GMP overview
This webinar has been designed to provide participants with a solid knowledge of the current GMP requirements and regulations in concentrated form.
The specific characteristics of GMP as well as the links between different requirements will be presented. Important definitions and abbreviations will be covered. Specific requirements, which apply to suppliers and service providers, will be addressed as well.
Programme
IntroductionPrinciples of GMP
Scope of GMP
Historical background
GMP core requirements
Basic principlesBinding character of GMP rules
GMP vs. ISO
Overview of GMP requirementsQuality Management
Functions and responsibilities
PersonnelResponsible persons in an organisation
Training
DocumentationWorking regulations, SOPs
Protocols, reports
HygienePersonnel hygiene
Production hygiene
Monitoring
Deviations and VariationsDeviations vs. Variations
CAPA
Classification