Please allow me a moment of your time. My name is Sarah Christie and I am a Doctoral Candidate at Florida Tech that is gathering data about a topic that I believe will help all of us in the Quality field. I am trying to see if certain types of quality management practices have an impact on non-conformances. I hope to see if there is a connection between certain quality management practices and FDA 483 observations. The survey will take approximately 10 minutes to answer. I plan on sharing the results with everyone once I compile the data!
Please note that no one's name or company's name will be shared. This information will be coded to ensure confidentiality. I truly thank everyone for their time and effort. I need to obtain quite a few more survey results and appreciate everyone's help.
Here is the link:
I answered the survey, but based on some of your survey questions and I am curious what directions your literature survey has taken you. Let me know if you want to discuss how some GMP pharma organizations are handling this (such as PDA and ISPE) and how it aligns (and doesn't align) with the ASQ's approach(es)
Thanks Trish! I will post it today!
Thanks Jeremiah! There really isn't a lot of information from an academic side when it comes to GMP pharma / FDA readiness / data integrity. One of the reasons why I am so interested in this topic is that as a quality practitioner myself I thought this would be a great way to bride that gap. I would love to chat about how we can bring academia into the 21st century when it comes to quality!
are you just looking for companies that have FDA related products?
Hey my father in law went to Fla Tech!
I answered the survey but I feel like I may have over-scoped myself. I work in a small group at a big company. BIG company. I started answering for the whole company but then some answers really were geared towards my group or team. It might have been helpful to have an up front clarification like “if you work at a large corporation, answer for your building or site or other subdivision that you have direct familiarity with”
Thank you James! I appreciate your help. I was trying to get an overall understanding of how organizations look at quality management topics. I definitely will take your thoughts into consideration for my next topic!
Thank you to everyone who has responded. I am so close to having enough data points. Just a few more and I can start analyzing the data. Thanks again!!