protocol
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology, LLC
  • 2:30
    Afternoon Refreshment Break
  • 3:00-4:30
    Knowledge Exchange Session
  • Managing an Outsourced Quality Stability Program
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • 4:30
    Close of Conference

Faculty

  • Katherine Giacoletti - Partner, SynoloStats LLC

    Katherine has worked as a statistician in the Pharmaceutical industry for over 17 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics from North Carolina State University, with a focus in biostatistics. Katherine lives and works in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
  • Kim Huynh-Ba - Executive Director, Pharmalytik

    Kim is an accomplished author and speaker of the compliance and quality areas, both domestic and internationally. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010) published by Springer. She is currently working on a manuscript of “Analytical Chemistry: an introduction to pharmaceutical analysis,” expecting to be available late 2018. She can be contacted at kim.huynhba@pharmalytik.com.
  • Steven S. Kuwahara, Ph.D - Principal Consultant, GXP BioTechnology, LLC

    Steven S. Kuwahara, Ph.D., is principal consultant at GXP BioTechnology, LLC (www.gxpbiotech.org) in Sunnyvale, CA. Steve has more than 30 years experience supervising quality control department dealing with drugs, biologics, HCT/P, and nutraceuticals. He has supervised animal facilities and testing laboratories that operated under GLP rules and also those operating under GMP and ISO standards. He may be reached by e-mail and by phone at 408-530-9338.
  • Chris Latoz - Manager Stability and Analytical Services, Hollister Incorporated

    Christopher (Chris) V. Latoz is Manager, Stability and Analytical Services at Hollister Incorporated in Libertyville, IL. Chris has over 25 years’ experience in the medical device industry (Class I and II devices) working in R&D, Technical Services, and more recently, Stability. While at Hollister, Chris has led several process and capacity improvement projects, including: the implementation of a LIMS (Laboratory Information Management System) for stability sample and data management; the construction of new walk-in stability storage chambers; and the implementation of a temperature and humidity monitoring system for stability chambers.
  • Jian Liu, Ph.D. - Stability Manager, Abbott

    Dr. Liu currently is a manager of stability department in the Analytical Chemistry Research and Technology of Abbott Vascular. Dr. Liu has over 20 years of extensive experience of analytical chemistry and stability program in the pharmaceutical and medical device industry. His pharmaceutical industry experience at Watson Pharmaceuticals focused on analytical chemistry for solid dosage products. Dr. Liu’s medical device industry career at Abbott Vascular (formally Guidant) started in analytical method development, validation and transfer for Drug Eluting Stents (DES) products.
  • Carmen Medina, MPH, PhD© - VP Technical Services, PAREXEL International

    Ms. Medina uses over 30 years of FDA experience to support an array of international clients in their preparations for successful Pre-approval, GMP, GCP and combo-device inspections. She was a former Commissioned Officer in the United States Public Health Service and a PAI Investigator with the FDA, where she led an international group within Team Biologics and helped usher in the new medical device QSR regulations. Over the past 28 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands and bio-generics. See her textbook on Amazon: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics.
  • Bette Monnot-Chase - Director, CMC & Quality, Asklepion Pharmaceuticals

    Bette has a strong background in drug development in the areas of analytical method development, stability, formulation, validation, and vendor management. Her main responsibilities included stability, product development and associated analytical testing, as well as preparation of regulatory CMC documents for global filings. Working for small Pharma that adopted a virtual model - outsourcing all CMC activities to third party vendors, Bette has extensive experience managing the need of her projects and the vendor’s needs, which is necessary to delivery high quality analytical methods, robust formulation and critical stability data to support the product in a global clinical or commercial marketplace.
  • Evald Muraj - Senior Manager QC/Stability, Ironwood Pharmaceuticals

    Mr. Muraj has led stability programs in the bio-pharmaceutical sector for on-site manufacturing operations, virtual manufacturing models and global business networks that combine the two. His experience in global stability execution ranges from small molecule to biologics. His expertise focuses specifically on the use of statistical analysis and advanced degradative models to interpret shelf-life, and he has chaired multiple conferences on this subject for the past decade.
  • Greg Norcross - QC Compliance Manager, Novartis Technical Operations

    Mr. Norcross has a background with over 30 years experience in management of pharmaceutical stability testing and analytical laboratory management including being the subject matter expert for numerous FDA audits and other internal and external audits.
  • Peju Odunusi - Group Leader, Stability, Abbott Vascular

    Dr. Peju Odunusi is an analytical R&D professional with over 23 years of experience in the pharmaceutical and medical device industries. She has technical expertise in method development and validation, stability support for all phases of product development, method transfer, submissions, audits and has successfully established analytical and stability groups. She is also very passionate about mentoring.
  • Junghae Scott - Director QC, Relypsa, Vifor Pharma Group Company

    Ms. Junghae Scott is a Director of Quality Control at Relypsa in Redwood City, California (a Vifor Pharma Group company). Ms. Scott has 30 years of industry experience in CMC, analytical development, and quality control covering Pharma, Biotech, Medical Device, and Combination Products from start-ups to Fortune 500 companies. She received her Master Degree in Chemistry at University of San Francisco.
  • Emily S. D. Trubee, MS - Stability Manager, ADARE Pharmaceuticals

    Ms. Trubee is a pharmaceutical professional with 14 years of experience in Quality Control, and Stability Testing and Management, with a focus on regulations-compliant stability programs for sterile injectables, solid oral dosage forms, and biological products. In her current role as Stability Manager, Research and Development at Adare Pharmaceuticals, she is responsible for managing the stability lifecycle of all products from pre-clinical through commercialization. Emily earned her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, OH and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

Sponsors

  • GOLD


  • ValGenesis

    Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • SILVER


  • AVQC

    AVQC, Array Validation Quality & Compliance, Inc. is a Multinational Life Sciences Global Compliance Consulting Firm with 25 + years experience delivering Technical Writing and Validation Services in the Pharmaceutical, Medical Device, Biotechnology and Food Industries.
    Website: https://avqc.com/
  • Bahnson

    Bahnson Environmental Specialties (BES) designs and manufactures a diverse product line of controlled environmental chambers that maintain precise conditions for clients' research, development, and manufacturing processes. BES has expanded from a respected regional company to a national leader in chamber design, on-site construction, and performance qualifications. Our 45 -year reputation is built on component quality, tolerance integrity, and an approach to engineering that exceeds even the most rigid requirements. Welcome to a Bahnson level of chamber precision.
    Website: http://www.eschambers.com
  • Kneat

    Digitally Transforming GxP Validation Processes
    Website: http://kneat.com/
  • Novatek

    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.
    Website: http://ntint.com/
  • VTI Life Sciences

    Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/
  • Wilco

    Leak Detection and Inspection Machines. Experience and innovation since 1971
    Website: http://www.wilco.com/
  • ACADEMIC


  • Temple University School Of Pharmacy

    RAQA: Combined, Defined, and Online. The Leader in Education RA and QA Professionals for 50 Years
    Website: http://www.temple.edu/pharmacy_qara

Partners

Venue

Details

Start:
June 25
End:
June 27
Event Category:
Website:
https://www.kenx.org/events/stability-testing/

Venue

The Bahia Resort Hotel
998 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(858) 488-0551
Website:
http://bahiahotel.com/

Pricing & Registration

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