Product Details
The International Council for Harmonisation’s (ICH) Q10 guidance on pharmaceutical quality systems has been an essential resource for quality professionals since its adoption by the FDA in 2009. Yet many drugmakers still struggle to implement the kind of integrated quality system it envisions.
ICH Q10 Pharmaceutical Quality System — Unpacked and Refreshed, a management report from FDAnews, a WCG Company, provides an expert walkthrough of the Q10 guidance, detailing how to look beyond the silos that so easily develop around drug-making activities. The report is based off content provided in one of our most popular FDAnews’ webinars. It was presented by Tim Fischer, managing partner with Great Solutions, who has worked in life science compliance for more than 30 years.
Report Takeaways:
- Understand ICH Q10’s indispensable guidance for pharmaceutical quality systems.
- Grasp design considerations for creating effective quality systems.
- Integrate quality system initiatives with business operations.
- Hone your quality system for continuous improvement.
- Use your control strategy to help manage the product lifecycle.
If your goal is to create an effective quality system that won’t just check off boxes to satisfy the regulators, the advice and instruction found in ICH Q10 Pharmaceutical Quality System — Unpacked and Refreshed is the resource you need. It will ensure continuous improvement across the lifecycle of your products, and, ultimately, will align your quality activities with your business operations.
About the Contributor
Tim Fischer, managing partner, Great Solutions, has worked in life science compliance for more than 30 years, beginning with Abbott Labs in Chicago, where he gained experience in lab operations, manufacturing and technical support. He has also worked for a number of contract manufacturing organizations, as well as with popular compliance software platforms. In his current practice, he focuses on quality software initiatives, GMP auditing and FDA/supplier remediation.
Who Will Benefit
- Drug manufacturers
- Contract manufacturers
- API manufacturers
- Quality managers
- Regulatory and compliance personnel
- Senior-level executives
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Contributor:
Tim Fischer
ISBN:
978-1-60430-229-5
Publication date:
April 2024
Page count:
192
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