Search Results for "root cause"

  1. Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring
    This webinar explains how auditors can investigate unexpected increases in bioburden as part of a bioburden failure analysis that will be used to implement containment, corrections and corrective actions. Every medical device company with a controlled environment and sterilized products is require…
  2. Setting and Validating Bioburden Limits
    Rob Packard of Medical Device Academy provides an example for setting and validating bioburden limits.  Last week, I was in Europe reviewing product specifications with a potential contract manufacturer for a medical device implant. Due to the raw materials that the contract manufacturer currently …
  3. Auditing the Nonconforming Material Process-21 CFR 820.90-Part III
    This blog, “Auditing the Nonconforming Material Process-21 CFR 820.90,” identifies process interactions with the nonconforming material process.  Nonconforming material is not a “bad” thing in and of itself. Having no nonconformities is conspicuous. There are three critica…
  4. Complaint Investigation Case Study (21 CFR 820.198): Part 2
    This article is part 2 of a two-part series specific to complaint investigation requirements as specified in 21 CFR 820.198 (http://bit.ly/21CFR820198) of FDA QSR. This second part explains how to perform a complaint investigation and provides a complaint investigation case study.   Last week’s …
  5. FDA Inspections-Complaint Investigation Requirements-Part I
    “FDA Inspections-Complaint Investigation Requirements-Part I” is a two-part series that provides an overview of 21 CFR 820.198 requirements.  Last week, I received a message from someone asking for advice on how to perform a complaint investigation. She has a complaint handling procedure tha…
  6. 11 Steps to Obtaining CMDCAS Certification-Part 2
    “11 Steps to Obtaining CMDCAS Certification-Part 2” focuses on the process of updating the quality system and preparing for your certification audit. The first three steps focus on classification and selecting a registrar.  Steps 4: Writing a Licensing Procedure Nowhere in the Canadian Medical…
  7. Disposition of Nonconforming Materials-21 CFR 820.90 Compliance
    Disposition of Nonconforming Materials-21 CFR 820.90 Compliance focuses on determining a disposition method, including scrap, return to supplier, rework, use as-is, etc. Part 3 in our series will address process interactions with the non-conforming material process. In our previous blog (http://bi…
  8. 7 Steps to Respond to an FDA 483 Inspection Observation Webinar
    Rob Packard of Medical Device Academy provides 7 proven steps to effectively respond to an FDA 483. Included are examples, recommendations and tips; for implementing the 7 steps including: Respond within 15 business days Use your CAPA form How to document a root cause investigation Don’t forget …
  9. 7 Steps to writing an FDA 483 response
    Responding in 15 business days is one of 7 steps on how to write an FDA 483 response, but do you know what should be in your response?When an FDA investigator has an inspection observation, the investigator issues an FDA 483. “Form 483” is the FDA form number. If your company receives an…
  10. CAPA CONTENT Power Package
    This training information resource package contains 12 content elements which help ensure that your company meets FDA requirements. It includes three webinar recordings, three powerpoint presentations, over 50 pages of exclusive “how to” articles, SOP Template, two checklists, and form: …
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