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Our facility (contract manufacturing) has been registered with the FDA not too long ago. We want to prepare well for a possible FDA audit, but our team is relatively inexperienced and only has little experience with ISO 13485 audits. Our notified body for ISO audits has offered us to perform a 3-day mock audit for conformity to FDA 21 CFR part 820 requirements.
Does anyone have experience with mock audits by external experts? Is this an effective way of preparing for a real FDA audit? Are there any alternative ways to get the support of external parties in preparing an FDA audit?
Does anyone have experience with mock audits by external experts? Is this an effective way of preparing for a real FDA audit? Are there any alternative ways to get the support of external parties in preparing an FDA audit?