Regulatory compliance review, continuous

Part 395 continues to be a major regulatory compliance challenge for many motor carriers. Five of the top 12 most cited violations for all compliance reviews conducted in 2006 were hours-of-service related. 

Once again, this importance of an effective management review system that provides continuous, up-to-date, comprehensive, and concise information about the company s overall compliance status is clear in light of the possible regulatory ramifications. In the event that a company has failed to... 

Once in operational use, the validated status of a process control system must be maintained and periodically reviewed to verify continued compliance with regulatory requirements. 

Since 1986, FDA has performed nearly 2100 audits of more than 1400 public (e.g. affiliated with a university, hospital or other institution) and private institutional review boards. Fewer than 20 of these were for cause . Complete compliance was observed for only about 13%i of these inspections and IVo uncovered violations that were serious enough to warrant regulatory or administrative sanctions, which included suspension of clinical studies. The most frequently encountered deficiencies have been inadequate meeting minutes, lack of a quorum at meetings inadequate written procedures, and inadequate continuing review. 

Corporate risk and compliance systems fully reviewed and continue to be improved Regulatory messages sustained Self-regulation fully operational... 

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