WEBINAR - Complaint Handling: An Insider’s View of Effective Management Practice

Instructor: Eldon Henson Director, Quality for Pharmaceuticals and Research and Development

Covidien (formerly Mallinckrodt)

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➢PowerPoint Presentation (PDF)

➢Webinar recording

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Webinar Content

• Definition of a product complaint

• Benefits of a solid complaint handling program

• GMP requirements for complaint handling systems including written procedures, systems to capture complaints, quality unit responsibilities, assessment for serious and adverse drug experiences, comprehensive investigations, extension of the investigation, CAPA systems to ensure correction and prevention, close-out documentation, and trend monitoring

• Document requirements for complaints

• Current FDA expectations, inspection trends, and example citations

• Practical aspects of managing the complaint system during FDA inspections

• Questions and Answers

What Attendees Will Learn in This Webinar

In this webinar, you will review or learn the following:

➢Basic elements of a solid complaint handling system

➢Benefits of managing complaints effectively

➢Practical aspects of preparing your program for an FDA inspection

➢Effectively managing the complaint review during inspections

➢At the end of this program, you should have the necessary tools to assess potential gaps in your own complaint handling system.

Questions and Answers

There will be a 15 minute question and answer period for attendees to submit questions on their systems. If weare unable to answer your question due to time constraints, our instructor Eldon Henson will provide a response after the webinar concludes.

Who Should Attend

This webinar is an ideal presentation for those individuals in your organization involved in the following functions:

➢Managing the complaint system

➢Conducting investigations

➢Assembling and assessing complaint data, management for those groups

➢Quality assurance

➢Quality control

➢Quality systems

➢Quality engineering

➢Production

➢Research & Development

➢Management involved in any aspect of complaint management

About Your Instructor:

Eldon Henson has been in the pharmaceuticalindustry for over 25 years at a variety of firms representing solid dosage forms, aseptically processed products, liquids, medical nutritionals, biopharmaceuticals, API’s and foods. His experience is primarily in the areas of quality assurance and compliance, though he has considerable experience in manufacturing, quality control and R&D at companies, such as Novartis, Abbott, Boehringer-Ingelheim, Sigma-Aldrich, and others. During his time in this industry, he has over 3000 hrs of direct contact with FDA investigations, most of which included coverage of complaints and complaint handling systems.

➢This recording is now part of a CONTENT package. Read more...