GMP: The Basics

New Training in English Language
GMP overview on current requirements
GMP refresher and initial GMP knowledge
How do you work correctly in a GMP environment?
Overview about legal background and a number of GMP processes

Objectives

• GMP principles
• Provision of basic knowledge on GMP
• Overview of requirements
• Specifics of GMP
• Explanation of wordings and definitions, Elucidation of abbreviations
• GMP rules Germany, EU, Switzerland and USA
• Documentation, Deviation, Variations

Speciality

• Navigation in the GMP environment
• Voluntary Assessment at the end of the seminar
• Certification of the GMP knowledge
• Booklet free of charge GMP-I’m part of it

Who should attendPersonnel working in

• production
• packaging
• quality units
• technical areas
• purchasing

Personnel in GMP related areas who want to get a compact overview of the GMP requirements.
Employees who want to refresh their knowledge but also those who just started in their position.

Industries

• Pharmaceutical Manufacturers
• API and Excipient Manufacturers
• Wholesalers
• Suppliers e.g. raw materials, equipment
• Service providers

GMP overviewThis training has been designed to build a solid knowledge about the current GMP requirements and regulations to the participants in a concentrated form.
The specific characteristics about GMP as well as the links between different requirements will be presented. Important definitions and abbreviations will be presented.
Specific requirements, which apply to suppliers and service providers will be addressed as well.
This course will improve the GMP awareness of the participants and connected to that the GMP compliance in the day to day work environment.
It also supports and will enrich the internal training programme which is the basis for each employee to work in a GMP environment.

GMP Refresher and Initial knowledge for local and international companiesThe course is intended for employees who want to refresh their GMP knowledge and also for newcomers working in a GMP environment.
It will be valuable for employees of local and international companies who should be prepared to communicate in English language

Certification of the GMP knowledgeThis course will finish with an assessment of success. It therefore serves also to comply with the GMP requirements to proof the required GMP knowledge. It can be a prerequisite to offer services in the GMP environment.
Participation in the assessment is optional.

Programme

IntroductionPrinciples of GMP
Scope of GMP
Historical background
GMP core requirements

GMP rules Switzerland, Germany, USAEuropean rules
Supporting rules

Basic principlesBinding character of GMP rules
Regulatory approval of drugs
Regulatory supervision
GMP vs. ISO, ISO 9001, ISO 13485
Importance of the FDA
Specifics of an FDA inspection
GMP certificates

Overview on GMP requirementsQuality Assurance
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

Quality ControlAnalytical tests
Specifications
OOS
Trend analysis
Product Quality Review PQR

HygienePersonnel hygiene
Production hygiene
Facilities, Hygiene areas, equipment
Monitoring

Qualification and validationPhases of qualification
Calibration
Maintenance
Varieties of validation
Validation Master Plan

Deviations and Variations
Deviations vs. Variations
CAPA
Classification
Change Management process

Positive Rückmeldungen vom letzten Seminar

• Discussions
• Many examples and informations
• Good Organisation and presentations