Lindsey M Schwierjohann
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Detailed Analysis
Schwierjohann takes a meticulous yet comprehensive approach to audits, scrutinizing every aspect of the manufacturing process. She is particularly attentive to the ways in which a facility ensures the consistency of their product quality, from their adherence to established production phase time limits to their procedures for testing and releasing drug products.
FDA investigator Lindsey M Schwierjohann has shown a particularly strong focus on the areas of production parameters, testing and release of drug product, microbiological contamination prevention, batch production and control record keeping, and sterilization approaches. Schwierjohann also pays close attention to regulations regarding the adequacy of environmental monitoring and cleaning procedures within aseptic processing areas, operator adherence to SOPs, and the investigation of batch failures and discrepancies. He is strict but fair, paying diligent attention to safety and consistency in quality control.
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