Registration is now open. RSVP and join the cohort via the link below:


About the Program:

In today’s regulated environments, computer systems play an integral role in maintaining data integrity, ensuring patient safety, and compliance with regulatory requirements. This comprehensive 3-hour webinar is designed to provide a foundational understanding of computer system validation (CSV) within Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) environments.

Through a combination of expertly led discussions, interactive opportunities, and practical examples, participants will gain insights into the essential concepts, principles, and real-world applications of CSV. Whether you are new to CSV, or are seeking a refresher update, this webinar will provide information necessary to positively contribute to validation efforts in your organizations.

This webinar will discuss regulatory frameworks and guidelines, lifecycle approach to CSV, risk assessment and mitigation, validation documentation and deliverables, validation testing approaches, data integrity and audit trails, and change management.

Participants will have the opportunity to engage in interactive discussions, ask questions, and gain insights from the presenters’ real-world experiences.

Learning Objectives:

At the end of this webinar, participants should:

  • Have a clear understanding of key requirements of computer system validation for GLP, GCP, and GMP environments.
  • Develop meaningful tools and deliverables to complement your organization’s CSV program.
  • Be aware of the common pitfalls and challenges faced by organizations.

Who Should Attend?

This webinar will benefit Quality Assurance (QA), Operations, and Information Technology (IT) professionals that lead and participate in computer system validation (CSV) projects. Personnel include but are not limited to QA, IT, System Administrators, System Owners, and Management.

Meet the Presenters:

Joe Franchetti

CEO & President, JAF Consulting

As CEO, President, and Managing Consultant for JAF Consulting Incorporated since 2001, 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 Healthcare, Pharmaceutical, Life Science, and Medical Device. For over thirty years, Mr. Franchetti has been involved with developing, purchasing, installing, operating, auditing, and maintaining computerized systems used in all drug development and manufacturing phases. In addition, Joe has over thirty-five years of progressive experience in information technology and data management.

He has extensive experience with all aspects of regulatory compliance especially in computer systems validation. Joe is involved with many industry groups and publications such as SQA, ISPE, and DIA, and has also participated in a few GAMP Special Interest Groups.

Joe is currently the Vice President of the Society of Quality Assurance and will be President in 2024.  He has held many leadership positions in SQA in the Computer Validation Information Technology Compliance (CVIC) Specialty Section, where he is responsible for the training programs related to Data Integrity and Computer Systems Validation; Past Chair for the SQA Education Committee; and Past Chair of the Quality Assurance Consulting Support Specialty Section. Joe is currently a Mentor in the SQA Mentor Program. He is also recognized as a Distinguished Speaker by the SQA Learning Foundation since 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.

Gaurav Kumar

Sr. Compliance Consultant, JAF Consulting

Gaurav Kumar is a seasoned compliance consultant with over a decade of experience
developing innovative solutions for complex technical challenges in implementing software,
equipment, systems, and processes for various clients ranging from universities to big

He specializes in IT Computer System Validation, Equipment Qualification, and Manufacturing
System commissioning and qualification following Quality by Design (QbD), meeting regulatory
expectations, industry standards, and client processes/specifications within clinical and
manufacturing spaces.

Throughout his career, Gaurav has led and managed cross-functional teams delivering high-
quality services, focusing on efficiency and best practices to meet project deadlines and exceed client expectations. His passion for technology/validation/compliance and problem-solving has driven him to stay at the forefront of emerging trends, constantly refining his skills in compliant implementation of cloud computing and the refinement of waterfall and agile methodologies in Computer Systems Validation (CSV) and Computer Software Assurance (CSA).

Gaurav holds a Master’s in Biological Sciences from New Jersey Institute of Technology/ Rutgers University. Connect with Gaurav on LinkedIn to explore his insights into regulatory compliance, quality standards, and validation or to collaborate on innovative validation projects.

Gina Tucker

Sr. Compliance Consultant, JAF Consulting

Gina M. Tucker, MBA, RQAP-GLP is a Senior Compliance Consultant with JAF Consulting, Inc.. Ms. Tucker received her Bachelor of Science from Mount St. Mary’s College and Master of Business Administration degree from Mount St. Mary’s University. She joined JAF Consulting, Inc. in 2022. She has over 17 years’ experience in a global regulated environment, primarily in quality assurance and computer system validation. Ms. Tucker has GLP auditing experience including, but not limited to, toxicology, pathology, method validation, and studies related to the Animal Rule. Ms. Tucker has presented several topics related to computer system validation and GLPs at SQA Annual Meetings.