Data Integrity: FDA/EU Requirements and Implementation

  • 26-27 Mar 2020
  • San Diego, CA, United States

Description

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 San Diego, CA, United States on 26-27 Mar 2020.

Venue

San Diego,
California,
United States
  View all Hotels near Venue

More Details

1699-2099 US Dollar
No exhibition
ComplianceOnline

Future Events

  • Data Integrity: FDA/EU Requirements and Implementation - 26-27 Mar 2020, San Diego, CA, United States (87149)
  • Data Integrity: FDA/EU Requirements and Implementation - 2020 (87150)

Past Events

  • Data Integrity: FDA/EU Requirements and Implementation - 12-13 Dec 2019, K+K Hotel George Kensington, London, United Kingdom (59480)
  • Data Integrity: FDA/EU Requirements and Implementation 2018 - 2018, Hilton Zurich Airport, Zurich, Switzerland (70362)
  • Data Integrity: FDA/EU Requirements and Implementation 2017 - 27-28 Sep 2017, Hilton Zurich Airport, Zurich, Switzerland (60989)

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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