Webinar: Analytical Instrument Qualification: GAMP-Regulations for Computer System Validation & Data Integrity
Im Auftrag der ECA Academy

Webinar: Analytical Instrument Qualification: GAMP-Regulations for Computer System Validation & Data Integrity Im Auftrag der ECA Academy

Seminar Nr. 18857

All times mentioned are CEST.

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Sprecher

Dr. Karl-Heinz Bauer, Boehringer Ingelheim International GmbH, Ingelheim

Hintergrund

In QC laboratories, there is a large number of analytical devices that need to be qualified according to GMP regulations and shall be kept in a qualified status over the entire life-cycle of the device. Smoothly running device functions strongly depend on error-free software features. The decision for a validation concept or a process model has far-reaching consequences, especially for the meaningfulness of the suitability of the software and device and the validity of its desired purpose as well as for the testing and documentation efforts. Special attention is paid to Data Integrity of the generated data.

Zielgruppe

This webinar is designed for employees from analytics, quality control, engineering and quality assurance who are responsible for device qualification or with device operation responsibilities. In addition to employees of pharmaceutical companies and external laboratories, employees of service providers in the areas of qualification / validation are also addressed.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

This webinar provides you with basic information about software validation concepts and shows you how to proceed using selected practical examples. The principles for Data Integrity, for different software functions/types and for supplier involvement within the framework of the computer system validation are specifically addressed.

Computerized Systems & Devices (Introduction into CSV)
  • GAMP Guidelines for Computerized System in QC Laboratories in a nutshell
  • Reference to USP <1058> Analytical Instrument Qualification
  • Terms and Definitions
  • Software categories according to GAMP 5 Guidelines
  • Core elements of a holistic CSV approach
  • Life cycle concept / The V-model
  • Software features and types
  • Functional specifications and requirements
  • Measures to maintain a valid Computerized System throughout its entire Life-Cycle
  • Data Integrity (ALCOA), Data Security, System Modification,
  • Incident and Emergency Management
  • Supplier participation and collaboration

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