Oct 16 2024 47 mins 10
in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team.
Who is Georg Digel?
I've reviewed too many Medical Device CAPAs over the last 10 years. I think I've seen almost every mistake there is ...Some of my "favorites":
- Initiating CAPA without gathering facts
- Setting up KPIs but not monitoring them
- Confusing Correction with Corrective Action
To be honest - I've made many of these mistakes myself.
Luckily, I learned and improved. Over time, I even took on bigger responsibilities. Some projects which I really enjoyed:
- Process harmonizations for 60 sites
- Setup of training programs for 1.000+ people
- KPI dashboard implementations for 813 CAPAs
My learnings were paired with painful experiences. I want to save you from all of them. My goal is to help you:
1. Avoid CAPA related audit findings or 483s
2. Implement meaningful metrics for your CAPAs
3. Train your people so they close records effectively
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link
Georg Digel LinkedIn: https://www.linkedin.com/in/georgdigel/
Vincent Cafiso Podcast episode: Are you More Corrections or Corrective Actions or Preventive actions? https://www.youtube.com/watch?v=YsXfBv_AdWc
How to be the best at CAPAs with Karandeep Badwal: https://www.youtube.com/watch?v=zWK1U7d2awY
Most important issues on CAPAs: https://www.youtube.com/watch?v=lR4r14V5oHA
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
