Medical Device Network Group - Sweden: Meeting #3

Quality Processes in a Medical Device Company - CAPAs, Deviations, and Risk Assessment

March 13, 2018
8:15 - 10:30
Stockholm, Sweden
Host: More info soon.


Introduction and Welcome

Share experience and questions about CAPAs, Deviations and Risk Assesment
Moderated by Robert Pettersson, Managing Director, Epista Life Science Sweden

Join this discussion to contribute your ideas and get inspired from other companies – how do they optimize their own processes, interpret regulations and overcome challenges when it comes to CAPAs, deviations and risk assesment? The goal is for participants to go back to their office with new ideas on how to make things more efficient in their own company. Some possible discussion points include:

-        How do you interpret the regulations that govern these processes?
-        How many reviewers and approvers are you inviting for every decision?
-        What is the level of an event that requires a deviation?
-        What are some of the different methods for root cause analysis – pros and cons?

This discussion will be based on participants sharing their experience and asking questions. We expect the meeting to be highly interactive – it is not a ‘lecture’ style of event.

Wrap up and discussion of topic for next meeting

What is the Medical Device Network Group all about?

The group was established for Medical Device peers to network and gain valuable inspiration, insight and operational tips for improving the quality and outcome of their organization’s compliance efforts. This is the group’s third meeting. Whether you joined the first two meetings or want to join for the first time, you as a Medical Device professional in Sweden are welcome. The network group is designed for Medical Device QA, RA and IT professionals, as well as system owners and data owners. Please feel free to pass this invite along to colleagues and peers who are relevant for this specific topic.

We’re looking for a host. Want to volunteer? We need a meeting room for approx. 15 -20 people and some strong coffee – somewhere in or around Stockholm! If you’re interested, send a mail to [email protected].

Note: This is an open invitation for industry practitioners. This event is not open to consultants or vendors.

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