by LindaMarie Beitler | Jul 12, 2021 | Uncategorized, White Papers
The Importance of Role Based Training Training is a fundamental part of industry. As a foundational element of what we do, it is important to determine the most effective ways to train in the complex life sciences industry. Boards of Health and other Agencies...
by PathWise | Jun 15, 2021 | Uncategorized
5 Things to Remember When Implementing a Microproject Projects will vary in scope and size, but no matter the task ahead of you, remembering these 5 things will help you as you begin! For more on project management, view the PathWise online training course on...
by PathWise | Mar 24, 2021 | Uncategorized
Why Your Document Control System is Obsolete For many years companies have implemented document control systems that had the ability to manage the version of the document throughout their life cycle. As documents were approved the process would notify users that a new...
by lmb | Mar 2, 2021 | Uncategorized
Data Integrity- A Document Control Challenge The FDA has increasingly observed cGMP violations involving data integrity during inspections. The purpose of the data integrity guidance is to help manufacturers have the tools and systems in place to prevent adulterated...
by PathWise | Feb 10, 2021 | FDA, Uncategorized, White Papers
Inadequate Procedures: A Challenge to the Medical Industry As global populations increase and people are living longer, more strain is being placed on the life science industry. Complex business models have evolved, and new technologies are implemented to support...
by PathWise | Feb 3, 2021 | Uncategorized
FDA 483 Observations from 2020 Every year, PathWise compiles information on the top FDA 483 observations from the previous year’s inspection observations. 2020 was a year like no other, with the Coronavirus halting FDA inspections for a time. The results for the...
