Conducting Management Review for Medical Devices; Small Business Perspective

This webinar explores a successful approach to the performance of management review that yields a value-added result and helps gain the buy-in of the executive level whose support is needed from a small business perspective.

Swasita Saigal
Instructor:
Swasita Saigal
Date:
Wednesday, September 11, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502712

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

Management review can be burdensome and difficult if not planned to focus on the right metrics and administered by an efficient process. Management with executive responsibility must review the suitability and effectiveness of the quality system.

This webinar explores a successful approach to the performance of management review that yields a value-added result and helps gain the buy-in of the executive level whose support is needed. from a small business perspective.

Why should you Attend: Under FDA regulations 21 CFR 820.20, Medical device companies are required to perform at least at a minimum an annual review of the quality system. Does your company Communicate and understand the status of your Quality Management System to top Level Management as it is critical? Do you know what information should be provided to FDA? The webinar will address these any other similar topics.

Areas Covered in the Session:

  • Understand the purpose of management review
  • Understand the regulatory requirement for management review
  • Understand an effective process for conducting the review
  • Understand documentation requirements
  • Understand FDA policy regarding disclosure of management review information during inspections

Who Will Benefit:
  • Quality Assurance Managers
  • Manufacturing Managers
  • Regulatory Affairs Managers
  • Senior Level Executives


Speaker Profile
Swasita Saigal is the Director of Regulatory Affairs and Corporate Compliance at Exsurco Medical, Inc., a wholly owned subsidiary of Bettcher Industries located in Wakeman, OH. Swasita brings over 10 years of Medical Device experience, in all aspects of medical device product life cycle management. She is an experienced leader in MDR, Complaint and CAPA remediation projects and third-party audits. She joined Exsurco in 2015. Swasita has been instrumental in building the Quality Management System for Exsurco Medical, Inc. and leading the transition as the company became a Medical Device Manufacturer, registering and listing with the FDA in 2017. The company recently received ISO13485:2016 certification. Swasita developed the Corporate Compliance Program for Exsurco and is an active member of AdvaMed Accel.

She holds a B.A. from John Carroll University, an MBA from the University of Phoenix and is a CQA and an active member of ASQ and RAPS. Swasita is a frequent guest speaker at Regulatory and Compliance conferences across the country. For more information about Exsurco Medical visit www.exsurco.com.




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