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If you fail to plan, plan to fail

Posted Jul 30, 2017 in

If you fail to plan, plan to fail
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When the FDA’s 21CFR Part 4 requirements for combination products went into effect, we needed external support to ensure our design history files were clearly established. We contracted Quality Solutions Now, Inc. who was able to quickly provide us with 4 resources that were experts in design control.
Drug/Biologics Manufacturer Quality Fellow