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Internal audits can not only help you spot current problems, they can also help you correct them now and prevent them in the future.
That’s what Auditing to Ensure Manufacturing Quality: Predicting and Preventing Problems will do for you.
Internal audits can point to problems that must be corrected immediately. But when done right, they can empower you to get ahead of problems. You’ll uncover trends that predict future issues you can correct now. And you’ll improve efficiency and ensure compliance with quality management rules and standards.
This report covers the different types of audits and inspections and explains how to use them to improve quality.
It also describes how a quality culture benefits your operations (efficiency, reliability, sustainable compliance and fewer manufacturing problems, to name a few ways!).
And it explains how to build a quality culture into your organization using concrete examples and strategies you can tailor for yourself, including how to turn data into actionable knowledge.
Management Report Takeaways:
- How to use a risk-based approach to audits, including following regulatory requirements
- Taking a proactive approach to quality audits rather than a reactive one
- The importance of identifying, quantifying and creating a quality culture
- Steps to take when a quality issue is identified through the audit process
- The best practices for documenting and tracking resolutions to identified issues
- How to effectively implement long-term quality risk management changes based on audit observations
- How audit data can be used proactively to drive continuous process improvement
- How you can link audit observations from different sources to create a complete picture of operations and identify and allocate resources
Stop approaching internal audits solely as a way to find and fix random, isolated issues; use them as an opportunity for system-wide transformation. Auditing to Ensure Manufacturing Quality: Predicting and Preventing Problems will show you how.
About the Contributors
Susan Schniepp is a distinguished fellow at Regulatory Compliance Associates (RCA). She is the knowledge leader responsible for training and advising RCA staff and clients on current trends and issues facing the pharmaceutical, biotechnology and medical device industries.
Steven Lynn is the executive vice president of pharmaceuticals for RCA. He has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. Prior to joining RCA, Lynn was the director of the Office of Manufacturing and Product Quality in the FDA’s Center for Drug Evaluation and Research (CDER).
Seyed Khorashahi is executive vice president of medical devices and chief technology officer for RCA. He has more than 25 years of experience leading research and development teams in all aspects of creating safety-critical medical devices. Khorashahi has held leadership positions at Covidien (Medtronic), Baxter and Beckman Coulter.
Michael de la Torre is the founder and CEO of Redica Systems, a data and analytics platform that helps life sciences companies stay compliant with changing regulations and enforcement. He previously served as the chief research officer for LeisureLink, was a VP/GM at Sungard Availability Services and started his career at McKinsey.
Tiffany Anderson is the senior manager of global quality compliance at Nelson Laboratories, where she works with electronic quality management system improvements, regulatory audits and compliance assessments, and integration/harmonization for the global organization.
Who Will Benefit
- Quality assurance personnel (all levels)
- Operations personnel (all levels)
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Contributors:
Susan Schniepp, Steven Lynn, Seyed Khorashahi, Michael de la Torre and Tiffany Anderson
ISBN-13:
978-1-60430-207-3
Publication date:
March 2023
Page count:
97
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