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Laboratory Data Integrity Compliance Congress

: 22 Jun 2020 - 24 Jun 2020

: San Diego, United States

Sector: Pharmaceutical

Type: Conference, Meeting, Training


Recent FDA warning letters highlight laboratory data integrity deficiencies.  Most data integrity non-compliances 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 a 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:

 

Personnel in the following environments should attend:

  • Validation
  • QA/QC
  • Scientist
  • Chemist
  • Laboratory Management
  • Regulatory Affairs
  • Data Integrity
Venue

San Diego
United States


Organizer

KENX Knowledge Exchange Network
Phone: 858 649 3251
Email: info@kenx.org
Visit: https://www.kenx.org/


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