ComplianceOnline

Building a Winning MDR Team and Process

Instructor: Kwame Ulmer
Product ID: 705634
  • Duration: 60 Min
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This webinar will teach you the key elements on how to build a winning MDR team and its process. This webinar will discuss the best practices in complaint handling, screening & evaluation for reportability, employee training and expectations which helps the medical device manufacturers in building an effective MDR Reporting and stay abreast of regulatory changes and lead key personnel to stay current in training and compliance.

Why Should You Attend:

MDR Reporting is a critical element of any Medical Device Manufacturers Quality Management System. It requires employee engagement, understanding of applicable Code of Federal Regulations and understanding of the interplay between complaint handling.

Attendees will learn the key elements of a winning reporting system and how they relate to other functions (ex: Complaint handling management, Screening & Evaluation for reportability, employee training and expectations). The presentation will cover best practices for reporting and building a winning complaint handling and MDR team.

Areas Covered in the Webinar:

  • Best Practices in Complaint handling
    1. Understanding team roles
    2. Understanding the relevant regulations
    3. Understanding the process
  • Best Practices in Screening & Evaluation for reportability
    1. Using templates to screen signals
    2. Installing Best-In-Class procedures
    3. Installing a winning escalation process
  • Employee training and expectations
    1. Best practices for training
    2. Training approaches to avoid
    3. Incentive's for training

Who Will Benefit:

  • Quality Assurance
  • Regulatory Affairs
  • Sales Personnel
  • Compliance Professionals
Instructor Profile:
Kwame Ulmer

Kwame Ulmer
Medical Device Executive, Angel Investor

Kwame Ulmer is a MedTech executive with 15 years of experience in government and the private sector. Mr. Ulmer integrates his experience working as an operating company executive, evaluating over 1,000 technologies at FDA, advising early stage companies, and formal business education to deliver high-impact consulting services.

Mr. Ulmer previously served as Vice President, Regulatory Affairs & Quality Assurance at Implant Direct, a Danaher Corporation Operating Company. Mr. Ulmer, led all efforts to accelerate market access via shortened global registrations timelines, improved product quality via process optimization and led activities resulting in best-in-class department engagement scores.

Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA). He managed the two fold growth of a Division to 74 employees and has personally evaluated hundreds of cardiovascular, ophthalmic and dental technology applications.

Topic Background:

Since 2011 FDA has required individual malfunction reports for devices, unless a reporting exemption or variance was granted for specific devices, or until the agency gave further notice on summary reporting criteria.

FDA launched a pilot initiative to explore criteria for quarterly summary reporting for low-risk Class I and Class II devices. Manufacturers must stay abreast of regulatory changes and lead key personnel to stay current in training and compliance.

Regulations: FDA 21 CFR 820.198 , ISO 13485:2016 section 8.2.2.

Follow us :
Managing Your Complaints and Obstacles in Post-Market Requirements
Vendor and Supplier Qualification Program for FDA Regulated Industries

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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