Speaker Profile


Swasita Saigal

Director, of Regulatory Affairs and Corporate Compliance at Exsurco Medical, Inc.,

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.

  •  Wednesday, September 11, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • $150.00
Conducting Management Review for Medical Devices; Small Business Perspective

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.

  •  Thursday, October 10, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • $150.00
Conducting An Effective Recall (Managing Internal and External Customers)

The webinar will cover what it takes in conducting an effective recall. You will learn practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.

  •  Tuesday, October 22, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • $150.00
Managing Complaints, Small Business Perspective

This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.

View All



  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
Conducting Management Review for Medical Devices; Small Business Perspective

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.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
Conducting An Effective Recall (Managing Internal and External Customers)

The webinar will cover what it takes in conducting an effective recall. You will learn practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
Managing Complaints, Small Business Perspective

This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $390.00
Conducting Management Review for Medical Devices; Small Business Perspective

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.

View All

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