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Description
In the realm of computerized systems validation (CSV), periodic review stands as a crucial process for maintaining compliance, identifying improvements, and optimizing system performance. However, executing an effective CSV periodic review requires a deep understanding of regulatory requirements, risk management principles, and industry best practices.
This one-hour webinar offers a comprehensive exploration of CSV periodic review, guiding participants through the essential elements of the process and providing actionable insights to enhance its efficacy. Through a combination of theoretical frameworks, practical case studies, and interactive discussions, participants will gain a thorough understanding of the nuances involved in conducting successful CSV periodic reviews.
Learning Objectives
Key topics to be covered include:
→ Understanding Regulatory Expectations: Navigating the regulatory landscape governing CSV periodic review, including guidelines from regulatory bodies such as the FDA, EMA, and ICH.
→ Establishing a Risk-Based Approach: Implementing a risk-based methodology to prioritize systems for periodic review, assess criticality, and allocate resources effectively.
→ Developing Comprehensive Review Protocols: Designing robust review protocols encompassing system documentation, configuration changes, user access controls, and data integrity considerations.
→ Leveraging Data Analytics and Automation: Harnessing the power of data analytics and automation tools to streamline periodic review processes, identify trends, and uncover potential issues proactively.
→ Addressing Findings and Implementing Corrective Actions: Developing strategies for addressing findings identified during the periodic review process, implementing corrective actions, and documenting outcomes.
Led by seasoned CSV experts and industry practitioners, this webinar provides a platform for knowledge sharing, peer collaboration, and professional development in the field of CSV periodic review. Participants will emerge equipped with practical tools, methodologies, and best practices to navigate the complexities of periodic review, drive continuous improvement, and ensure sustained compliance with regulatory requirements.
Join us for this informative session to gain valuable insights, exchange experiences, and elevate your CSV periodic review practices to new heights of excellence.
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) and periodic review 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.
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.
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.