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Karen Drahos-Peifer


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1 to 4 of 4 total

“CAPA”/Improvement Process: Understanding the Past to Prepare for the Future

Posted By Karen Drahos-Peifer 02/07/25 07:37 AM
Found In Community: Minnesota Section Events
Since 1996 with the publishing of both the US FDA 21 CFR 820 Quality System regulation and ISO 13485:1996, the requirements for Corrective and Preventive Action (CAPA) came into being for the medical device industry. Over time, the concept of corrective action and preventive action has been incorrectly ...

“CAPA”/Improvement Process: Understanding the Past to Prepare for the Future

Posted By Karen Drahos-Peifer 02/07/25 07:32 AM
Found In Community: Medical Device Division Events
Since 1996 with the publishing of both the US FDA 21 CFR 820 Quality System regulation and ISO 13485:1996, the requirements for Corrective and Preventive Action (CAPA) came into being for the medical device industry. Over time, the concept of corrective action and preventive action has been incorrectly ...

Revisions to ISO 9000 & 9001 Are Coming. Why are these changes important?

Posted By Karen Drahos-Peifer 01/14/25 06:43 PM
Found In Community: Minnesota Section Events
ISO 9000 is the foundation of the Quality Management System Standards and changes are coming. It looks like the updates to ISO 9000 will be published ahead of 9001. Mark is on both working groups. Mark will dive deeper into and explain the Fundamental Concepts and Principles ...

Revisions to ISO 9000 & 9001 Are Coming. Why are these changes important?

Posted By Karen Drahos-Peifer 01/14/25 06:35 PM
Found In Community: Medical Device Division Events
ISO 9000 is the foundation of the Quality Management System Standards , and changes are coming. It looks like the updates to ISO 9000 will be published ahead of 9001. Mark is on both working groups. Mark will dive deeper into and explain the Fundamental Concepts and Principles of Section ...