QSG Quarterly Meetings are a forum for learning and interactive discussion about topics related to current industry trends. At each meeting we feature a presentation by an industry expert and invite attendees to share their experiences and best practices with the group. Quarterly Meeting attendees appreciate the ability to develop new relationships through QSG’s unparalleled peer network and bring fresh new value added ideas back to their organizations.
Quarterly Meetings are held on-site at Member locations.
December 7, 2018 (12–3, includes lunch)
Location: Tegra Medical LLC
8 Ledgewood Blvd, North Dartmouth, MA 02747
What is a Process Validation?
The collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product.
Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the industry.
How many lots/units should I make?
Are we taking enough samples?
Do we need to use statistics in our protocols?
The real question may be: am I even focusing on the right questions?
More than IQ, OQ, and PQ – a solid validation system includes master validation planning, effective protocol writing, and change communication.
FDA’s 21 CFR 820 and ISO 13485 require process validation, but they don’t offer much guidance. During this meeting, we will hear about the Process Validation at Tegra Medical LLC. We will walk through a simple process through the entire validation cycle – writing protocols, determining key operating parameters, and identifying data analysis strategies and the execution of the complete process
Join us for to discuss this very important tool for process analysis/improvement.
12:00 – 2:45 – Lunch
12:45 – 2:30 – Presentation (Process Validation at Tegra Medical LLC)
2:30 – 3:00 – Questions