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Date: 1st September, 2009

Location: On-Line, Canada

Summary:
Clinical, Pharmaceutical - Web Seminar

3-Session Live Web Training Course:
Session 1: September 1, 2009
Session 2: September 3, 2009
Session 3: September 10, 2009

Instructor: Kim Huynh-Ba
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