Search Results for "root cause"

  1. 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…
  2. 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 …
  3. 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…
  4. 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…
  5. 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…
  6. 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 …
  7. 7 Steps to Respond to an FDA 483 Inspection Observation
    Responding in 15 days is one of 7 steps on how to respond to an FDA 483 inspection observation. Blog also includes advice from a former FDA investigator.  When an FDA investigator has an inspection observation, the investigator issues an FDA 483. This is the FDA’s form number. If your company rec…
  8. 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: …
  9. How to Prepare for an ISO 13485 Certification Stage 2 Audit-Part 1
    This blog, How to Prepare For an ISO 13485 Certification Stage 2 Audit-Part 1, reviews CAPA records, design controls, and production process controls. Health Canada requires ISO 13485 certification as a requirement for all Medical Device License Applications, and most companies choose ISO 13485 cer…
  10. Success – Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device Inspection
      This 90+minute webinar recording, 21 CFR 820-A Roadmap to FDA Compliance, is a must have “insider’s guide” of tips, examples and advice for specific areas where FDA inspectors will focus their inspection efforts related to the 31 sections of the 21 CFR Part 820 Quality System regula…
Page 3 of 5 12345