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About the Program:
This hour-long refresher webinar aims to provide participants with a comprehensive overview of Good Laboratory Practices (GLP) as described in 21 CFR Part 58 and incorporate insights from the FDA Bioresearch Monitoring (BIMO) inspections conducted up to the 4th Quarter 2023. The webinar will serve as a valuable resource for individuals working in the pharmaceutical, biotechnology, and medical device industries who need to ensure compliance with GLP regulations and stay updated with FDA inspection trends.
The webinar will discuss the fundamental GLP principles and their significance in ensuring the reliability and integrity of nonclinical laboratory studies. This will include an exploration of regulatory observations described in FDA Warning Letters and historical observations from US regulatory inspections up to the 4th Quarter 2023. In addition, the webinar will discuss practical strategies and tools for maintaining and enhancing effective quality systems within a facility.
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 GLP regulations
→ Be aware of the common pitfalls and challenges faced by organizations
→ Understand practical strategies for maintaining and enhancing compliance
Who Should Attend?
This webinar will benefit quality assurance and operations professionals that facilitate and participate in regulatory inspections including those responsible for the maintenance of an effective quality management system. Personnel include but are not limited to QA, laboratory management, facility management, and testing facility management.
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.
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.