Mary M. Email & Phone Number

Georgia Tech Biomedical Engineering MS graduate with background in Medical Device and Biopharmaceuticals. Experience in the areas of Quality and Validation includes:- User complaint remediation- Issue Impact assessments and Released Product Investigation- CAPAs- GMP Regulations- ICH and FDA Guidelines, MDSAP and FDA Observation Responses- Medical Device Quality Management Systems- Good Documentation Practices/Quality Documentation Review/Electronic Record Management- ISPE Guidance on Commissioning and Qualification Best Practices- Process Validation and Cleaning Validation- Data Integrity (GAMP5)- FMEA Risk assessments- Environmental Monitoring- Deviation Management