Validation Best Practices: Considerations
The following is an edited excerpt taken from The Windshire Group’s webcast Validation: Tried and True Success Lessons from the Front Lines Expert Panel Discussion-LIVE FREE…
Conducting Proper Deviation Investigations: Critical Elements
The following is an excerpt taken from The Windshire Group’s webcast “Conducting Proper Deviation Investigations Expert Panel Discussion – Live FREE Webcast”. Daniel DeLucy: Deviation investigations are a…
Change Control: General Points to Consider
The following is an excerpt taken from The Windshire Group's webcast "Implementing a Change Control Quality System Successfully Expert Panel Discussion - Live FREE Webcast"…
Cell Therapy Process Manufacturing and Quality
The following is an excerpt taken from The Windshire Group’s webcast “Cell Therapy Expert Panel Discussion”: Dr. James Blackwell: It will not be business as usual. Sloppy…
Is there a requirement what needs to be included the batch record?
The following answer to the question “Is there a requirement what needs to be included the batch record? I am asking from a standpoint, if…
What if I have a component that is a critical piece of the process, but there is only one supplier that can provide it, and they recently failed their supplier audit?
The following answer to the question “What if I have a component that is a critical piece of the process, but there is only one…
What are the areas of greatest risk for data integrity issues?
The following answer to the question "What are the areas of greatest risk for data integrity issues?" is taken from The Windshire Group’s webcast “GMP Data…
Building a Quality Culture: Management Understanding QMS “State of the Union”
Building a quality culture for a firm is often a challenging task. Sustaining it can often prove to be even more challenging for upper management…
Computer System Validation- How Early in Product Development?
We are sometimes asked how early in development companies need to start worrying about computer system validation? While predicate rules do not directly answer this…
Critical Considerations in the Design, Fabrication, and Integration of a Clean-in-Place System
This discussion features the design, fabrication and integration of Clean-In-Place (CIP) systems. CIP is used in the food, beverage, biotech and pharmaceutical industries. CIP is…