The HACCP methodology as risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintain HACCP files documentation and find and define the checkpoints (CP) and critical checkpoints (CCP) in material flow from goods in control over the manufacturing steps until the final goods storage, which is mandatory for pharma and food manufacturing in several countries which use GMP methodology for pharma or similar systems for food manufacturing e.g. European Union or the US. HACCP files need to be structured according to the scientific state of the art according to the Codex Alimentarius, the requirements for the pharma or food quality and safety management system with the interfaces between risk file and processes to the quality and safety management system and the technical documentation and finally preparation process for file reviews by authorities in inspections is a required know-how. The inspectors have special expectations to cover the legal requirements.

You should attend because this course introduces you into the creation and maintenance of a HACCP file documentation and how to find and define your checkpoints (CP) and critical checkpoints (CCP) in material flow from goods in control over the manufacturing steps until the final goods storage. You will learn more about this risk management methodology, which is mandatory for pharma and food manufacturing in several countries which use GMP for pharma or similar systems for food manufacturing e.g. European Union or the US. You will learn more about the structure, term definitions, the requirements for the HACCP management file, the requirements for your pharma or food quality and safety management system with the interfaces between risk file and processes to your quality and safety management system and the technical documentation and finally how to prepare your HACCP file reviews by authorities and what are the expectations of the authorities to cover the legal requirements.