Is your Essential Requirements Checklist (ERC) up to snuff?
Instructor:
Cheryl Wagoner
Product ID: 703384
- Duration: 60 Min
Why Should You Attend:
Having an out of date or non-compliant Essential Requirements Checklist (ERC) can prolong review of technical files. It can also result in observations during ISO audits. Keeping your ERC “up to snuff” can help you avoid costly delays in getting to market and may also help you avoid certain audit observations.
This webinar will explain the overall ERC with emphasis on the 6 new requirements.
Areas Covered in the Webinar:
- Background of the ERC and the proposed changes
- Define Essential Requirements and their relationship to Essential Requirements Checklist
- Format of an ERC
- Sections to be addressed in the ERC
- What has changed in the 2012 proposal? How can you meet the new requirements?
- Relationship between ERC, Clinical Evaluation Report, and Technical File
- Resources
Who Will Benefit:
- Regulatory/Quality Managers or Project Managers
- Regulatory/Quality Specialists who Compile European Technical Files
- Clinical Personnel who Contribute to European Technical Files
- Product Development Managers or Project Managers
Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.
Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.
Topic Background:
Annex I of 93/42/EEC: EU Medical Device Directive (MDD) is entitled “Essential Requirements”. Demonstration of compliance with the Essential Requirements is typically done through an Essential Requirements Checklist or ERC. In 2012, the European Commission proposed a new EU Medical Device Regulation that revised the Essential Requirements from 13 to 19 ERs. Notified Bodies place much emphasis on the ERC. It provides them with an overview and pointer document during their review of product technical files.
More Training By Experts
- Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
- Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)
- Creating a Global Regulatory Plan
- How to file a 510(k) when your device is (or contains) software
- Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
