The New EU Medical Devices Regulations Training
This 2 half-day simulated compliance seminar will take care of the basics and that may help you to getting into the particulars of the European Union Medical Device Regulation (EU MDR). It provides case studies and share lessons learned so your group can advantage from the faults of others. We will review the latest changes to the regulations effective and in force and will draw out important growths and key dates. The looming EU MDR crisis: It also protect your patients in the end too.
Controlling affairs managers are presently absorbed on establishing and handling the concluding steps of the change to bring into line corporate policies with new necessities and procedures. This session will focus on the time remaining in the transition period and what companies can suppose from informed bodies and managers as the application deadline draws to a close, as well as descriptive parts of indecision such as applying acts and important adequate scientific proof.
The new EU Medical Devices Regulations (the MDR and IVDR) for medical devices and 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are fully prepared the leadership papers and applying lawmaking to guarantee the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. Nevertheless, there is still much to do, and progress has been slow.
Complete Agenda for Day 1 & Day 2
An outline of the EU-MDR, concentrating precisely on crucial changes
How to measure your changeover program to include the whole operation
How to conduct a detailed gap examination precise to EU-MDR transition
How to plan and scope your EU-MDR change program
Deliberate approaches for tendency reports
Converse Post-Market Investigation plans and what data should be included in the Technical Papers
The important steps of applying an EU-MDR changeover program
Assessment appropriate indicators for benefit-risk analysis
Review new EU-MDR Requirements impacting Post Market Surveillance:
Discuss methods and protocols to communicate effectively with Competent Authorities (CAs), Notified Bodies, users
Discuss Post-market Clinical Follow-up (PMCF) plan
Periodic Safety Update Report (PSUR)
Discuss active and systematic approaches to collection and assessing data
Discuss effective tools to trace and identify devices for which corrective actions are necessary
Review how to proper investigate complaints
Objectives of the Course:
At the end of EU Medical Device Regulation Training, the trainees would be able to do the following:
Clarify the new controlling prospects concerning Risk Management
Comprehend how to smear those requirements
Appreciate the consequences of non-compliance
Understand the controlling requirements EU-MDR and the impact on Post Market Surveillance
Who are the beneficiaries of EU Medical Device Regulation Training Course?
Risk Management, and Post-market activities
R&D specialists for Development
Suppliers and other medicinal device professionals in areas of Design
Industrial and Marketing Managers
Internal and External Auditors, Importers
Medical Device Manufacturers and Professionals within Senior Management
Regulatory Affairs Managers and Quality Managers
Faculty Kelly Thomas
Vice President, Americas Quality Operations
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.