FALLS CHURCH, Va., March 18, 2019 /PRNewswire-PRWeb/ -- Pharmaceutical Data Integrity 5 Steps to Build a Quality Culture **An FDAnews Webinar** Tuesday, April 2, 2019, 1:30 p.m. - 3:00 p.m. EDT
http://www.fdanews.com/pharmadataintegrity
Are controls in place to ensure that data is complete? Are activities documented at the time of performance? Are activities attributable to a specific individual? Can only authorized individuals make changes to records?
The FDA recently posed these questions, among others, in their new pharma CGMP guidance.
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, attendees will learn:
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).
Who Will Benefit: Compliance personnel who have a role in managing their company's compliance programs as well as C-suite employees should attend:
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/pharmadataintegrity By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
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Are controls in place to ensure that data is complete? Are activities documented at the time of performance? Are activities attributable to a specific individual? Can only authorized individuals make changes to records?
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The FDA recently posed these questions, among others, in their new pharma CGMP guidance.
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, attendees will 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
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).
Who Will Benefit: 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
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/pharmadataintegrity By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
