It’s no sècret that the U.S. Food and Drug Administration (FDA) has put a huge focus on compliance with good management practices (FDA)—maybe so much focus that drug makers have ignored quality in the rush to stay compliant. Now, FDA has ramped up its scrutiny of brand-name, generic, and over-the-counter drugs— and is calling on the industry to offer up metrics to prioritize fìeld investigations.
Join quality assurance expert Angela Bazigos in this information-packed webinar as she outlines proposed quality metrics—for process, batch, packaging, and distribution quality. Bazigos will discuss the FDA’s draft guidance and reveal the results of FDA and industry discussions to date—including the agèncy’s objective to curb the rise in recalls, drug shortages, and other negative consumer impacts.
Bazigos designed this presentation to offer a true insider’s guìde to the FDA’s new quality focus. Using actual FDA presentation materials as a backdrop, she will present comments obtained directly from the agèncy and industry experts that offer much-needed context and a deeper understanding of this evolving topic.
Cut through the regulatory speak and learn just what’s at stakè for your future compliance efforts, what role the newly established Office of Pharmaceutical Quality will play, and whether you can expect quality metrics to reduce the inspection frequency at your facility. You may already be hard at work improving facilities, modernizing control platforms and process technologies, and rolling out quality-by-design programs at your plant. Unfortunately, the FDA hasn’t seen enough real quality improvement. So get ready for some more scrutiny!
Here is a taste of what you will uncover in this instructive session:
The FDA’s quality metrics
Data guidance for the industry
The agèncy’s request for quality metrics: background, covered drugs and establishments, the quality metrics FDA intends to calculate, optional quality metrics that may be submitted, how FDA intends to use quality metrics, and sections indicated for public comment
FDA public meetings and meeting results
How quality metrics mesh with the Center for Devices and Radiological Health
What the future of pharma reg compliance looks like
CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Read more
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