Data Integrity: FDA/EU Requirements and Implementation

  • 25-26 September 2019
  • Singapore, Singapore

Data Integrity: FDA/EU Requirements and Implementation covers topics such as:

  • Why there are so many data integrity issues
  • What data integrity is and why it is so important for public health
  • How to define and archive raw data from hybrid systems: electronic vs. paper
  • The FDA/EU/PICS/MHRA/WHO requirements for data integrity
  • How to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
  • Specify and validate Part 11 compliant software functionality
  • How to develop and implement corrective and preventive action plans in response to inspection reports
  • FDA`s New and ongoing Part 11 inspection and enforcement practices
  • How to prevent and detect data integrity issues
  • How to avoid and/or respond to FDA inspectional observations and warning letters

Data Integrity: FDA/EU Requirements and Implementation brings together:

  • Laboratory managers and supervisors
  • QA managers and personnel
  • Analysts
  • Production managers and supervisors
  • Software developers
  • IT/IS managers and system administrators
  • Training departments
  • Regulatory affairs
  • Consultants
  • Documentation departments
  • Quality control laboratories of API manufacturers
  • Pharmaceutical development and Quality control laboratories
  • Contract laboratories
  • Medical device companies
  • Suppliers and service providers of instruments and computer systems
  • Clinical Research Organisation

Data Integrity: FDA/EU Requirements and Implementation will be held in Singapore on 25-26 September 2019.

Venue

Singapore
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Booking.com
1699-1999 US Dollar
No exhibition
ComplianceOnline
Rentalcars Savings

Past and Future Events

  • Data Integrity: FDA/EU Requirements and Implementation - 2020 (87150)
  • Data Integrity: FDA/EU Requirements and Implementation - 25-26 Sep 2019, Singapore (87149)
  • Data Integrity: FDA/EU Requirements and Implementation 2018 - 2018, Zurich, Switzerland (70362)
  • Data Integrity: FDA/EU Requirements and Implementation 2017 - 27-28 Sep 2017, Zurich, Switzerland (60989)
  • Data Integrity: FDA/EU Requirements and Implementation 2016 - 5-6 Jul 2016, Zurich, Switzerland (59480)

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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