ECA Certified
Data Integrity Manager

ECA Certified Data Integrity Manager

Although Data Integrity has been one of the basic GMP requirements for decades it became the regulators’ focus of attention over the last few years. In the course of inspections of the U.S American FDA and European competent authorities, a lot of deviations and failures on that topic were detected. Current FDA Warning Letters and European Non-Compliance reports reflect the situation and show the weak points of data management in pharmaceutical companies. Meanwhile, major international authorities like FDA, MHRA, WHO and PIC/S have developed new Guidelines and Guidances on Data Integrity and Data Governance to explain their expectations to the industry.

In the GMP Certification Programme "Data Integrity Manager", participants obtain a comprehensive knowledge of the basic principles of Data Integrity and Data Governance. Participants will understand the data lifecycle and how the regulatory expectations can be implemented into the companies’ Quality System.

Courses and Conferences acknowledged

To receive the certificate, the applicant must attend three out of the following courses / conferences. After attending the third course, the applicant obtains the certificate "ECA Certified Data Integrity Manager". Please find some training courses below:

  • HPLC Data Integrity
  • Data Integrity and Good Documentation
  • Data Integrity
  • Laboratory Data Integrity: Meeting FDA & EU Concerns
  • Data Integrity Master Class
  • Audit Trail Review
  • Audit Trail Review for Comp. Systems in Analytical Laboratories
  • Raw Data: Understanding, Defining and Managing
  • Data Integrity Quality Oversight in the GMP Regulated QC Laboratory AND Audit Trail Review Workshop
  • Lab Data Integrity Master Class
  • D.I.C.T. - Data Integrity in Clinical Trials

Your Questions

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