Investigations

05
May

Ready for an FDA Inspection? Be prepared. Read our Contract Pharma article.

Being proactive is always better than being reactive. And when it comes to a possible “visit” from FDA, anticipation and preparation go a long way in lowering anxiety and navigating the process successfully. Knock, knock. When an FDA investigator walks into your facility informing that they are going to conduct an inspection, a tense moment […]

Read More
03
May

Are You Initiating Quality Investigations When Required?

When a firm is evaluating the effectiveness of their investigation program (as part of assessing the effectiveness of the Quality Management System (QMS)) the focus tends to be towards evaluating the quality / robustness of the resulting investigations. However, one of the questions that should also be asked is are investigations being initiated when required? […]

Read More