Joseph Franchetti
- Role
- Managing Consultant at Jaf Consulting, Inc
- Location
- Wilmington, NC, US
- LinkedIn followers
- 500 followers
About Joseph Franchetti
Quality Assurance, Computer Validation and Regulatory Services: Over 25 years of…
Experience
Managing Consultant
Jan 1995 — Present
Performed numerous validation compliance audits to assess systems against current regulatory expectations along with company compliance policies. Reviewed and assessed complete validation documentation, standard operating procedures and organizational policies to document the gaps in processes and validation effort. Recommended policy change, procedure revisions and, additional testing to bring the systems into regulatory & corporate compliance Managed site wide computer system validation compliance project for major global pharmaceutical client with a diverse senior management project team. Project entailed remediation of Laboratory and Manufacturing Equipment Computer Systems, Building Automation Systems, and 21 CFR Part 11. The Project also included harmonization of site procedures in Computer System Validation, Change Control, 21 CFR Part 11 Policy, & IT infrastructure. Responsibilities included to Documentation Preparation & Review and Project Planning & Updates.
Education
Bishop Eustace Preparatory School
Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Saint Joseph's University
B.S., Chemistry
1985 — 1989
Skills
- Pharmaceutical Industry
- Clinical Research
- Pharmaceutics
- Laboratory
- Glp
- Program Management
- R&D
- Manufacturing
- Document Management
- Gmp
- Technology Transfer
- Testing
- Quality Management
- Team Leadership
- Gxp
- Software Documentation
- Cross-Functional Team Leadership
- Medical Devices
- Capa
- Quality Control
- Clinical Development
- Quality Assurance
- Sdlc
- Management
- Change Control
- Time Management
- Auditing
- Validation
- Ctms
- 21 Cfr Part 11
- Regulatory Affairs
- Delivering Technical Training
- CRO
- Drug Discovery
- Quality Auditing
- Regulatory Requirements
- V&V
- Computer System Validation
- Fda
- Project Management
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