Aseptic Processing (Fill Finish) and Regulatory Compliance:
Worldwide Health Authority regulatory compliance wit experience supporting Sterile Fill / Lyo Suite design, vendor selection, FAT and SAT, IOPQ, intervention risk assessments, smoke studies, Process Validation (Aseptic Process Simulation and Process Performance Qualification) and into commercial operation and Health Authority PAS (FDA, MHRA, PMDA, TGA etc).
Experience with the cleanroom design (Grade D to A), area risk assessments for microbiological sampling plan for qualification and routine monitoring. Lead disinfection efficacy studies, dry time studies, media fill investigations, deviation investigations and setup forensic lab for internal particulate monitoring and investigation support.
Experienced with depyrogenation, steam sterilization, VHP, Single Use System design / qualification, sterile filtration / filter integrity testing, filling, loading, lyophilization, unloading, capping, coding, terminal sterilization, 100% visual Inspection and labeling.
CMDO Management:
Experience directly managing technical operation with the CMDO. Day to day production and issues (supply, compounding, filtration, fill, inspect) and related change controls / deviations / CAPAs and ongoing risk assessments / product monitoring. Performed sterile product technical transfer across the US, intercontinental and within site. Supported vendor selection, budgeting, allocation and long term product planning.
Formulation:
Experience formulating Nasal, Inhalation, Oral Liquid and Solid Dosage Forms from pre clinical to registration batches and commercial support.