GMP and FDA Compliance in Quality Assurance Units

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

  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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK