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, GMPs, 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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