GMP and FDA Compliance in Quality Assurance Units

  Content Day 1
08.00 - 08.30 Welcome, Presentation of the Speakers
08.30 - 09.30 Regulatory Requirements Applying to QA Units
09.30 - 10.30 Out of Specification (OOS)
10.30 -10.45 Break
10.45 - 11.45 Failure Investigation
11.45 - 12.45 Validation of Analytical Procedures
12.45 - 13.30 Lunch
13.30 - 15.30 Workshop I
  • Supervision of Contract Manufacturers
  • Risk Analysis
15.30 - 15.45 Break
15.45 - 16.30 Presentation/Discussion of Workshop Results
16.30 - 17.30 Self Inspection and Auditing
  Content Day 2
08.30 - 09.30 Change Control System
09.30 - 10.30 Deviation Management
10.30 - 10.45 Break
10.45 - 12.15 Workshops II
  • Annual Product Review
  • Trending of QA Parameters
12.15 - 13.00 Lunch
13.00 - 14.00 Presentation/Discussion of Workshop Results
14.00 - 15.00 Process Validation and Equipment Qualification
15.00 - 15.15 Break
15.15 - 16.15 QA Involvement in R & D/Documentation Control/Archiving
16.15 - 17.00 Final Remarks/Discussion

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