Data Integrity in the Pharmaceutical Industry

MessageThis Webinar is over
Date Nov 7, 2018
Time (9:00 am to 10:00 am )
Cost $200.00
Online
Data integrity is essential to regulatory compliance within the pharmaceutical industry. MHRA, FDA and WHO have all issued guidances on data governance, and assurance of data integrity forms a key part of regulatory inspections. Recent Warning Letters to pharmaceutical companies have highlighted data integrity failures.

Areas Covered in the Session :
  • Understanding data integrity?
  • How does data integrity apply to GxP?
  • Recent data integrity findings in regulatory inspections
  • Human factors in data integrity failures
  • What does industry have to do?
  • MHRA, FDA and WHO guidances

Who Should Attend:Staff involved with GMP and GDP regulated activities in pharmaceutical development, manufacturing and distribution companies:
  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Warehousing
  • Supply Chain/Outsourcing
  • Regulatory Affairs
  • Research and Development
  • API Manufacturers
  • GMP/GDP Compliance
  • Contract Manufacturing Organizations
  • Contract Testing Laboratories

 


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