Mary Foster
Senior Pharmaceutical Quality Executive | US Pharmacopeia Expert
- Role
- Chair, Expert Committee, Packaging, Storage & Distribution at US Pharmacopeia
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Mary Foster
Accomplished quality executive with demonstrated success in maintaining high levels of quality and compliance in the manufacturing of sterile, oral, and topical pharmaceuticals. More than 20 years of experience at Catalent Pharma and its predecessor companies. 15 years of service to the US Pharmacopeia committees and recognized expert in packaging and storage of drug product. PharmD and BS Pharmacy degrees from University of Kentucky. Specialties: Pharmaceutical Industry, Contract Development and Manufacturing Organization, CDMO, Compliance, Quality Assurance, QA, Quality Control, QC, Quality Management System, QMS, Good Manufacturing Practices, GMP, Good Laboratory Practice, GLP, GxP, FDA, ANVISA, MHRA, EMA, Regulatory Affairs, Sterile, Topical, Oral Solid Dose, US Pharmacopeia, USP, CAPA, Deviation, Technical Transfer, Validation, Packaging, Storage, Distribution, Import, Export, Manufacturing Operations, Supply Chain, ANDA, NDA, OTC, Investigations, Restructuring, Site Closure, Site Establishment, Risk Assessment, Risk Management, Risk Mitigation, DEA, SOP, Audit, Complaint Handling, Continuous Improvement
Experience
Chair, Expert Committee, Packaging, Storage & Distribution
Jan 2010 — Present · Rockville, MD, US
Education
University of Kentucky
Doctor of Pharmacy (PharmD), Pharmacy
1979 — 1983
University of Kentucky
Bachelor of Science (BS), Pharmacy
1979 — 1983
Western Kentucky University
BFA, Area of Concentration, Painting
1972 — 1976
Skills
- Gxp
- Quality Auditing
- Aseptic Processing
- Capa
- Pharmaceutics
- Standard Operating Procedure (Sop)
- U.s. Title 21 Cfr Part 11 Regulation
- 21 Cfr Part 11
- Regulatory Requirements
- U.s. Food and Drug Administration (Fda)
- Hplc
- Technology Transfer
- Gmp
- Biopharmaceuticals
- Change Control
- Pharmaceutical Industry
- Sop
- Fda
- Cleaning Validation
- Cross-Functional Team Leadership
- Trackwise
- Regulatory Affairs
- Validation
- Regulatory Submissions
- Quality System
- V&V
- Computer System Validation
- Corrective and Preventive Action (Capa)
- Glp
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