FDA Internal Complaint Handling

Speaker

Instructor: Kelly Thomas
Product ID: 706131
Training Level: Intermediate

Location
  • Duration: 90 Min
Join this webinar to learn approaches to setting up an internal complaint-handling system that ensures compliance with all GMP requirements.
RECORDED TRAINING
Last Recorded Date: Aug-2019

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

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.

Attend to learn the approaches to setting up an internal complaint handling system that is in compliance with all GMP requirements.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to good manufacturing practices.

  • Quality assurance personnel
  • Quality control staff
  • Clinical Operations
  • Regulatory Affairs personnel
Instructor Profile:
Kelly Thomas

Kelly Thomas
Vice President, Americas Quality Operations

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.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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