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STABILITY TESTING & PROGRAM MANAGEMENT

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October 5 - October 7

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
  • 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.

 

For an additional $995, you can earn 1.5 graduate credit hours towards Temple’s RAQA Graduate Program! For more information on the Temple Track for Lab University, email info@kenx.org, or call 856-281-7134.

Agenda

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Faculty

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Sponsors


  • 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/
  • 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
  • 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/

  • 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/
  • 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/
  • 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/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/
  • 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

Partners

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Venue

Details

Start:
October 5
End:
October 7
Event Category:
Website:
https://www.kenx.org/events/lab-data-integrity-2019/

Venue

Bahia Resort Hotel
998 W Mission Bay Dr
San Diego, 92109 United States
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Phone:
(858) 488-0551
Website:
https://www.bahiahotel.com/

Pricing & Registration

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