GMP overview
You need to communicate about GMP in English? GMP-compact is a training course presented in English. This training 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.
This course will improve participants' GMP awareness and in connection will raise GMP compliance in the day-to-day work environment. It also supports and will enrich the internal training programmes which are the basis for each employee to work in a GMP environment.
Programme
IntroductionPrinciples of GMP
Scope of GMP
Historical background
GMP core requirements
GMP rules Germany, Switzerland, USAEuropean rules
Supporting rules
Basic principlesBinding character of GMP rules
Regulatory approval of drugs
Regulatory supervision
GMP vs. ISO
Overview of GMP requirementsQuality Management
Functions and responsibilities
Supplier qualification
Self-inspections
PersonnelResponsible persons in an organisation
GMP personnel
Training
Individual responsibility
DocumentationWorking regulations, SOPs
Raw data
Protocols, reports
Logbooks
Product Quality Review, PQR
Quality ControlAnalytical tests
Specifications
OOS, OOT
HygienePersonnel hygiene
Production hygiene
Monitoring
Qualification and ValidationPhases of qualification
Validation of processes
Calibration
Maintenance
Deviations and VariationsDeviations vs. Variations
CAPA
Classification
Change Management process