Manufacturers need to be able to respond immediately to the possibility of a serious adverse event.
Bloomington, Minnesota (PRWEB) September 07, 2011
A webinar designed to help manufacturers understand and prepare for the ramifications of the new Canada Consumer Product Safety Act (CCPSA) will be presented at 12:00 p.m. CDT on September 14, 2011, by SafetyCall International, an industry leader in adverse event management and post-market surveillance services for industry.
The webinar, “How the Canadian Consumer Product Safety Act WILL Affect Your Business,” will explore the wide reaching impact of the CCPSA as it relates to manufacturer responsibilities for mandatory adverse event reporting, and how it impacts both Canadian and U.S. reported adverse events. “The goal is to help manufacturers understand what they need to do to comply with the Act and adjust to this ever-changing regulatory environment,” said Rick Kingston, PharmD, President, Regulatory and Scientific Affairs at SafetyCall International. Kingston and regulatory specialist, Ryan Seaverson, also from SafetyCall, will lead the webinar.
Following completion of the webinar, participants will have an understanding of the broad scope of this new regulation, including what consumer products are subject to reporting and what products are excluded. Participants will gain knowledge about the criteria that makes an incident reportable under CCPSA, and how adverse incident reports should be evaluated for medical severity and causality.
The webinar will be particularly beneficial to regulatory affairs specialists, risk managers, safety officers, public relation officers, customer service staff, scientific affairs groups and legal staff.
The CCPSA went into effect in June, changing the way adverse events are reported in Canada, and putting greater responsibility on manufacturers and retailers to notify the Canadian government about product safety issues.
The legislation applies to both products that are manufactured in Canada and those imported from other countries. Industry experts predict regulatory uncertainty and unnecessary litigation for manufacturers who are not well-informed about the new legislation and ready to deal with its consequences.
“Manufacturers need to be able to respond immediately to the possibility of a serious adverse event,” said Kingston. “They need to have a mitigation plan in place. This webinar is designed to help manufacturers understand that they must have a plan of action in place before they need it.”
Ultimately, the webinar will help participants provide guidance to their organization on how potentially reportable adverse incident reports should be tracked and assessed to ensure compliance with CCPSA. Webinar participants will also learn how to prepare their companies for tight reporting timelines and more stringent compliance measures, as well as methods to avoid substantial fines and penalties.
SafetyCall International is an industry leader in adverse event management and post-market surveillance services for industry. For more information about the webinar, new Canadian Consumer Product Safety Act, expert assistance in dealing with adverse events, or for other questions, please contact Kathy Wahlers, Director of Sales and Marketing, 952-852-9503.