API and aseptic fill-finish production monitoring and microbial control
cGMP compliance / cGMP Annual Training
Cleaning validation / Method Validation
Disinfection, sterilization and the use of biological indicators
Environmental monitoring
Facility design and qualification
Investigations of laboratory and production of microbial excursions and OOS Results and aberrant data
Laboratory audits - Microbiology / Chemistry
Microbiology / Chemisrty development (method and protocol)
Pharmacopoeial compliance
Validation and IQ/OQ/PQ - Process Analytical Technology (PAT)
Process development
Regulatory audit response (i.e., FDA warning letters)
Sterility assurance and aseptic processing