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LABORATORY UNIVERSITY

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Develop, Implement and Maintain Processes that Survive the Product Life Cycle

June 22 - June 24

San Diego, United States

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.

 

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


  • 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/

Partners

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Venue

Details

Start:
June 22
End:
June 24
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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