subject: human Behavior In Cleanrooms And Controlled Environments From Globalcompliancepanel [print this page] Description:
Most medical products, comprising biologics, devices, drugs and diagnostics are manufactured under strictly controlled conditions in cleanrooms. To keep contaminants out of products, cleanrooms are designed, built, validated and operated to exact specifications.
However, despite the best care, such facilities can overlook the primary source of contaminants humans. Human care and behavior also need to strictly and consistently monitored and controlled in order to get the best results out of cleanrooms.
This webinar helps participants understand ways by which they can identify good and bad cleanroom behaviors, retain or improve upon good ones and discard the bad ones. This training session will help them:
oGet in-depth understanding of cleanroom contaminants
oAchieve satisfactory inspections more easily
oAvoid product recalls
oEstablish best personnel behavior and eliminate bad habits
oGet higher assurance of new medical product approvals
Charles Gyecsek is formerly of Hoffman LA Roche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career, Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in three separate facilities.
Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses.
Charles is currently President of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals, diagnostics, devices, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers.
