ARTICLES BY TOBIAS KUNERS OF KOENDERS
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The 5-Step Checklist For A More Mature, Robust Quality Management System8/20/2021
Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.
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Quality Management Review — Benchmarking Quantitatively!1/29/2021
Typically, when the cost of quality is depicted, it is split into “cost of control” and “cost of failure of control.” At the next level of detail, the costs of prevention and appraisal appear on one side and the costs of internal failure and external failure on the other side. How to interpret and implement these buckets at the tactical level is often left to personal imagination.
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Is It Time To Stop Using Mean Kinetic Temperature (MKT) In Pharma Storage & Transport?12/28/2020
MKT continues to be proposed in USP chapters <659> and <1079> and is presented as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variation. However, there is too little or no emphasis on the physics or chemistry behind the impact of temperature excursions on biological drug products and other contemporary drugs.