FDA Internal Complaint Handling

  • Kelly Thomas
  • 23, August 2019 Friday
  • 10:00 AM PDT | 01:00 PM EDT (90 Min)

Join this webinar to learn approaches to setting up an internal complaint-handling system that ensures compliance with all GMP requirements.

Live Online Training
August 23, Friday 10:00 AM PDT | 01:00 PM EDT (90 Min)

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training
Last Recorded Date: Aug-2019

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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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:
Peggy Berry Peggy Berry

Founder, Synergy Consulting LLC

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

Refund Policy

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. FDATrainingAlert 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 customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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