The FACT Quality Boot Camp was just held on Monday 19 February 2024 with Process Validation as the major theme of the day. We spent the whole day listening to brief but in-depth presentations by experts, with lively question and answer sessions and then my favorite - the activity that complements the presentations. The activity digs into the presentation with a new topic (in this case we focused on Infusion of Cellular Therapy Products) and discusses what we need to do to wrestle that Validation Plan into shape.
We start off the day laying the foundation for you by establishing what we mean when we say Validation, Verification and Qualification. We want everyone to be speaking the same language and having the same understanding. We are all starting from the same place and slowly building on that foundation. Piece by piece we want to pull together the parts of the Validation Plan in a way that makes sense, then get our results, organize and summarize them, then provide a conclusion and hopefully approve the whole validation. I want to encourage everyone to think of the Validation Package as being documentation for their future self and therefore we need to provide enough context that we’ll be able to interpret it in three, five, or seven years’ time. We want you to leave with the ability to create your own plan. And even though it’s a long meeting on paper, the day flew by.
Shout out to Table 10 and the great discussions and camaraderie that we had!
Check out the next Quality Boot Camp scheduled for Wednesday, 1 May 2024 at the Victoria Conference Centre in Victoria BC. This is a joint venture with FACT and CTTC (Cell Therapy Transplant Canada)
Remember that you’ll get a Certificate of Attendance and this will count towards your CEs for the year, especially if you are a Quality Manager or in a Quality role. You’ll also have access to all of the meeting materials before and after the Quality Boot Camp, plus the presenters and facilitators are always happy to answer any lingering questions. If you need help justifying your attendance at the Boot Camp, check out my Conference Travel Justification Bundle for assistance in organizing your request and budgeting your travel costs.
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