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Compliance 4 All presents
 Managing Complaints, Small Business Perspective Webinar
The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants, Also learn the approaches to setting up an internal complaint handling system that follows all GMP requirements, from a small business perspective.
Course Description/Agenda
Managing Complaints, Small Business Perspective
Overview:
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.
You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
Why should you Attend:
- The information obtained in this webinar will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.
The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants. Attend to learn the approaches to setting up an internal complaint handling system that follows all GMP requirements, from a small business perspective.
Areas Covered in the Session:
- Review of GMP requirements for complaint handling per 21 CFR 820.198
- Types of complaints that may be received
- Tracking the complaint from time of receipt
- Initiating and performing a complaint investigation
- Review of the complaint and investigation
- Evaluation of complaint per 21 CFR 803
- Preparing a response to the complainant
Who Will Benefit:
- Quality Assurance Personnel
- Quality Control Staff
- Clinical Operations
- Regulatory Affairs Personnel
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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Compliance 4 All
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Course Summary |
The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants, Also learn the approaches to setting up an internal complaint handling system that follows all GMP requirements, from a small business perspective. |
Delivery
Method |
Virtual Classroom (Live) |
Who Should Attend |
• Quality Assurance Personnel
• Quality Control Staff
• Clinical Operations
• Regulatory Affairs Personnel
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Other Information
Virtual Classroom (Live) |
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