Are You and Your Suppliers Prepared for Notified Bodies 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
• Steps to take in order to meet EU Compliance
• Relationship between Certifications, Product Registrations, and ISO 13485 standard
• The difference between a Notified Body (NB), Certification Body, Conformity Assessment Body and a Registrar
• Frequency of Notified Body 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

Who Will Benefit:

This webinar will provide valuable assistance to all Medical Device Professionals. Employees who will benefit include:

• 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

Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Vanessa Lopez is senior principle quality, and a 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 industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, and Pall LifeSciences among others.

She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of quality assurance, quality control, regulatory compliance, regulatory affairs, quality systems and supplier quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, material, safety and management review boards as well as represented quality in design control phases.

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