“The Silver Sheet” is the medical device industry’s premier guide to manufacturing quality system compliance issues. We deliver the most reliable and insightful news and analysis of the FDA’s interpretation and enforcement of the Quality System Regulation, based on our extensive contacts with officials and staff within FDA and quality systems managers throughout the industry.
“The Silver Sheet” helps executives in regulatory affairs and quality control, plus industry attorneys and consultants, improve compliance, reduce costs, understand trends in recalls and warning letters, adopt new best practices and avoid disastrous inspection results.
“The Silver Sheet” offers in-depth, monthly coverage that includes:
- Analysis of developments in FDA compliance policies and enforcement actions
- Trends in FDA inspections
- Best practices in quality control
- Device recall and warning letter data
- Early warning of new directions in FDA enforcement policy
- Insights from peers on maintaining a spotless quality system
- The latest in international harmonization practices
- Interviews with sources deep within FDA’s device compliance organization
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