Pharmaceutical Data Integrity - Webinar Recording/Transcript
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.