Conducting An Effective Recall (Managing Internal and External Customers)

This webinar will provide you knowledge to establish a plan for conducting recalls, The knowledge you gain will sharpen your recall management decisions and strategy, And You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.

Swasita Saigal
Instructor:
Swasita Saigal
Date:
Thursday, October 10, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502714

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:

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.

As part of risk assessment, utilization of FDA's health risk criteria (Health Hazard Evaluation) will be discussed so that you can develop incorporate them into our recall procedures. Identification of the root cause of the recall prevents that problem from happening again. We will discuss how to utilize CAPA to prevent the issue to re-occur.

Why should you Attend: Product recalls impact all businesses at one time or another. It is important to establish a good plan and strategy to gain the confidence of your customer and regulatory body that the issue has been identified and a good plan to correct, remove or withdraw has been put in place accordingly.

This webinar will provide you knowledge to establish a plan for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy.

Areas Covered in the Session:

  • Understand FDA's recall authority and policy
  • Learn how to manage recalls under FDA oversight
  • Learn how to interact with FDA
  • See how to develop health risk determinations
  • Learn critical recall strategy component

Who Will Benefit:
  • Post Market Regulatory Affairs Manager
  • Recall Managers
  • Quality Assurance Managers
  • Regulatory Affairs Directors
  • Risk and Product Liability Managers
  • Manufacturer's Sales and Marketing Managers


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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