Tune Up Your CAPA System: A Practical Guide
, the management report that will take you through the latest trends in FDA CAPA enforcement, highlight the deficiencies that inspectors are finding and offer you insight into where you should look to determine the effectiveness of your CAPA systems.
Place your order today and get:
- The most common CAPA deficiencies cited by FDA
- Advice for auditing your CAPA program
- An overview of key problematic CAPA requirements
- Guidance for ensuring adequate investigations
This management report includes an expert analysis of real-life warning letters and a step-by-step guide to what the FDA looks for when it inspects your CAPA system. Plus, you’ll get a list of best practices to make sure your system can stand up to the agency’s scrutiny. Also included is an appendix that contains the full text of the FDA’s own Compliance Program Guidance Manual and Guide to Inspections of Quality Systems.
Tune Up Your CAPA System: A Practical Guide is a must for anyone responsible for keeping their medical device or pharmaceutical company from getting cited by the FDA in a warning letter or Form 483, including:
- Compliance officers
- Consultants and service providers
- Executive management
- General/corporate counsel
- Manufacturing directors and supervisors
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- Regulatory and legislative affairs professionals
- Risk management specialists
- Strategic planning and business development staff
- Study personnel
Tune Up Your CAPA System: A Practical Guide will help you find and fix problems before the FDA sees them. It’s just $337 and available to you today in print or PDF format.
Interested in purchasing more than one print copy?
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copies of the same book. You must order them at the same time and
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3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%
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