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The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.
High profile drug recalls, food chain problems and contamination, import problems, resignations.Â Now a new commissioner vows no more "business as usual".Â Data in submissions and decisions rendered will be more science-based and subjected to greater scrutiny.Â Failure to comply will result in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control.Â Yet it often is a companyâ€™s weakest link in compliance. Why so?Â FDA expectations?Â How are successful companies meeting this challenge. Tools that need to be put in place or enhanced.Â Getting personnel buy-in. Getting senior management buy-in. Supplier buy-in.
Areas Covered in the Session: