This webinar is being offered free to all attendees.
Registration is now open. RSVP and join the cohort via the link below:
About the Program:
REDCap has established itself as a vital tool in creating and managing 21 CFR (including but not limited to parts 11, 50, and 56), GDPR, HIPAA, compliant electronic informed consent, and electronic data capture components in the clinical trial management system.
The Computer Software Assurance (CSA) concept within the context of the FDA (Food and Drug Administration) refers to a risk-based software implementation methodology ensuring the safety, efficacy, and quality of software used in the FDA-regulated industry.
Implementing the REDCap system utilizing the CSA provides a robust cost, time, and labor-effective methodology to implement computer systems in the FDA-regulated industry.
Learning Objectives:
This webinar shall provide tools and resources to identify validation requirements to implement FDA-compliant REDCap to conduct eIC and EDC processes supporting the clinical trial management system.
Who Should Attend?
This webinar is suited for all technical and non-technical resources (IRB support staff, System Owners, Technical Owners, Management, Quality Assurance, and Validation team) involved in the REDCap operations and administration from a beginner level to an advanced level in familiarity with computer systems validation.
Meet Your Hosts:
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
pharmaceuticals.
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.