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Join SGS to learn about the criteria for data integrity and how to apply it to your laboratory. Data integrity is a hot topic for regulators and auditors, so avoid the risk of incomplete data, lack of audit trails and falsification of results occurring during inspections.

Starts

October 25, 2018

Ends

October 25, 2018

Location

Online

Agenda

  • Data integrity (what/why)
  • Data life cycle management
  • Core data integrity concepts
  • Actions to compliance
  • Case studies
  • Conclusion
  • Q&A

Background

Data integrity is one of the basic GMP principles since multiple data integrity citations were reported by the US Food and Drug Administration (FDA) and European inspectors in the last three years. Many US Warning Letters and EU Non-Compliance Reports deal with serious data integrity violations. Data integrity questions have been and will continue be the focus of many GMP inspections.

As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA – have published draft documents to describe the regulatory expectations of data integrity. 
Although these guidelines are not intended to impose an additional regulatory burden on regulated companies, there is a lot of uncertainty in the pharmaceutical industry on how to implement these requirements into everyday activities.

Presenter

Ioannis Manolopoulos – Life Science Manager, Validation Team Leader

Target Audience

The webinar is aimed at

  • CSV engineers
  • Laboratory data integrity officers
  • Managers and scientists from analytical development laboratories and quality control
  • Quality assurance personnel
  • Contract research (CRO) and contract manufacturing organization (CMO) laboratory staff and QA personnel
  • Compliance managers and regulatory affairs managers
  • GMP and CMC consultants, GLP auditors and quality consultants
  • Laboratory managers, laboratory supervisors and production managers
  • Auditors (internal and external) responsible for assessing laboratory quality and data integrity
  • Anyone concerned with understanding the importance of data integrity in the audit process
 

Date and time

Thursday, October 25, 2018 2:00 pm
Europe Summer Time (Amsterdam, GMT+02:00) 
        
Thursday, October 25, 2018 3:00 pm
Greece Summer Time (Athens, GMT+03:00)  

Thursday, October 25, 2018 1:00 pm
GMT Summer Time (London, GMT+01:00)