The decision to file a section 15(B) report with CPSC is often a difficult decision, resulting in and complicated by many other regulatory and legal implications such as the need to hire experts and conduct health and other technical or engineering analyses, contractual and commercial issues affected by a government notice, and potential follow-on commercial and product liability lawsuits.
Hear an experienced consultant and lawyers who routinely advise consumer product companies discuss the multifactorial decisions and work streams that should occur as your company considers and decides to file a section 15(b) report, including when and how to hire a consultant, how to create and assess data inputs on which to base a decision, what a US report means for your ex-US notification requirements, potential obligations under government, commercial supply and licensing contracts, how to manage possible whistle-blower complaints, and how to prepare for and mitigate potential follow-on litigation resulting from recalls and other corrective actions.
FDA partner Kathy Sanzo will lead a panel on Consumer Product Complaints and Section 15(b) Compliance: Legal and Regulatory Considerations and Implications as part of the ICPHSO 2015 Meeting and Training Symposium on February 25.
February 23–26, 2015
Hyatt Regency Grand Cypress
1 Grand Cypress Boulevard
Orlando, FL 32836