I share your interest in hearing stories of recent encounters with the FDA. I can tell you that a major OEM was here this week to help qualify (audit) us to build a more complex device, in a higher FDA Class, then the components we've been supplying them for years...
I give them credit... they were thorough, and seemed to agree amongst themselves of what it takes to get these process validations and equipment qualifications up to where they should be...
I gave Elsmar Cove credit during a post-audit debrief meeting we had yesterday; none of their observations were new to me, and really what I heard from them was consistent with the consensus opinions which develop over some of the threads here...
A "comprehensive plan" is very important; it should be through and specifically include processses which are planned for verification as opposed to validation, as well as present a program of formal monitoring and re-validation...
Statistical rationale is a hot topic as well, for sample sizing, as well as confidence levels of any conclusions drawn through capability studies... you've got to be covered as to justifying your inputs as well as justifying conclusions drawn from your outputs...
Following admonitions to include considerations of risk in designing these verifications & validations, a relatively simple approach of using the highest severity seemed to be received well... also, I really tried to follow the process validation guidance document (GHTF) closely point-to-point to ensure protocols were planned well enough... this was seemingly sufficient...
The question I came away with is: having never met FDA, are they typically expected to be exacting above and beyond the requirements of a big Customer? I feel like we got a pretty good workout this week, and hopefully we'll be in good shape in case FDA ever does drop in!