FDA has clearly articulated their position that they are regulators and not industry’s auditors. The Agency’s expectation is that companies employ highly-skilled auditors, capable of conducting meaningful audits that identify any existing compliance issues for management action. Meridan has developed an auditor certification program that includes a combination of classroom training and real-world auditing experience, gained working side-by-side with a Meridan subject matter expert auditor. Your auditors are coached and assessed as they independently conduct audits and draft audit reports. The end result for successful participants is issuance of a certification that documents auditor certification criteria were met.