FDA Internal Complaint Handling

Duration: 90 Minutes
The information obtained 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.
FDA Internal Complaint Handling
Instructor: Kelly Thomas
Product ID: 505045
Objectives of the Presentation
  • Review of GMP requirements for complaint handling
  • 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
  • Preparing a response to the complainant
  • Preparation of an associated SOP
Why Should you Attend
FDA expects all employees at a company to receive basic training on how to recognize complaints and what actions to take. Attend this training to learn the approaches to setting up an internal complaint handling system that is in compliance with all GMP requirements.

Who will Benefit
  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing Personnel
  • Quality Assurance and Clinical Operations Personnel
  • Regulatory Affairs
  • Marketing
  • Medical Affairs
  • Legal
  • Regulatory Compliance
$299
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $379.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $429.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
View More