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Data integrity is the bedrock of credibility, reliability, and compliance in today's data-driven landscape, spanning industries from healthcare to finance. As organizations increasingly rely on data to inform critical decisions and drive innovation, ensuring the integrity of this data becomes paramount. However, maintaining data integrity presents multifaceted challenges, ranging from technological complexities to human error and regulatory scrutiny.

This one-hour webinar provides a comprehensive exploration of strategies and best practices to safeguard data integrity across diverse organizational contexts. It delves into the core principles of data integrity, emphasizing accuracy, completeness, consistency, and security as foundational pillars. Through real-world case studies and industry insights, participants will gain a nuanced understanding of the challenges and opportunities inherent in data integrity management.

Learning Objectives

Key topics covered include:

→ Understanding the Regulatory Landscape: Navigating the regulatory requirements and compliance standards governing data integrity, including FDA's ALCOA principles and GDPR guidelines.

→ Implementing Robust Data Governance Frameworks: Establishing comprehensive data governance frameworks to enforce accountability, transparency, and control throughout the data lifecycle.

→ Leveraging Technology Solutions: Exploring innovative technologies and tools designed to enhance data integrity, including blockchain, encryption protocols, and automated validation processes.

→ Mitigating Risks and Addressing Vulnerabilities: Identifying common risks and vulnerabilities associated with data integrity lapses, and implementing proactive strategies to mitigate these threats.

→ Cultivating a Culture of Data Integrity: Fostering a culture of accountability, ethical behavior, and continuous improvement to uphold data integrity standards across the organization.

Led by industry experts and thought leaders, this webinar offers practical insights and actionable recommendations to empower participants in their journey towards maintaining data integrity excellence. Participants will walk away with a robust toolkit of strategies and best practices to fortify their data integrity initiatives, enhance organizational resilience, and foster stakeholder trust in an increasingly data-centric world.

Who Should Attend?

This webinar will benefit Quality Assurance (QA), Operations, and Information Technology (IT) professionals who 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 Your Hosts:

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.

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.