by pathwise123 | Aug 19, 2024 | Uncategorized
Role-Based Training in Investigations and CAPA In the highly regulated environments of medical device and pharmaceutical manufacturing, ensuring quality and compliance is paramount. Effective investigations and Corrective and Preventive Actions (CAPA) are critical to...
by pathwise123 | Jun 12, 2024 | FDA, Investigations/CAPA, Uncategorized
What’s the Right Number of CAPAs? Spoiler alert- it’s not an exact number, and that number isn’t zero. The right number of CAPAs will vary organization to organization based on several factors, which we will outline for you below to take into consideration when...
by LindaMarie Beitler | Mar 29, 2023 | Uncategorized, White Papers
Key Performance Indicators for Life Science The number of possible KPIs is endless. It all depends on what is important to that entity. The KPIs mentioned here all have one thing in common; besides the fact that they are important to their businesses. They are all...
by LindaMarie Beitler | Feb 1, 2023 | Uncategorized
Top FDA 483 Warning Letter Observations from 2019 for Medical Device, Drugs, and Biologics Every year, PathWise complies information of the top FDA 483 inspection observations. View trends, and see what common struggles are industry wide. See what all the hot topics...
by LindaMarie Beitler | Dec 21, 2022 | Uncategorized
FREE WEBINARS! PathWise has offered FREE webinars throughout the year. For the next three weeks, enjoy ALL the webinars again! Titles include: When Root Cause Eludes You Human Error is Not a Root Cause How to Qualify Lead Investigators 7 Habits of Highly IN-Effective...
by LindaMarie Beitler | Oct 19, 2022 | Uncategorized
21 CFR 820 and ISO 13485:2016 Harmonization: Getting Ready for the QMSR The purpose of this document is to provide recommendations for the transition of 21 CFR 820 to harmonization with ISO 13485:2016. This document is intended for current users of 21 CFR 820, those...
