This session by Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss serious product quality problems – dealing with the press and the public based on actual cases.
Medical product problems may arise from various cases and situations (e.g., device design, product use errors, manufacturing, labeling, device failures, adulteration, counterfeit, packaging, mix-ups, defective components, contamination, therapeutic inequivalence, or therapeutic failure, etc.).
When there is a concern about any medical product’s safety, performance, or quality (drugs, biologic, dietary supplements, cosmetic or devices), any person may/should report to the US Food and Drug Administration (FDA) or any regulatory agency of the jurisdiction that the event falls under so that these data can be used to maintain product safety surveillance of these medical products. The FDA, on its own initiatives, may conduct risk-based inspections.
FDA notifies the firm in the form of a Warning Letter when the Agency finds that a firm has significantly violated Good Manufacturing Practice (cGMP) regulations.The Warning Letter identifies the firm’s violations including, but not limited to, poor and inadequate manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the firm to inform FDA of its plans for correction.Sometimes, depending upon the severity of the quality problems, FDA may enter into a legal agreement (“Consent Decree”) with a firm. In a recent consent decree, FDA states “firms that fall short of our requirements risk FDA action to stop distribution of their products.”
The FDA’s Warning Letters and Consent Decree gets publicized to the public. As a result, firms may experience serious consequences financially, including negative publicity and an import ban of medical products to the US from foreign countries.
This session will provide great opportunities to become familiar with the regulatory requirements, non-compliance, causes, consequences and solutions including how to deal with the press and the public with increased awareness and beyond.
The speaker will also share his PASS-IT recommendation/suggestions.
Areas To Be Covered in this Session:
Get answers to your questions in a Q&A segment after the session by the speaker.
Who should attend:
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.