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.
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|