Joseph Franchetti
JAF Consulting Inc
Managing Consultant
As Managing Consultant for JAF Consulting Incorporated, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, HIPAA, and Computer System Validation in regulated environments such as Pharmaceutical, Life Science, Healthcare, and Medical Device. For over thirty years, Mr. Franchetti has been involved with the development, purchase, installation, operation, audit, and maintenance of computerized systems used in all phases of drug development and manufacturing. In addition, Joe has over thirty years of progressive experience in Quality Assurance, Information Technology and Data Management.
He has extensive experience with all aspects of computer systems validation and compliance and is involved with industry groups and publications such as the ACDM Clinical Research-CSV Working Party, DIA PEACH publication on Computerized Systems used in Clinical Trials, and has also participated in a few GAMP Special Interest Groups. Joe is currently on the planning committee to write on a book on Data Integrity with colleagues form the Society of Quality Assurance.
Joe is currently a Board Member as a Director for the Society of Quality Assurance; Chair of the Training Sub-Committee for the Society of Quality Assurance’s Computer Validation Information Technology Compliance Specialty Section, where he is responsible for the training programs related to Data Integrity and Computer Systems Validation. He is also recognized in the inaugural class of Distinguished Speaker by the SQA Learning Foundation in 2017.
Joe is experienced in Project Management; Data Integrity, Cloud Computing, Quality Systems Implementation, Disaster Recovery / Business Continuity, Pharmacovigilance and Drug Safety, Instructional Design, Vendor / Supplier and Compliance Audits; Computer System Validation; US & International Regulations and Standards (GLP, GMP, GCP, ISO Standards, HIPAA, Sarbanes-Oxley (SOX), 21 CFR Part 11, European Union, Japanese Ministry of Health Labor and Welfare); Electronic Records, Electronic and Digital Signatures, Information Technology; Quality Assurance; Quality Management Systems, Electronic Data Management; Laboratory Robotics; Laboratory Operations and Analysis; Drug Discovery; Informatics; Data Warehousing Documentation Development and Content Management.
He has extensive experience with all aspects of computer systems validation and compliance and is involved with industry groups and publications such as the ACDM Clinical Research-CSV Working Party, DIA PEACH publication on Computerized Systems used in Clinical Trials, and has also participated in a few GAMP Special Interest Groups. Joe is currently on the planning committee to write on a book on Data Integrity with colleagues form the Society of Quality Assurance.
Joe is currently a Board Member as a Director for the Society of Quality Assurance; Chair of the Training Sub-Committee for the Society of Quality Assurance’s Computer Validation Information Technology Compliance Specialty Section, where he is responsible for the training programs related to Data Integrity and Computer Systems Validation. He is also recognized in the inaugural class of Distinguished Speaker by the SQA Learning Foundation in 2017.
Joe is experienced in Project Management; Data Integrity, Cloud Computing, Quality Systems Implementation, Disaster Recovery / Business Continuity, Pharmacovigilance and Drug Safety, Instructional Design, Vendor / Supplier and Compliance Audits; Computer System Validation; US & International Regulations and Standards (GLP, GMP, GCP, ISO Standards, HIPAA, Sarbanes-Oxley (SOX), 21 CFR Part 11, European Union, Japanese Ministry of Health Labor and Welfare); Electronic Records, Electronic and Digital Signatures, Information Technology; Quality Assurance; Quality Management Systems, Electronic Data Management; Laboratory Robotics; Laboratory Operations and Analysis; Drug Discovery; Informatics; Data Warehousing Documentation Development and Content Management.