Thomas Macek

PBE Expert

Pharmaceuticals | Biotech | Nutraceuticals | Cosmetics | Hospitals & Pharmacies Clean Rooms | Medical Devices | Foods Independent Compliance Review & Audit (cGMP, ISO14644, ASME-BPE, HSE): o Sanitary process design & engineering (PFD, P&ID, layout & technical specifications) o Classified cleanrooms functional analysis of (A, B, C, D, ISO5-8) o Physical & mechanical segregation requirements o Cross flow & contamination risk analysis o Aseptic design analysis of cleanrooms, equipment, & products o Biological containment facilities design (BSL2, 3, 4) o High potent facilities design (HP1-5, OEL: 1@+1000 µg/m3) o Risk analysis assessment, & mitigation (FMEA, ATEX) o Risk management tools for prevention, disinfection, biodecontamination, sanitation, and maintaining levels of protection. Construction & project management (EPCMV) o Supervision of delivery, Installation, Commissioning (FAT, SAT) & start-up o On site construction & installation works follow-up & Benchmark o Approval of validation protocols and reports of DQ, IQ, OQ o Management of predictive, preventive& routine maintenance o Management of calibration, sampling & change control programs o cGMP training. cGMP Engineering Compliance & Project Manager C. 1.514-616-2692 | www.pharmabioeng.com http://www.pharmabioeng.com/index.php?page=home http://www.pharmabioeng.com/index.php?page=compliance http://www.pharmabioeng.com/index.php?page=project-management PBE, Your c-GMP Regulation & Engineering Compliance & PM Partner