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Customised Internal Training Course Development On the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls Rule.

by Dr Faour Klingbeil / Friday, 30 October 2020 / Published in

Dr Faour-Klingbeil has been engaged with August Storck KG, the Berlin-based international confectionery manufacturer, to develop a customised internal training programme on Preventive Controls for Human Food under 21 CFR Part 117.

The programme was designed as a condensed, facility-relevant introduction to the FSMA Preventive Controls rule, tailored specifically to the responsibilities of a Preventive Controls Qualified Individual (PCQI). The challenge was to distil the most critical regulatory requirements into a focused, efficient 4-hours session without compromising the essential content staff needed to understand and fulfil their compliance responsibilities.

DFK delivered two integrated outputs for this engagement:

  • Training slides covering the core elements of the Food Safety Plan, the role and responsibilities of the PCQI, Current Good Manufacturing Practices, hazard analysis principles, and the prerequisite programmes underpinning an effective food safety system. All slides were supported with direct references to regulatory sources to enable further elaboration where needed.
  • A trainer guidance manual designed to equip the internal trainer with the context, explanations, and regulatory grounding needed to deliver the course confidently and accurately.

This engagement marked the beginning of a continuing collaboration with August Storck KG. In 2025, DFK was further engaged to conduct a pre-FDA inspection compliance audit at the company’s Berlin chocolate manufacturing facility, reflecting Storck’s continued commitment to strengthening their food safety systems and maintaining alignment with U.S. FDA export requirements.


Tagged under: Food Safety, FSMA, PCQI

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