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LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS

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

October 5 - October 7

San Diego, United States

Recent FDA Warning Letters Highlight Laboratory Data Integrity Deficiencies

 

Most data integrity non-compliance are cited in the GMP laboratory. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. KENX is pleased to announce that our comprehensive Laboratory Data Integrity Compliance Congress is headed to San Diego and showcases the protocols, methodology and actions necessary to avoid regulatory action.

 

Choose from Over 20 Tutorials Addressing Today’s Top Analytical Challenges

 

Laboratory Data Integrity Compliance Congress Highlights Include:

  • Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
  • Conduct a GAP Analysis and Identify Root Causes
  • Conduct an Laboratory DI Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Discover the Impact of Human Behavior
  • Implement Risk Management Protocols, Perform Assessments and Continually Verify
  • Prepare for and Handle FDA DI Investigations
  • Understand Requirements and Handle Audit Trail Reviews

 

Maximize Your Training! This Event is Co-located with Analytical Procedures and Methods Validation:

  • Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • Define and Develop the Content and Scope of Analytical Procedures Program
  • Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • Develop a Roadmap for Analytical Methods Validation
  • Evaluate Characteristics through Statistical Analysis of Validation Data
  • Development and Validation of a Stability-Indicating Analytical Method
  • Learn How to Perform Risk-Based Evaluations
  • Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • Handle the FDA Laboratory Methods Verification Process
  • Effectively Manage Transfer Studies and Protocols

 

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


  • 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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