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
A Look at ISO/IEC 17025:2017 - Section 8.9 Management Review Requirements and Utilization
A Look at ISO/IEC 17025 - Section(s) 6.3 & 6.4
Option A and B as Presented in ISO/IEC 17025:2017 along with the Management System Documentation 8.2
A Look at ISO/IEC 17025:2017 - Section 7.9 “Complaints”
ISO/IEC 17025 Section 7.6 - Evaluation of Measurement Uncertainty
Common Findings Detected on Environmental Lab Assessments
A Look at ISO/IEC 17025:2017 - Section 7.7 & Associated Requirements Within PL-1
Improve Your Force Measurements: Tips to Improve Your Force Measurements
A Look at ISO/IEC 17025:2017 - Section 7.8 “Reporting of Results”
The Metals in Cannabis Method with first action status by AOAC & The Road to Get There…
A Look at ISO/IEC 17025:2017 - Section 7.1 “Review of Requests, Tenders, and Contracts”
Common Findings in PJLA Assessments to the ISO/IEC 17025:2017 Standard in 2021
A Look at ISO/IEC 17025:2017 - Section 5.0 “Structural Requirements”
Testing for Gluten and Allergens: Why We Do It and How To Do It Well
A Look at ISO/IEC 17025:2017 - Section 6.6: Externally Provided Products and Services
ASCA Biocompatibility and Basic Safety and Essential Performance FDA Pilot Program with PJLA
ISO 17034:2016 General Requirements for the Competence of Reference Material Producers
A Look at ISO/IEC 17025 2017 - Section 7.10 - Nonconforming Work Section 8.6 - Improvement
5 Steps to the Accreditation Process with Tracy Szerszen
A Look at the Requirements Specified in PJLA Policy on Measurement Uncertainty PL 3
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