Out-of-Specification Results

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
09.00 - 09.30 Registration
09.30 - 09.45 Introduction to course
09.45 - 10.30 Abberant & atypical results; OOS, OOE & OOT
10.30 - 11.15 Background to FDA OOS guidance
11.15 - 11.30 Coffe Break
11.30 - 12.30 FDA final guidance
12.30 - 13.00 Q & A session on major differences from the draft guidance
13.00 - 14.00 Lunch
14.00 - 15.00 Statistical aspects of OOS results
15.00 - 17.00 Workshop 1 on Laboratory OOS scenarios (includes afternoon break)
17.00 – 17.30 Q & A session
  Content Day 2
09.00 - 09.45 In specification results and risk based CGMPs
09.45 – 10.30 Best practices to reduce OOS results in the laboratory
10.30 - 10.45 Coffee Break
10.45 - 11.45 Analytical data quality management
11.45 - 13.00 Workshop 2 on trend analysis
13.00 - 14.00 Lunch
14.00 - 15.00 Conducting Failure investigations
15.00 - 17.00 Workshop 3 Failure investigation (includes afternoon break)
17.00 – 17.30 Q & A session and course wash up

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