During what is usually a 2-3 day in-person audit, I will evaluate your facility’s  compliance (with 21 CFR Part 111 and other applicable FDA regulations) and assess your manufacturing, quality, and laboratory systems. I  can also audit contract manufacturers for cGMP compliance, qualify your vendors, and check out your third party contract laboratories.

I am available to do remote (desk) audits of documents at short notice without a site visit, this includes FDA-required records such as: specifications, master manufacturing records, batch records and SOPs.  Please contact me for more details of this service.