Pharmaceutical Data Integrity - Webinar Recording/Transcript

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Pharmaceutical Data Integrity: 5 Steps to Build a Quality Culture

“FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks.”

FDA, Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry

Quality needs to be a top priority for leadership — including building a culture where employees are invested in maintaining quality. 

Cynthia Schnedar, Executive Vice President and Liz Oestreich, Vice President — both of Regulatory Compliance at Greenleaf Health, Inc. — will offer recommendations on how to build and maintain a culture that values quality and supports data integrity in the manufacturing process.  Over the course of 90 minutes you learn:

  • Best practices in building a culture of quality — including compliance with WHO and FDA data integrity standards
  • Why quality must be a top priority for leadership when it comes to maintaining an unadulterated drug supply
  • The nuances in Commissioner Gottlieb’s statement on achieving drug manufacturing quality
  • Tips on how to ensure employees are invested in maintaining quality and how to avoid passive non-involvement
  • How to tie to the importance of quality into a company’s core values
  • The ALCOA principle, which requires that records are attributable, legible, contemporaneous, original, and accurate

You’ll gain practical tips for how to build a quality system and gain insight on WHO and FDA guidance on data integrity.

Compliance personnel who have a role in managing their company’s compliance programs as well as C suite employees should attend:

  • Global Quality & Compliance
  • Regulatory Affairs
  • Quality Systems

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 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. 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. Liz’s legal background includes research and consulting on veterinary medicine, new drug applications, generally recognized as safe (GRAS) determinations, and the regulation of genetically modified organisms (GMOs).