Welcome to the 27th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today on the podcast, Mandy is bringing you a topic that has yet to be discussed in-depth on the show, and that is Laboratory Investigation Reports (also known as LIRs) and critical elements to consider when designing or implementing enhancements to the quality management process. Ensuring that your LIR process is robust is critical to your business operation and will help set you up for success if scrutinized during an inspection. All-in-all, it is a key part of the QMS.
Joining Mandy today is Life Sciences veteran and Quality expert, Kathy Landes, to provide expert feedback on this topic! Kathryn has more than 20 years of experience and is an absolute wealth of knowledge in this space! As someone who has spent many years developing and managing QC laboratories as part of her career as a quality professional and knows the LIR process inside and out, Kathy sheds light on some of the key areas to consider, breaks down some of the processes to their fundamental parts, and highlights many important considerations related to LIR.
Key Takeaways:
[:30] About today’s episode.
[1:22] Mandy welcomes Kathryn Landes to the podcast!
[1:57] Kathryn gives an overview of her background in the Life Sciences space.
[4:10] What is the intent of the LIR process? And what are the key elements that must be included as part of a robust process?
[8:13] What are some common issues or barriers related to the LIR process that are often scrutinized by regulatory agencies?
[14:27] Kathryn recommends some best practices for companies that are new to implementing this process as part of their QMS infrastructure as well as those who are focused on improving their existing process.
[19:22] What steps should be taken when the root cause of an issue cannot be pinpointed through the LIR process?
[23:50] Mandy recaps the key learnings from today’s podcast and thanks Kathryn for her time!
Mentioned in this Episode:
