ComplianceOnline

Are You and Your Suppliers Prepared for Notified Bodies Unannounced Audits?

Instructor: Vanessa Lopez
Product ID: 705136
  • Duration: 120 Min
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Read Frequently Asked Questions

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
  • 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
Instructor Profile:
Vanessa Lopez

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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FDA's Medical Device Software Regulation Strategy
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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