Description
Maintaining compliance with Good Clinical Practices (GCP) is essential for ensuring the integrity of clinical trials and safeguarding patient safety. This GCP Refresher webinar overviews fundamental principles, recent regulatory updates, and best practices for clinical research professionals. Whether you want to reinforce your understanding of GCP or stay current with evolving industry expectations, this session will provide valuable insights to help you remain compliant and audit-ready.
This free training session is designed for professionals at all experience levels and offers an opportunity to engage with industry experts on critical compliance topics.
Learning Objectives
By the end of this session, attendees will be able to:
โ Reaffirm their knowledge of core Good Clinical Practices (GCP) principles and regulatory requirements.
โ Better understand the interpretations from regulatory authorities such as the FDA and ICH.
โ Identify common compliance challenges and solutions in clinical research.
โ Apply best practices to maintain data integrity and ensure participant safety in clinical trials.
โ Prepare for potential audits and inspections with confidence.
Who Should Attend?
This webinar is ideal for:
โ Clinical research professionals, including CRAs, CRCs, and investigators
โ Quality assurance and compliance personnel
โ Sponsors, CROs, and site management organizations
โ Regulatory affairs specialists
โ Anyone involved in the conduct, monitoring, or oversight of clinical trials
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. Maryโs College and Master of Business Administration degree from Mount St. Maryโs University. She joined JAF Consulting, Inc. in 2022. She has over 17 yearsโ 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.
