How to Organize and Conduct Product Complaint Investigations

Why Should You Attend:

Every firm that manufactures FDA regulated products sold to consumers will at some time receive product complaints. What can happen when product complaints are ignored? How the firm responds to and handles the complaints is incredibly important both to the good will of the firm in the marketplace and to how FDA perceives the firm.

Do you have in place a written plan that encompasses a thorough investigation in order to find the cause of the problem and possible solution? Do you have SOPs on how to handle bad publicity by getting the firm out in front of bad news with its own news? Do you have a pre-organized crisis management plan to keep the product complaint from becoming viral on the Internet? What procedures do you have that take into account the results of an investigation in making decisions about a product’s labeling, contents, method of processing, even packaging and distribution?

This webinar will provide the necessary information to those in food, drug, device, cosmetic and related industries that manufacture and distribute products to consumers on how to best receive, respond, investigate and correct product complaints in the best interests of the firm.

Areas Covered in the Seminar:

• How to design a plan for responding to, handling, resolving and closing a product complaint.
• Using the CAPA plan with a product complaint.
• How to recognize a bogus product complaint from a real complaint.
• Building a product complaint team in a company.
• The education and training of a competent product complaint investigator.
• Ten rules to follow in the investigation of a product complaint.
• When to report a product complaint to the government.
• When to talk to your competition about common product complaints
• Making sure the complaint is fully investigated and knowing when to stop.
• Protecting the interests of the firm while dealing with consumers who have made product complaints.
• Making the decision to recall a product based upon a product complaint.
• Assessing the risk in making decisions about a product complaint.
• Keeping your plan for resolution of product complaints up to date.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Quality Control/Quality Affairs
• Regulatory Affairs
• Product Development
• Engineers/chemists/biologists
• Operations/Production

Instructor Profile:

Charles R. (Bob) McConachie is a Dallas, Tx attorney. He has practiced food and drug law beginning in 1970 at the Department of Justice where he litigated FDA enforcement and regulatory law cases in federal courts. From 1975 to 1979 he served as Chief of the Consumer Affairs Section, now the Consumer Protection Division of the Civil Division at DOJ. Among other cases he personally argued the case in which the FDA’s decision to remove Red Dye No. 2 from the market by the end of the day was upheld by the DC Circuit.

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