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DATA INTEGRITY INSPECTION READINESS SUMMIT

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Risk-Based Approaches that Impress FDA Investigators

March 25, 2019 - March 27, 2019

PHILADELPHIA, United States

FDA Warning Letters Highlight Data Integrity Deficiencies

 

Data Integrity remains the life science industry’s greatest challenge as Warning Letters continue to rise year-over-year. 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 Data Integrity Inspection Readiness Summit is headed to Philadelphia to showcase the protocols, methodology and actions necessary to avoid regulatory action.

 

Be Prepared for the FDA Inspection Headed to Your Facility Soon!

  • Understand the Human Factor for Compliance
  • Learn How to Build a Program from the Ground Up
  • Identify the Root Cause of Inaccuracies
  • Conduct an Audit/Gap Assessment and Implement Corrective Action
  • Comply Across the GxP Environment
  • Benchmark With Manufacturing, Laboratory and Clinical Top Companies
  • Address Malicious Threats through Cybersecurity Best Practices
  • Conduct Data Integrity Risk Assessments
  • Know How to Handle Audit Trails

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Data Integrity and Document Management
  • Regulatory Affairs
  • Manufacturing, Laboratory and Clinical Management

 

This event is also appropriate to business development and sales managers that offer innovative solutions for data integrity, validation, quality and data collection environments.

 

This Conference is Co-Located with VALIDATION UNIVERSITY with In-Depth Coverage On:

  • Process Validation and Continued Process Verification
  • Cleaning Validation & Critical Cleaning Processes
  • Facility and Equipment Qualification
  • Critical Utility Qualification – HVAC, Water and Gas
  • Computer Systems Validation

Agenda

More Information To Follow Soon

Faculty

    More Information To Follow Soon

Sponsors

Partners

  • 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
  • Pharmaceutical Manufacturing

    Keen insights into the major manufacturing issues facing the industry today
    Website: http://www.pharmamanufacturing.com
  • FDA News

    Latest information for executives in industries regulated by the U.S. Food and Drug Administration
    Website: https://www.fdanews.com

Venue

Details

Start:
March 25, 2019
End:
March 27, 2019
Event Category:

Venue

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

Pricing & Registration

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