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I am responsible for managing multiple key departments, including: Human Resources, Legal, Marketing and Accounting, ensuring that each one is operating effectively and in alignment with JAF’s strategic goals.
My speciality is contract law and my professional focus is primarily in the legal field, with a particular emphasis on contract negotiation and management.
The most rewarding aspect of working at JAF is being part of the JAF Team. This group of talented professionals brings a wealth of regulatory expertise that I learn from daily. They are a pleasure to collaborate with, and their support makes every day at work enjoyable.
North Carolina
Southern New Jersey
My core values are integrity, respect, compassion, courage, and gratitude.
I am a custom cookie baker/decorator in my free time. I also love to read, do puzzles, go to the beach and travel.
I volunteer within my community in various capacities from being a board member on our POA, to managing local blood drives for the American Red Cross, and giving back through a local women’s business owner group I am a member of.
As a Social Media/ Marketing Intern, my role is to assist in developing and implementing social media strategies to increase brand awareness, drive engagement, and generate leads for the company. I also support in managing and growing the company’s social media presence on various platforms such as LinkedIn and Twitter.
The most fulfilling part of working with JAF Consulting is making a tangible impact. As a Social Media/ Marketing Intern, I have the opportunity to see the direct impact of my work on the success of the company. Whether it is driving website traffic, generating leads, or increasing JAF’s awareness, I can see the results of my efforts firsthand. Overall, the most fulfilling part of working with JAF Consulting is the opportunity to learn, grow, and make a meaningful impact through creative expression and collaboration.
Greensboro, North Carolina
New Jersey
Reading and walking various trails with my dog.
Joseph A. Franchetti is the President of JAF Consulting, Inc., where he has been leading a team of compliance consultants in the Life Science and Pharmaceutical industries for over 20 years. Individually, Mr. Franchetti has addressed the Life Science, Pharmaceutical, and Medical Device Industries needs in the area of FDA Regulatory Compliance of Computerized Systems. In addition, Mr. Franchetti has over thirty years of progressive experience in information technology and data management in the life science and pharmaceutical industries. As a former Manager of Automated Computer Systems, he was responsible for the regulatory compliance, operation, and maintenance of all data systems for the research and development division of a major generic pharmaceutical company. He is also experienced in the areas of Laboratory Robotics and Automated Systems, where he led multiple project teams in developing automated systems for the testing of pharmaceutical products. In the early 90’s, he was given the “Pioneer in Laboratory Robotics” Award; a peer-recognized award for the development of new applications and designing innovative and unique solutions to technical problems.
He has extensive experience with all aspects of computer systems validation and compliance and was involved with the GAMP Special Interest Group on Laboratory Systems, and is currently the Training Chairperson for the Society of Quality Assurance’s Computer Validation Initiative Committee.
Joe is experienced in Project Management; Quality Systems Implementation, Pharmacovigilance and Drug Safety, Instructional Design, Vendor / Supplier and Compliance Audits; Computer System Validation; US & International Regulations and Standards (cGLPs, cGMP, & cGCPs, ISO Standards, Sarbanes-Oxley (SOX), 21 CFR Part 11, European Union, Japanese Ministry of Health Labor and Welfare); 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.
JAF Consulting, Inc. provides Validation Program Planning & Development, Validation Project Management & Execution, E-Rec /E-Sig Planning and Remediation, Training Program Development & Execution, SOP Development and Compliance Auditing and Assessment services to its clients. With his diverse experience, Mr. Franchetti will share his knowledge of managing large-scale projects, and can effectively communicate on both technical and regulatory issues.
My Roles and Responsibilities with JAF Consulting Inc. expand in the following areas:
Regulatory Compliance Support:
Interpreting FDA regulations, such as 21 CFR Part 11, Part 210/211, and Part 820, and helping ensure your validation activities meet these requirements.
Supporting preparation for FDA audits by reviewing documentation and identifying gaps.
Validation Process Assistance:
Assisting with drafting and reviewing validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
Providing input on creating validation master plans and test scripts to ensure thorough coverage of systems or processes.
Quality Documentation:
Reviewing or helping draft SOPs, and risk management plans.
Ensuring documents align with both internal standards and regulatory expectations.
Data Integrity & Systems Compliance:
Offering guidance on data integrity principles, particularly around ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
Evaluating systems for Part 11 compliance, focusing on electronic records and signatures.
Audit Readiness & Gap Analysis:
Assisting in mock audits to assess validation processes and documentation readiness.
Conducting or supporting gap analyses against FDA guidance and industry best practices.
Computer Systems Validation, Equipment Validation, and Manufacturing Systems commissioning and qualification.
Client Satisfaction and JAF Team Appreciation.
Rhode Island
India and the United States
Accuracy: Providing reliable, detailed, and precise information to ensure your work aligns with regulatory and quality standards.
Integrity: Upholding transparency and honesty in the guidance and resources I offer, ensuring compliance with ethical and regulatory principles.
Collaboration: Partnering with you to understand your specific needs, challenges, and goals, so my support is practical and relevant.
Adaptability: Tailoring solutions and approaches to fit the unique demands of your projects, whether drafting a validation plan or troubleshooting compliance issues.
Continuous Improvement: Staying updated on regulatory trends and best practices to ensure the information and tools I provide are current and effective.
Accountability: Taking responsibility for the accuracy and utility of my contributions, ensuring they add value to your processes.
Writing, Pickleball, Volleyball, Cricket (analysis)
I volunteer at a local Cat Sanctuary.
