Training for Investigators

Severity and impact of a Deviation/Discrepancy are frequently triggering an intensive Investigations which have to be performed by qualified, independent personnel, the Investigators. The different phases of the evaluation process and the tools to be used must be defined in writing, e.g. for Classification, Root Cause Analysis, planning of immediate measures and decision making.

The training aims to build the capabilities of investigators in order to conduct timely and effective investigations and to make them familiar with the regulatory expectations, their responsibilities and the process in detail.

Target Group:
Employees from the GMP regulated areas (manufacturing, QC, QA, tech. services) who will assume the Investigator’s role in future.
Participants need GMP knowledge in order to follow the training course.


08.30 - 08.45 Introduction, aim of the training
08.45 - 09.30 Regulatory requirements, Qualification & Responsibilities of an effective Investigator and the team
09.30 - 10.00 The Investigation Team, planning, worksheet
10.00 - 10.15 Morning coffee
10.15 - 11.00 Problem statement and Impact Assessment
11.00 - 11.45 Initial Mitigation Actions, Classification of deviations
11.45 - 12.30 Root Cause Analysis (RCA) tools
12.30 - 13.30 Lunch
13.30 - 14.00 Criteria for notification to Health Authorities (EU/FDA)
14.00 - 14.30 Multi-site investigations (if applicable)
14.30 - 14.45 Coffee
14.45 - 15.30 The CAPA process
15.30 - 16.00 Investigation reporting, approval & closure
16.00 - 16.45 Investigator’s insights to Technical Processes (designed according to company business)
16.45 - 17.00 Q & A


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