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LABORATORY DATA INTEGRITY COMPLIANCE CONGRESS

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

June 17 - June 19

PHILADELPHIA, United States

Recent FDA Warning Letters Highlight Laboratory Data Integrity Deficiencies

 

FDA has issued many Warning Letters emphasizing data integrity non-compliance primarily in the  analytical environment. 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 Philadelphia and showcases the protocols, methodology and actions necessary to avoid regulatory action.

 

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

 

  • Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide
  • Learn the Methodology and Techniques Used to Identify Inaccuracies
  • Conduct an Laboratory Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Identify and Investigate Root Causes of Integrity Lapses
  • Cybersecurity Risk Management Implementation and Continued Verification
  • Perform a Risk Assessment for  Data Deficiencies
  • Understand Requirements and How to Handle Laboratory Audit Trails

 

This Conference is Co-Located with Analytical Method Development, Validation and Transfer Summit

  • 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.

Agenda

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Faculty

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Venue

Details

Start:
June 17
End:
June 19
Event Category:
Website:
https://www.kenx.org/events/lab-data-integrity-2019/

Venue

Wyndham Philadelphia Historic District
400 Arch Street
PHILADELPHIA, PA 19106 United States
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Phone:
(215) 923-8660
Website:
https://book.passkey.com/event/49826319/owner/16417/home

Pricing & Registration

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