Training Process – What are the mistakes to avoid? [ISO 13485]
The training process can create a lot of non-conformances during audits and this is why we will try to explain to you how to avoid that. Rod and Katie from Trinzo will be helping us to create a compliant training process. We will talk about internal training and also training organized by external companies. We will discuss the way an auditor can find some of the issues. The effectiveness monitoring will also be important to cover. So don’t miss this episode of the podcast.
Who is Rod Beuzeval?
Rod is a regulatory expert with 24 years’ experience in regulated pharmaceutical and medical device companies and holds a RAPS RAC Global scope certification. Rod develops and routinely delivers training on EU MDR,EU IVDR, MDSAP, ISO 13485, risk management, clinical evaluation and provides consultancy on projects within this realm. Throughout Rods career, he has worked with many medical device and IVD companies, helping them to achieve and maintain compliance. With both industry and notified body experience Rod is able to understand what exactly is needed and how to implement it in an effective manner.
Who is Katie Cooney?
Katie is the Training Centre of Excellence Lead at Trinzo She has over 15 years of experience in a variety of training roles and has performed these roles across all levels of the business. Her experience has been gained within Multinational Manufacturing including Medical Device, Pharmaceuticals and Automotive.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
Links from the Video
- Rod LinkedIn: https://www.linkedin.com/in/rod-beuzeval-rac-00452317/?originalSubdomain=uk
- Katie Linkedin: https://www.linkedin.com/in/katie-cooney-08ab7061/?originalSubdomain=ie
- Meddev Solutions Website: www.meddevsolutions.co.uk
- Trinzo Website: www.trinzo.com