Stability Data Records and Reports – A Balancing Act of Quality, Efficiency and Speed (Stability)

Venue: Live Instructor Led Online

Location: Live Instructor Led Online, United States

Event Date/Time: Feb 05, 2009 End Date/Time: Feb 09, 2009
Registration Date: Feb 04, 2009
Early Registration Date: Jan 10, 2009
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In a world that increasingly relies on electronics, the laboratory notebook remains the principal means of recording data in the Pharmaceutical industry, particularly in the R&D environment. However, it is imperative that the documentation system used to record analytical data (whether electronic or paper) be designed to not only satisfy all regulatory requirements surrounding stability testing, but also allow for easy retrieval and data trending.

This live and comprehensive 3-session course will present the evolution of raw data recording to ensure quality and increased efficiency from bound laboratory notebooks, to laboratory worksheets and the electronic notebook. A case study will also be presented to introduce the use of a laboratory worksheet system in an analytical R&D department to record stability data for routine testing.

Discussion Points:

Session 1: Understanding Regulatory Expectations for Raw Data Records and Reports

cGMP requirements for data reporting
Impact of record deficiency
Warning Letter Citations
Recording stability data for submissions

Session 2: Managing Stability Data to Ensure Quality

Mode of raw data recording
Establishing structure for reporting data
Automating data review and approval
Developing a training system to remediate deficiencies

Session 3: Structuring Stability Reports to Improve Efficiency

Anatomy of a Stability Report
Designing and formatting summary reports
Determine deficiencies and assessing risks of documentation
Integrating Laboratory records to accelerate Data Reporting Process