About Joan Sutera
Joan Sutera is an experienced Quality Professional, accomplished pharmaceutical/biopharmaceutical Professional and Corporate Global Auditor. She has extensive knowledge of cGMP, US FDA, EMA, TGA, USDA, USP, ICH, EP, JP, ISO, Medical Devices, CBER and CDER compliance & industry trends. In addition, she has been a recognized leader and team player with strengths that include a consistent record of attention to detail, process improvement, well developed interpersonal and communication skills and audit strategy.
Joan has a reputation for logical, pragmatic & diplomatic thinking in assessment and resolution of issues. In addition, she has an excellent understanding of the drug development process, both small and large molecules, with the commercialization of the novel medicinal products as well as the maintenance of Quality Systems to satisfy the ever increasing global regulatory requirements. Also, has proven experience with the ability to identify risk & work strategically with management to resolve complex compliance issues and mitigate high risks to facilities & microbiological concerns.
Consulting Services include CRO/vendor monitoring & qualifications (including animal health & animal vaccines), SOP development, compliance gap analysis, NDA reviews, CAPA management, conducting mock FDA GMP inspections, PAIs, & personnel training.
Areas of expertise include but are not limited to:
- Aseptic Manufacturing Processing & Risk Mitigation
- Microbiology Laboratories
- Compendium tests, i.e. Sterility Test, Endotoxin, Microbial Limits
- Environmental Monitoring Programs (including water & personnel monitoring)
- Microbial Contamination Control
- Laboratory Investigations/OOS
- cGMP Compliance and Quality Systems
- GLP Training
- Aseptic Processing
- Microbiology-related project management (start-up and compliance remediation)
- Microbiological Test Methods Validation
- Facility and Equipment Validation Protocols
- Laboratory Management
- Technically-driven project management
- Mock Audits
- Gap Assessments
Specialties include Aseptic Processes, Biologics, Vaccines, Microbiology, GxP and Training