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.
NEXT MEETING – “Lessons Learned” from FDA Warning Letters
When: March 20, 2020 (11:30 – 2:30, includes lunch)
Location: SMC Ltd., 18 Independence Dr, Devens, MA
In this meeting, we will discuss lessons learned from numerous FDA inspections and will review in detail several warning letters. We will discuss how regulatory action is escalated from routine or directed inspections to FDA 483 observations to Warning Letters and the impact of Warning Letters on the business for product approval submissions, design change submission and expansion.
We will also discuss the process for responding to the FDA 483 observations and subsequent Warning Letter (if issued). Lessons learned from these experiences will be shared at each stage.
Here’s one Lesson Learned: When you commit an action to FDA follow through and meet your commitments!
Join us as we discuss this very important topic.
11:30 – Check-in (please check-in at the front lobby, sign an NDA and you will be escorted to the meeting room)
12:00 – 12:30 – Lunch
12:30 – 3:00 Presentation & Discussion
QSG Members -Contact firstname.lastname@example.org to Register!