Data Integrity
Latest Regulatory Developments and Best Practices

Tuesday, Jan. 14, 2020 • 1:30 p.m. - 3:00 p.m. EST

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 a webinar Jan. 14 so you ensure compliance with the FDA.

Webinar Takeaways:

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. Join us by registering today.

Who Will Benefit

Pharmaceutical manufacturers
Consultants
Suppliers
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

Webinar plus USB Audio Recording/Transcript Learn more Best Value! You’ll have access to one log-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an USB audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.	$487
Webinar only Learn more You get one log-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.	$287
24/7 Encore plus USB Audio Recording/Transcript Learn more You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials, plus an USB audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.	$487
24/7 Encore Presentation Learn more You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials.	$287
USB Audio Recording/Transcript Learn more You'll receive an USB audio recording and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is approximately two weeks after the session.	$287

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.

Data Integrity Latest Regulatory Developments and Best Practices

Tuesday, Jan. 14, 2020 • 1:30 p.m. - 3:00 p.m. EST

Data Integrity
Latest Regulatory Developments and Best Practices