Introduction GMP Validation 

Purpose

For GMP, the importance of guaranteeing constant product quality applies. Every end product that is marketed or distributed must meet the requirements for safety and effectiveness. Employees directly or indirectly involved in the production of medicines and/or High Grade Food must be aware of the risks involved in production and the importance of the GMP rules.

Target Audience

Employees of High Tech, Food and Pharmaceutical companies whose activities are directly or indirectly related to GMP, such as operators and QA/QC officers. But also employees of purchasing, sales, production planning, human resources, technical service, IT, document management and administration.

Intent

This training consists of 1 half day (4 hours) and deals with the basic principles of GMP with an emphasis on the translation from theory to practice. A combination of theory and practice, the participants receive an explanation of what, how and why GMP. GMP requires enormous discipline from employees, which is why good motivation is essential.

 Program

·        Validation in pharmaceutical industry

·        Explanation V-model

·        Validation steps and documents

·        Risk Assessment

·        Commissioning

·        Qualification steps

·        Deviation

·        Rapports

·        Calibration

·        Change Control 

Qty participants  8 - 12