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2-hr Virtual Seminar: Are You and Your Suppliers Prepared for Notified Bodies Unannounced Audits?

Duration : 2 Hours

Vanessa Lopez,

Vanessa Lopez is senior principle quality,  regulatory and compliance consultant. She has held a wide variety of leadership roles in the medical device (Class: I, II, and III), pharmaceutical (API; finished product) and environmental regulated industries as well as the consulting services ind Read more

To provide a clear understanding on impact the EU Commission Recommendation has had on tighter controls, roles and further responsibilities of Notified Bodies and other changes, which will impact manufacturers and their corresponding suppliers. As a result, this webinar furnishes details on how can these latter parties prepare for a Notified Body routine surveillance and unannounced audits. Advance preparation and planning to these changes and others, will help you have a smoother transition to what is expected and required. This webinar will also provide the challenges and benefits of successful results from Notified Body routine and unannounced audits.

Why Should You Attend:

This is a detailed webinar designed to provide medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced Notified Body (NB) audits. The webinar will provide attendees with the major changes in CE certification as it relates to unannounced audits and other associated topics, as a result of EU Commission Recommendation 2013/473/EU.
It also explains the impact this recommendation has on manufacturers, NBs, subcontractors, suppliers and service providers. Furthermore, it provides background information on NBs purpose and CE marking. It will walk you through, the rationale, strategies and flow on how to plan for an audit (announced and unannounced), the audit process and approach, and which company roles should be assigned for Notified Body audits, including each of their responsibilities.

Areas Covered in the Webinar:

The following topics will be addressed during this webinar:

• Purpose of Notified Bodies Audits
• Key Definitions
• MDR Transition Strategies
• Some Changes to the Directives (MDD/AIMD/IVD) Which are Now Part of  the Regulations(MDR/IVDR)
• High Level Medical Device Steps to EU Compliance
• Relationship Between Certifications, Product Registrations, and ISO 13485 standard
• The difference between a Notified Body, Certification Body, Conformity Assessment Body and a Registrar
• Frequency of Notified Body (NB) Audits and Where to Find Most Current List of EU NBs
• Changes and Adverse Events, Who to Notify
• Major Changes in Medical Device CE Certification Related to Unannounced Audits and Other Matters
• Preparation for a Notified Body Audit
• Audit Process: What to Expect from Notified Body’s Arrival Up to Their Exit
• Timelines to Respond to Notified Body’s Audit Reports and Sequence to Follow in Your Response
• Challenges
• Conclusions
• References

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Auditors
• Compliance Officers
• Executive Management
• Managers (Regulatory Compliance and Regulatory Affairs)
• Manufacturing Directors and Supervisors
• Personnel new to the Medical Device Industry
• Suppliers/Subcontractors/Service Providers
• QA/QC Personnel
• Document Control Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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