Training Procedure: "Mistakes to avoid and audit advice" [ISO 13485]

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Training Procedure: "Mistakes to avoid and audit advice" [ISO 13485]

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Күн бұрын

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.
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► 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.
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► 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.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized 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, Podcast, Online courses...
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► Links from the Video
■ Rod LinkedIn: www.linkedin.c...
■ Katie Linkedin: www.linkedin.c...
■ Meddev Solutions Website: www.meddevsolutions.co.uk
■ Trinzo Website: www.trinzo.com
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #compliance

Пікірлер: 8

@rajpaljagtap03 2 жыл бұрын

Nice discussion!!!

@EasyMedicalDevice 2 жыл бұрын

Much appreciated

@erickawhite7271 Жыл бұрын

And what about a webinar? Can be catalogued like a way to update à knowledge or competence?

@EasyMedicalDevice Жыл бұрын

I suppose if you are getting official proof of your attendance and maybe also the material that was presented, this may be something to include in your curriculum. But that alone will be difficult to justify that you have all the necessary knowledge. It is like proving you have looked at a KZfaq Video. This may not be recognized by all Notified Bodies.

@alpadodhiya3176 2 жыл бұрын

Much needed podcast, thank you Monir !!

@EasyMedicalDevice 2 жыл бұрын

Thanks for your message. Appreciated

@sigujo 2 жыл бұрын

Appreciate this podcast, informative and constructive. Regarding the effectiveness assessment on procedures (timestamp 19:00), you would effectively need to have two assessment for each? One for initial training and another for employees already trained in previous version.

@EasyMedicalDevice 2 жыл бұрын

Thanks for your feedback. For your point, this depends on the rules you define. If the change of version is minimal you can define that no formal assessment is needed. But really depends on each companies and cases