The United States Food & Drug Administration (FDA) continues to intensify their compliance oversight with increased Quality System Surveillance Inspections and Warning Letters being sent to Healthcare companies. Warning Letters are issued only for violations of regulatory significance. The good news is that the FDA publishes Warning Letters on their web site as a public service. The FDA web site provides certain search filter capability to help review Warning Letters for a particular industry. In this webinar we will review the best calibration related FDA Warning Letters generated over the past few years. We will analyze the warning letters and discuss best practices that would avoid these compliance violations. With this knowledge, we can learn from these violations and ensure that our calibration programs do not negatively impact the cost of quality for our organizations. Hosted by: Perry Johnson Laboratory Accreditation, Inc. Presented by: Walter Nowocin
Measurement Uncertainty and Decision Rules with Dr. Susan Audino
Common Findings in Assessments to the ISO/IEC 17025:2017 Standard in 2023
Adding DOECAP-AP Accreditation to a DoD ELAP Accredited Laboratory
A Look at ISO/IEC 17025:2017 - Section 6.6 - Externally Provided Products and Services
Understanding the PJLA Flexible Scope Policy for Testing Labs, RMPS, and PTPs
A Look at ISO/IEC 17025:2017 - Overview of the Requirements Specified for Equipment in Section 6.4
Measurements Gone Wrong Webinar with PJLA & Henry Zumbrun
A Look at ISO/IEC 17025:2017 - Requirements for Corrective Action
An Overview of 17043 Proficiency Testing Provider Accreditation with PJLA
A Review of the Revised PJLA Policy PL-4 “Scopes of Accreditation”
Understanding the Types of Reference Materials, Their Differences, and Their Uses
I Submitted a Complaint - Why is this Organization Still Accredited?
Use of Accreditation Symbols and References to Accreditation
A look at ISO/IEC 17025:2017 - Section 7.2 “Selection, Verification, and Validation of Methods”
A Look at ISO/IEC 17025:2017 - Review of Section 8.5 “Actions to Address Risks and Opportunities”
A Look at ISO/IEC 17025:2017 - Section 7.6 “Evaluation of Measurement Uncertainty” for Testing Labs
Common Findings in Assessments to the ISO/IEC 17025:2017 Standard in 2022
Requirements for Internal Audits in ISO/IEC 17025:2017
Streamlining Laboratory Efficiency with Greg Cenker
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