Issue #45 of SmarterCompliance is now available. Content includes:
- Challenges in retaining electronic data for FDA compliance
- Cost-effective GCP auditing (part two)
- Recent FDA 483 citations on certificates of analysis
- Trend watch
- Leadership quick-tips: Prioritizing projects
- Book of the month: Making It All Work
Subscribers have access to newly published documents including:
- OIG report on how FDA-CMS collaboration can reduce drug and device costs
- FDA final guidance for lens manufacturers and distributors
- FDA-CMS collaboration notice from the Federal Register
- EMA guidance on clinical trial data retention and transfer
If you'd like to get an FDA newsletter like SmarterCompliance (ISSN: 1937-0776), along with hundreds of bonus downloads, templates, checklists, and regulatory agency advice, you may subscribe online by following this link. Members of SQA, RAPS, FDLI, and AMDM can receive a significant discount.
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Posted by: air max | 18 October 2010 at 04:45 AM