Seminar Nr. 16239
|Non-ECA Members:||EUR 1690,--|
|ECA Members:||EUR 1490,--|
|EU GMP Inspectorates:||EUR 845,--|
|APIC Members (does not include ECA membership):||EUR 1590,--|
Alle Preise zzgl. MwSt.
Tel.: 06221 / 84 44 0 E-Mail: firstname.lastname@example.org
During this course, you will learn all relevant aspects to efficiently organise and improve your Complaint Handling and Recall System to fulfil current GMP requirements and to get the best benefit for your daily business.
In principle, every complaint might cause a recall, and every complaint may provide an opportunity to improve.
According to the EU-GMP Guide Chapter 8, the pharmaceutical industry must review all complaints and other information concerning potentially defective products carefully according to written procedures. In order to provide for all contingencies, a system should be designed to investigate the need to recall, if necessary, promptly and effectively products known or suspected to be adulterated from the market-place.
According to the EU- GMP Guide, a person should be designated responsible for handling the complaints and deciding the measures to be taken. The Qualified Person (QP) should be made aware of any complaint, and be actively involved in the investigation and any subsequent recall.
The handling of technical complaints (also called non-medical complaints) triggers high demands on the process organisation and quality system. However, these complaints are also a chance for continuous improvement and to prevent the reoccurrence of future failures.
This course is designed for all personnel involved in complaint handling and/ or recall activities at their company and all responsible persons like the Qualified Person / the Qualified Person for Pharmacovigilance (QPPV) and decision makers who want to improve the existing process.
Regulatory Requirements for Complaint Handling and Recalls - The Inspector’s View