Philadelphia Chapter Webcast: Medical Device Single Audit Program

1.5
RAC Credits
Chapter Events
Thursday, 29 July 2021 (12:00 PM) - Thursday, 29 July 2021 (1:30 PM) Eastern Time (US & Canada)

Member: $10
Nonmember: $25

Learn audit approaches and principles with the globalized Medical Device Single Audit Program (MDSAP) directly from EU Notified Body, GMED North America. In this session, GMED Compliance Director, Florianne Torset-Bonfillou, will discuss questions with MDSAP lead auditor Cathy Kraeer in an interview format presentation.

Learning objectives will include:

  • Major differences between ISO/QSR and MDSAP audits
  • Audit of applicable regulations within the MDSAP audit
  • High grading NCs situations and specific process
  • Common pitfalls observed during MDSAP audits

A live Q&A portion with the speakers will follow the presentation.

Learning Level: Intermediate (with Basic reminders)

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

This event is brought to you by the RAPS Philadelphia Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credits.

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation. 

 

Featured Speaker:

Florianne Torset-Bonfillou, RAC, director of compliance, GMED North America

Cathy Kraeer,  MDSAP lead auditor, GMED North America


Thank you to our Platinum Chapter Sponsors:



Event Policies

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

Registration fees for this event are nonrefundable. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org