Inquiries: info@jafconsulting.com
logo
logo
logo
logo
  • About Us
  • Services
    • Computer Systems Validation
    • Education & Training
    • General Consulting
    • GxP Compliance
    • Inspection Readiness Program
    • Nutraceutical Compliance
    • REDCap Validation
  • Happenings
    • News
    • Events
  • Resources
  • Vendor Alliance
  • Contact Us
    • Careers
  • Work with Us
  • Search

News

News

December 23, 2024

2024 Holiday Message


0 Comments1 Minutes

News

April 18, 2024

Listen to Joe Franchetti on the SQA Interviews Podcast


0 Comments1 Minute

News

March 20, 2024

Listen to Joe Franchetti on the Let’s Talk Quality Podcast


0 Comments1 Minute

News

March 6, 2024

Embracing Excellence: A Journey Through SQA’s Ruby Anniversary Year


0 Comments9 Minutes

News

January 25, 2024

Celebrating Excellence: Gina Tucker Assumes the Role of President at NCARSQA


0 Comments3 Minutes

News

January 4, 2024

Joseph Franchetti Begins as Board President of the Society of Quality Assurance


0 Comments2 Minutes

EventsNews

October 15, 2023

Attending ISPE 2023!


0 Comments2 Minutes

EventsNews

August 14, 2023

SQA Board Chat for Members hosted by Joe Franchetti


0 Comments1 Minutes

ResourcesNews

June 14, 2023

Review of Warning Letters presented by JAF Consulting CEO Joe Franchetti


0 Comments3 Minutes

News

May 10, 2023

JAF Consulting Secures Its Mark


0 Comments1 Minutes

News

March 6, 2024

Embracing Excellence: A Journey Through SQA’s Ruby Anniversary Year


Read More

News

January 25, 2024

Celebrating Excellence: Gina Tucker Assumes the Role of President at NCARSQA


Read More

News

January 4, 2024

Joseph Franchetti Begins as Board President of the Society of Quality Assurance


Read More

EventsNews

October 15, 2023

Attending ISPE 2023!


Read More

EventsNews

August 14, 2023

SQA Board Chat for Members hosted by Joe Franchetti


Read More

ResourcesNews

June 14, 2023

Review of Warning Letters presented by JAF Consulting CEO Joe Franchetti


Read More

News

May 10, 2023

JAF Consulting Secures Its Mark


Read More

News

December 21, 2022

Joseph Franchetti Appointed Vice President of SQA


Read More

NewsCareers

November 18, 2022

Hiring Compliance Consultant


Read More

News

October 30, 2022

JAF Exhibits at ISPE 2022 in Orlando Florida


Read More

Loading…

Let's get to work.

Get Started

We're an agile, smart, and proud partner to life science companies specializing in quality and regulatory compliance solutions.

Connect with Us:

Get in Touch:

info@jafconsulting.com
(856) 241 1900

Headquarters:

PO Box 15584
Wilmington, NC 28408

Serving clients worldwide.

Learn More:

Work with Us
About Us
Our Services
News & Events
Help & Resources
Contact Us

Get StartedBook an Intro

© 2023 – JAF Consulting™ • All Rights Reserved • Built by Eric Michael

Privacy Preference Center

Privacy Preferences

Rochelle Merino

Senior Vice President of Operations
Connect on LinkedIn →

How would you describe your role and responsibilities within the organization?

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.

What’s your specialty?

My speciality is contract law and my professional focus is primarily in the legal field, with a particular emphasis on contract negotiation and management.

What is the most fulfilling part of working with JAF Consulting?

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.

Where do you live?

North Carolina

Where did you grow up?

Southern New Jersey

What are your core values?

My core values are integrity, respect, compassion, courage, and gratitude.

What are your hobbies?

I am a custom cookie baker/decorator in my free time. I also love to read, do puzzles, go to the beach and travel.

How do you show up in your community?

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.

Gina M. Tucker

Senior Compliance Consultant
Connect on LinkedIn →

How would you describe your role and responsibilities within the organization?

Provide consultative services in the areas of GLP, GCP and GMP processes, auditing, regulatory training, computer system validation, software development life cycle, software testing processes and project management

What’s your specialty?

GLP and CSV.

What is the most fulfilling part of working with JAF Consulting?

Working with amazing team members and fantastic clients.

Where do you live?

Walkersville, Maryland

Where did you grow up?

Long Island, NY

What are your core values?

Family, Integrity, Honesty

What are your hobbies?

obedience/agility training with my dog, baking, reading.

Seth Cook

Business Development Associate
Connect on LinkedIn →

How would you describe your role and responsibilities within the organization?

My main roles and responsibilities are to generate/qualify leads, create proposals, follow up with clients and develop our partnership program.

What’s your specialty?

My specialty and focus professionally lie in lead generation and qualification. I excel in identifying potential clients who align with our company’s ideal customer profile, initiating meaningful conversations to generate interest in our products or services, and carefully qualifying leads to ensure they are a good fit for what we offer.

What is the most fulfilling part of working with JAF Consulting?

Working for a company that cares about our clients and how our work affects their end goal.

Where do you live?

Carolina Beach, NC

Where did you grow up?

Concord, NC

What are your core values?

My personal core values are honesty, reliability and trust.

What are your hobbies?

In my free time I enjoy going to the gym and spending time outdoors.

How do you show up in your community?

I show up in my community by helping the elderly in my neighborhood.

Patti Bruce-Anderson

Compliance Consultant
Connect on LinkedIn →

How would you describe your role and responsibilities within the organization?

Technical writing and ensuring compliance throughout all project documentation.

Do you have a specialty or focus, professionally?

GLP and GCP projects.

What is the most fulfilling part of working with JAF Consulting?

Working with extremely smart people.

Where do you live?

Missouri

Where did you grow up?

New Jersey

What are your core values?

Integrity, accountability, diligence, perseverance and discipline.

What are your hobbies?

Reading, painting and hiking

How (and where) do you show up in your community?

New to this community, no volunteer work yet.

Victoria Sims

Social Media/Marketing Intern
Connect on LinkedIn →

How would you describe your role and responsibilities within the organization?

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.

What is the most fulfilling part of working with JAF Consulting?

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.

Where do you live?

Greensboro, North Carolina

Where did you grow up?

New Jersey

What are your hobbies?

Reading and walking various trails with my dog.

Joe A. Franchetti

President / Managing Partner
Connect on LinkedIn →

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.

Gaurav Kumar

Senior Compliance Consultant
Connect on LinkedIn →

How would you describe your role and responsibilities within the organization?

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.

Do you have a specialty or focus, professionally?

Computer Systems Validation, Equipment Validation, and Manufacturing Systems commissioning and qualification.

What is the most fulfilling part of working with JAF Consulting?

Client Satisfaction and JAF Team Appreciation.

Where do you live?

Rhode Island

Where did you grow up?

India and the United States

Do you know what your core values are? If so, drop them here.

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.

What are your hobbies?

Writing, Pickleball, Volleyball, Cricket (analysis)

How (and where) do you show up in your community?

I volunteer at a local Cat Sanctuary.

GET IN TOUCH

SCHEDULE AN INTRO


REQUEST A FACT SHEET
Which fact sheet are you interested in?
Use the arrows to scroll and make a selection. You'll be redirected on submission.
Field is required!
Field is required!
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Where should we send it?
Enter your email address:
Field is required!
Field is required!
GO

ENTER-TO-WIN

Enter to win in our monthly drawing!

One lucky Grand Prize Winner will receive a free $100 USD Amazon Gift Card. Runners Up (2) will receive a Complementary Web Training (30min) or Complementary Consultation (30min).
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Email Address:
Field is required!
Field is required!
Submit
GXP ASSESSMENT
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Where are you located?
Field is required!
Field is required!
How would you like to collaborate?
  • - select a option -
  • On-site
  • Virtually
  • Hybrid
Field is required!
Field is required!
Email:
Field is required!
Field is required!
Phone:
Invalid phonenumber!
Invalid phonenumber!
Which services are you interested in?
Check all that apply.
Field is required!
Field is required!
What type of GLP services do you need?
Select all that apply.
Field is required!
Field is required!
What type of GLP audits do you need conducted?
Select all that apply.
Field is required!
Field is required!
What other GLP auditing needs do you have?
Field is required!
Field is required!
How many GLP audits do you need conducted? And/or, on what timeline?
Field is required!
Field is required!
What type of GLP training do you need?
Field is required!
Field is required!
When do you need GLP training to commence?
Field is required!
Field is required!
Briefly describe the GLP-related needs or specific resource assistance you're looking for:
Field is required!
Field is required!
What type of GCP services do you need?
Select all that apply.
Field is required!
Field is required!
What type of GCP auditing is required?
Select all that apply.
Field is required!
Field is required!
How many GCP audits do you need conducted? And/or, on what schedule?
Field is required!
Field is required!
Please describe your 'other' GCP Auditing needs:
Be as detailed as possible.
Field is required!
Field is required!
What type of GCP training do you require?
Please be as detailed as possible.
Field is required!
Field is required!
When do you need GCP training to commence? And/or, at what frequency?
Field is required!
Field is required!
Please detail any additional or 'other' GCP needs you may have, if any:
Optional.
Field is required!
Field is required!
What computer system validation (CSV) services do you need?
Select all that apply.
Field is required!
Field is required!
What type of CSV auditing services do you need?
Field is required!
Field is required!
What types of systems need to be validated?
Field is required!
Field is required!
How many systems need to be validated?
Field is required!
Field is required!
How many CSV audits do you need? And, on what schedule?
Field is required!
Field is required!
What type of products or systems are you looking for?
Field is required!
Field is required!
Have you already begun your search?
For the product or system.
Field is required!
Field is required!
Are you looking to replace an existing/active product or system?
Field is required!
Field is required!
Please share any additional information as it relates to your CSV needs:
Field is required!
Field is required!
Submit
REDCAP ASSESSMENT
Is your system validated?
Field is required!
Field is required!
Is your system used to create, modify, maintain, store, archive, retrieve or transmit patient Protected Health Information (PHI) under Health Insurance Portability and Accountability Act (HIPAA)?
Field is required!
Field is required!
Does your system use Electronic Records?
Field is required!
Field is required!
Are Electronic Signatures used?
Field is required!
Field is required!
Are the records in electronic form created, modified, maintained, archived, retrieved, or distributed by a computer system?
Field is required!
Field is required!
Are the signatures executed in the system a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature?
Field is required!
Field is required!
Are records protected against intentional or accidental modification or deletion?
Field is required!
Field is required!
Do you have a strategy defined or documented for the backup, restore and retention process? If so, has it been tested?
Field is required!
Field is required!
Does your system have access control?
Field is required!
Field is required!
Do you have policies and procedures to ensure both internal and external security?
Field is required!
Field is required!
Does your system maintain an audit trail that is readily available for an inspection?
Field is required!
Field is required!
Does the system ensure that only authorized individuals can use the system?
Field is required!
Field is required!
Does the system verify that an individual has the authority to electronically sign a record before allowing the individual to do so, or deny access to invalid users?
Field is required!
Field is required!
Do you have documentation to show that people who use the system have the education, training, and experience to perform their assigned tasks?
Field is required!
Field is required!
Do you have a Change Control procedure in place for System upgrades?
Field is required!
Field is required!
Are policies and processes established to certify that an electronic signature is the legally binding equivalent of the signer's handwritten signature?
Field is required!
Field is required!
Is your system used to electronically sign, electronically approve, or electronically archive data-containing regulatory submission documents for investigational or marketing applications to Health Authorities?
Field is required!
Field is required!
Does your system have any impact with respect to patient safety or Product Quality or Business Continuity?
Field is required!
Field is required!
Does your system directly affect the design, conduct, performance, auditing, recording, analyses, and report monitoring of adverse events in clinical studies of investigational products?
Field is required!
Field is required!
Is your system used for collecting, assessing, monitoring, and reporting adverse events for drug products?
Field is required!
Field is required!

Based on your responses, you may be at risk for an FDA audit. But we can help!

Enter your information below and a member of our REDCap team will reach out to assist with making validation simple and seamless.

Thanks for completing the assessment.

Enter your information below and a member of our REDCap team will reach out to discuss ways we may be able to assist in making validation simple and seamless.
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Email:
YOUR@EMAIL.COM
Field is required!
Field is required!
Is there anything else you'd like to share?
Optional.
Field is required!
Field is required!
SUBMIT
WORK WITH US
First Name (Legal):
First Name
Field is required!
Field is required!
Last Name (Legal):
Last Name
Field is required!
Field is required!
Email:
you@youremail.com
Field is required!
Field is required!
Phone Number:
+1 000-000-0000
Field is required!
Field is required!
Desired Position:
  • - select a option -
  • Account Representative (Sales)
  • Clinical Practice Auditor
  • Computer Validation Auditor
  • General Compliance Expert
  • Lab Practice Auditor
  • Manufacturing Practice Auditor
- select a option -
Field is required!
Field is required!
Desired Term:
  • - select a option -
  • Contract
  • Full-Time (Regular)
  • Part-Time (Regular)
- select a option -
Field is required!
Field is required!
Cover Letter:
Upload your cover letter. Max Size: 10MB
Upload your documents...
Field is required!
Field is required!
Resume:
Upload your resume. Max file size: 10MB.
Upload your documents...
Field is required!
Field is required!
Is there anything else we should know when reviewing your application?
Have we met before? Did someone refer you? You can leave all of that here.
Field is required!
Field is required!
Submit