Search Results for "root cause"

  1. 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…
  2. 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…
  3. 7 Considerations for Outsourcing Medical Device Complaints
      Investigating medical device complaints can be a time-consuming task. This blog reviews seven considerations for outsourcing medical device complaints. Two different clients of mine recently mentioned that they are overwhelmed by the amount of time required to investigate complaints and to file …
  4. Webinars for Sale & YouTube Channel
    In addition to the webinars available for purchase on this page, you can also watch videos that we have posted on our YouTube channel (please remember to Like & Subscribe). Now that we have 1,000+ YouTube subscribers, we will be live streaming videos on our YouTube channel. If you subscribe to …
  5. 7 Steps to Writing a CAPA Procedure Compliant with ISO 13485:2016
    Your cart is empty This article lists seven steps to writing a more effective CAPA procedure, ensuring that your procedure is risk-based and training people effectively. During a recent internal audit, I was performing for a new client, and I noticed that they were not meeting one of the requireme…
  6. Implementing Design Controls – 10 Steps
    The article explains ten steps of implementing design controls, including design plans, design inputs, design review, verification protocols, and risk management. FDA Guidance for Implementing Design Controls The diagram above is called the “Application of Design Controls to Waterfall Design Proc…
  7. Effective Management Solutions for 10 CAPA Program Blunders
    The author provides effective management solutions for ten real-life CAPA program blunders., (i.e., procedures, root cause analysis, closing CAPAs, etc.) Effective Management Solutions for 10 CAPA Program Blunders I am always looking for new and creative ways to help people understand the importan…
  8. How to Utilize CAPA Training To Avoid FDA 483 Citations
    The author discusses how formal CAPA training can help solve the four most common CAPA deficiencies and help avoid FDA 483 citations. Corrective And Preventive Action (CAPA) is considered to be one of the most critical processes in a Quality Management System (QMS). CAPAs prevent nonconformities fr…
  9. Keeping Design Projects on Schedule: Using the CAPA Process
    The author provides two steps to consider taking now and steps to take in the future that will help keep design projects on schedule using the CAPA process. The ability to get new, high-quality products to market quickly is the most important core competency for a company to develop. What is your c…
  10. How to perform a quantitative CAPA effectiveness check
    This article review explains how to conduct a quantitative CAPA effectiveness check, and you will also learn three methods NOT recommended. There are three methods NOT recommended for a CAPA effectiveness check: verifying the procedure was revised, verifying employees were retrained, and making su…
Page 4 of 6 «...23456