April 2006 Post Dinner Presentaion
Minimizing the Fear Factor in FDA Inspections Gale E. Van Buskirk
Gale E. Van Buskirk, the President of RegTech Ltd presented at the MNASQ April 2006 meeting. The goal of the presentation was, as stated in the title " Minimizing the Fear Factor in FDA inspections". The subject matter was presented in a professional, and entertaining manner. One might gather that fact when she compared preparing for an inspection to preparing for the visit of ones Mother-In-Law !
The main areas covered were:
- Questions to ask before the FDA arrives; such as: Who will be the primary contact in your firm?, Do you have a company policy regarding cameras and other recording devices?.
- Writing your SOP with external inspections in mind, and the two types of inspections: announced, and un-announced.
- Do and Don't actions during inspections, such as Do know the law, and Do Not leave the inspector alone ( even in the restroom !!), and Do Not argue with the inspector !!!