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Fritz Röder
Merck
Senior QA Manager
Fritz Röder is a recognized expert in the pharmaceutical industry who is currently employed as Senior QA Manager at Merck Healthcare KGaA, in Darmstadt, Germany. He has experience in pharmaceutical media supply, GMP environments, and the processing of solid, semisolid, and liquid (sterile) dosage forms, and has managed various large projects involving solid, semisolid, and liquid sterile dosage forms. He has also contributed to several audit projects for regulators in the US, Brazil, Germany, Russia, and other nations. Fritz is a member of the European Directorate for the Quality of Medicines & HealthCare Working Group on Water, the ISPE D/A/CH Affiliate Expert Group on Water and Steam, the ISPE Critical Utility CoP Steering Committee, and the Parenteral Drug Association. He has been an ISPE member since 2018.
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to...
A temperature sensor in a medical autoclave is typically calibrated once a year. If the sensor proves to be inaccurate, all batches produced since the last calibration must be evaluated. Endress+Hauser has developed a self-calibrating sensor that automatically verifies its accuracy during each sterilization batch. This article describes a case study at the Merck Healthcare KGaA sterile...