QA/RA Consulting, Auditing & Training
How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors For a new auditor, the opening meeting is critical. How you conduct yourself, and how organized you are, establishes your credibility and sets the tone for the audit to follow. If you appear unsure and unorganized, your audit will not […]
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The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection Unlike Regulatory Authorities in most other countries, the US Food and Drug Administration (FDA) relies on random inspections to keep medical device manufacturers honest. Random audits can occur at any time, and that means manufacturers must always remain in compliance with the FDA […]
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Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor You├óΓé¼Γäóve heard it many times before: ├óΓé¼┼ôGreat├é┬á(insert any profession here)├é┬áare made, not born.├óΓé¼┬¥ The saying is especially applicable to auditors.├é┬áTruly effective auditors seem to have an ability to effortlessly extract nuggets of good information from their interviewees. They know how to […]
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COVID-19 significantly curtailed FDA’s ability to conduct surveillance inspections of medical device manufacturers. Most manufacturers have not had an FDA inspector show up at their facility since at least March 2020. However, on July 1, 2021, FDA resumed on-site inspection operations, although it remains to be seen how quickly theyll get up to speed. There […]
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Remember FDA inspections’ Yes, we know youve missed them, and chances are extremely high thats because an FDA inspector has not darkened your door since early 2020, likely longer. While virtual meetings are the new normal for many business professionals, its pretty clear that FDA has begun to transition to live, onsite inspections of domestic […]
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FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements? The first paragraph of├é┬á21 CFR Part 11├é┬áseems disarmingly straightforward. It says: ├óΓé¼┼ôThe regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, […]
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