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Joseph Franchetti
JAF Consulting, Inc
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. In addition, Joe has over thirty years of progressive experience in 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 the Training Chairperson 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; Vice Chair for the SQA Education Committee; and Chair of the Quality Assurance Consulting Support Specialty Section. 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, 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.