Data Integrity – Webinar Recording/Transcript
Data Integrity: Latest Regulatory Developments and Best Practices
Data integrity issues can break clinical trials, delay approvals of product applications and cost sponsors time, money and credibility.
How much do you know about the latest regulatory developments and best practices?
The FDA consistently communicates the importance of supporting data integrity. You need to know when you’re required to report significant data integrity issues discovered pre-submission and the advantages of early disclosure to the FDA — even when no early disclosure obligation exists.
Join FDAnews and CenterWatch for this presentation so you ensure compliance with the FDA.
The presentation will cover:
- An overview of the FDA’s expectations for data integrity, including the statutory and regulatory basis for those expectations
- Key guidances governing data integrity concepts in both the GMP and GCP context –such as the Data Integrity and Compliance with GCMP Guidance for Industry in the GMP context and the E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) in the GCP context
- The FDA’s recent regulatory actions addressing data integrity issues, including warning letters, import alerts and injunctions
- Best practices to use in responding to questions FDA raises concerning data integrity – such as ensuring a systemic response to deficiencies and using independent third-party auditors
- The quality by design principles to follow in order to ensure quality and avoid data integrity issues, including identifying key resources – such as the Q10 Pharmaceutical Quality System Guidance for Industry and the Clinical Trials Transformation Initiative (CITTI) Quality by Design Principles Document and Toolkit
Learn why data integrity is so important and the significance the FDA places on quality.
Meet Your Presenters:
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc.
Cynthia has more than 25 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government. Cynthia was formerly Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues.
Elizabeth (“Liz”) Oestreich, Vice President, Regulatory Compliance, Greenleaf Health, Inc.
Liz brings a diverse background of legal, public policy, and non-profit sector knowledge to her position as Vice President of Regulatory Compliance. Prior to joining Greenleaf Health, Liz served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC. While at FDLI, she gained extensive experience in all FDA-regulated product areas. Liz’s role included regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs.
Who Will Benefit?
- Pharmaceutical manufacturers
- Heads of compliance, or anyone on a compliance team
- Executives who oversee quality programs
- Others working in areas related to the production of FDA-regulated drug products and the process by which companies manage and implement the quality systems within those manufacturing processes