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After 20 years in Clinical Quality Assurance I was actually starting to doubt myself. A few days ago I was requested to provide a proposal for a systems audit of a service provider, but we only had one day in which to do the audit! I explained to the potential...read more
As contract auditors, the one area that we are frequently asked to reduce time for in proposals is preparation. I often wonder whether the client company realises what a false economy this actually is. Unfortunately, this is usually a decision made by the finance or...read more
Part 2 When the inspection is in progress, keep the inspection team addressed of any issues or problems as they arise. If there are known issues with trials, explain the issue and the resolution taken to address that issue. Explain and express the reasons for any...read more
Part 1 Firstly, it is important to understand that inspections should not be considered as either “successful” or “unsuccessful”. They take place based on the relevant legislative requirements, and findings that arise are a result of inadequacies in the quality...read more
Welcome to the brand new Adamas Consulting CQA blog on the brand new website. With the launch of the new site, we’ll be launching few new features; a blog where we’ll be talking about the latest news and events from Pharmaceutical & Biotech industry;...read more