PRODUCT COMPLAINTS AND ADVERSE EVENTS

Improving Risk-Based Decision Making Effectiveness:
Insights From Other Industries

ABSTRACT

Product complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This article provides an overview of the receipt, investigation and categorization of product complaints. An example of a product complaint triggered by a serious adverse event is also described. Please note that the example serious adverse event and product complaint is described in a high-level manner to protect confidentiality of the patient, hospital and company involved.

Kimberly Wallbank

Principal Consultant, Quality Systems Services, LLC


Kimberly Wallbank is a Quality Systems and Regulatory Consultant with more than 25 years in industry. She has diverse experience and expertise in assisting pharmaceutical, biotechnology and medical device companies achieve compliance with FDA, EMEA, ISO and other recognized standards. She has worked with many pharmaceutical and medical companies in assessing, updating and implementing their complaint handling programs. Kimberly has a BS from Marquette University and MBA from University of Phoenix. She currently resides/works out of New Rochelle, New York.

Nicole Damour.

Temple RAQA Ph.D. Candidate

Nicole works as a regulatory CMC professional and has significant experience in drug product and process development and technical writing. She also has experience as an FDA Reviewer. She is completing her Ph.D. at Temple University in the School of Pharmacy Regulatory Affairs and Quality Assurance Program.