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Please note that we need about 3 months preparation for the organisation of your in-house training course.
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.
|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|