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Ken W. Schawel
Senior Consultant

Mr. Kenneth Schawel, Senior Consultant, Globepharm Consulting, has over thirty-five years experience in the pharmaceutical, device and biologics manufacturing industries. He has worked in QA/QC/RA in small and large volume injectable facilities, sterile medical sets and device facilities, tablet and capsule facilities, and API manufacturing. He has specific experience in aseptic fill, terminal sterilization (steam, radiation, ETO, and dry heat), environmental monitoring programs, component cleaning, laboratories, validation, GMP’s, quality systems, new product development, and pharmacy compounding. Mr. Schawel has designed pharmaceutical manufacturing facilities and critiqued the designs of others.

He has worked both domestically and internationally and has successfully directed a number of consent decrees and recall situations both as an employee and consultant. He has been involved in both creating new plant designs and in the validation and start up of new manufacturing systems or new manufacturing plants. Mr. Schawel has developed SOP systems for small scale device and clinical manufacturing companies.

As a consultant Mr. Schawel has created quality systems, master validation plans, has managed the validation of a large volume product line, has built media fill programs, and has taught sterilization, aseptic fill, and in house basic microbiology courses. He has also given lectures on environmental monitoring programs and specialized component cleaning systems.
He has worked for more than 25 companies as a consultant and five corporations as a full time employee. He is a member of PDA and is intimately familiar with both domestic US-GMPs and international GMPs.

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