Ensuring Integrity and Security of Laboratory Data

Ensuring Integrity and Security of Laboratory Data is an online event dedicated to fDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for implementation.

Ensuring Integrity and Security of Laboratory Data covers topics such as:

  • How FDA inspectors check integrity and security of data
  • Eight key FDA/EU requirements for integrity and security of laboratory data
  • The importance of limited access to `individual users` rather than to groups
  • Most frequent security and integrity issues: going through recent 483`s, EIRs and warning letters?
  • Critical integrity and security issues during the entire life of laboratory data: from data acquisition through evaluation to archiving
  • FDA compliant definition, acquisition, maintenance and archiving of raw data
  • Documenting changes of laboratory data: paper, hybrid systems, electronic
  • Examples how to ensure and document data integrity
  • Review of electronic audit trail: who, what, when and how
  • The importance of electronic audit trail to document data integrity
  • Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
  • Ensuring timely availability through validated back-up and archiving

Ensuring Integrity and Security of Laboratory Data intended for:

  • Pharmaceutical and Device Manufacturers
  • All companies generating laboratory records in regulated environments
  • Contract Laboratory Organizations providing services for GxP compliance
  • API Manufacturers
  • QA/QC managers and personnel
  • Documentation professionals
  • Validation specialists
  • Analysts and lab managers
  • Training departments
  • Regulatory affairs
  • Consultants

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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