E-Learning – E-Learning und Webinare
Webinar: Corrective and Preventive Action (CAPA) and Root Cause Analysis

When it comes to the topic of preventive and corrective actions, the requirements of MDR 2017/745 focus largely on post-market surveillance. However, an effective CAPA process is indispensable for any type of non-conformity in the QM system and flow of goods. It provides substantial benefits, whenever a substantial root cause analysis is required to prevent recurrence. An effective CAPA system includes the assessment of potential serious incidents and any resulting reporting requirements. When determining corrective actions, the risk assessment and any necessary initiation of field safety corrective actions is an essential step for medical device manufacturers. This webinar closes this gap and offers participants approaches to make their CAPA process more effective.

Many manufacturers of medical devices are currently asking themselves:

• What are the specific requirements of the MDR for the CAPA process?
• How is the CAPA process structured and how is it appplied correctly?
• Why is root cause analysis so important?
• Which tools are available for this and how are they applied?
• How do I keep the effort within limits?

Ihr Nutzen

• Practical knowledge of the MDR from the perspective of the Notified Body.
• Sustainable, interactive approach to transfer knowledge.
• Assistance with ambiguities and best practice.
• You will receive a certificate for attending the webinar.
• The webinar consists of coordinated modules and topics.

Teilnehmer

This webinar is addressed to responsible persons and employees of medical device manufacturers from QA/RA, F&E, Service and Support, who are entrusted with the task of installing and maintaining an MDR-compliant CAPA process.

Inhalte

• Relevant regulatory requirement from the MDR
• Requirements for CAPA 
• Implementation in practice

Besondere Hinweise

This webinar series takes place in virtual sessions of 4 hours each. Splitting up in groups, solutions are found in a high level of interaction, conveying the learning content in a sustainable manner.

Technical requirements:

• Google Chrome v31 (or higher) web browser
• A terminal device (PC or Laptop) with audio output
• Windows 10; Mac OS X 10.9 or higher
• A stable internet connection (recommended: at least 1 MB/s)
• GoToTraining Desktop-App (JavaScript enabled) – you will receive the link to download the app a few days prior to begin of the training
• A working microphone (external microphone or headset recommended)
• A Webcam

Ihr Plus

The cooperation of DGQ / DQS MED – both established providers in further education and conformity assessment – combines complementary competences in didactics and contents and imparts sustainable knowledge applicable in daily practice. Competent experts from a Notified Body for medical devices act as speakers.

Up to 2 trainers are also available to answer questions at any time.

The results of the group work with recommendations for action from the perspective of a Notified Body are made available digitally afterwards.

Cooperation

The webinar series around the EU Regulation MDR 2017/745 consists of 15 main topics in total.

All further dates can be found here: https://shop.dgq.de/themen/e-learning

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