Ernesto Alfonso
- Role
- Pharma Consulting Group International (Pcgi) at Pharma Consulting Group International Pcgi
- Location
- Miami, FL, US
- LinkedIn followers
- 500 followers
About Ernesto Alfonso
With over 35 years of leadership in the pharmaceutical, biotechnology, and medical device…
Experience
Pharma Consulting Group International (Pcgi)
Pharma Consulting Group International Pcgi
Present
Education
New Jersey City University
BS, Biology & Chemistry
1982 — 1986
Fairleigh Dickinson University
MSc, Biology / Pharma Management
1998 — 2000
Skills
- Good Laboratory Practice (Glp)
- Process Improvement
- Verification and Validation (V&V)
- Medical Devices
- Six Sigma
- Quality Auditing
- Aseptic Processing
- Capa
- Lean Compliance
- U.s. Title 21 Cfr Part 11 Regulation
- 21 Cfr Part 11
- Regulatory Requirements
- Auditing
- U.s. Food and Drug Administration (Fda)
- Lean Manufacturing
- Quality Assurance
- Quality Management
- Compliance Remediation Plans
- Technology Transfer
- Quality Control
- Gmp
- Compliance
- Pharmaceutical Industry
- Fda
- Cross-Functional Team Leadership
- Regulatory Affairs
- Lifesciences
- Validation
- Quality System
- Quality Systems
- V&V
- Regulatory Compliance
- Corrective and Preventive Action (Capa)
- Training
- Glp
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