Overview
A product recall is often the best option to protect consumer safety and reduce the risk of liability for pharmaceutical manufacturers and distributors. This webinar will address best practices for the whole life cycle of the recall including investigation of potential product issues, deciding when to conduct a recall, reporting to regulatory authorities, implementing the recall, and evaluating effectiveness. We will use case studies to evaluate different recall situations and identify elements of a successful crisis management strategy.
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Speakers
Doris Chin, Lead Consumer Safety Officer, Incidents, Recalls and Shortages Branch, Office of Drug Security, Integrity, and Response, CDER, FDA
Ileana Elder, Incidents, Recalls and Shortages Branch Chief, Office of Drug Security, Integrity, and Response, CDER, FDA
Ryan Gooley, Product Recall Advisor, Sedgwick
Moderated by Kalah Auchincloss, Executive VP and Deputy General Counsel Greenleaf Health, Inc.
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Speakers
DORIS CHIN is currently a Lead Consumer Safety Officer, in the Division of Supply Chain Integrity, Office of Drug Security, Integrity and Response, Office of Compliance, Center for Drug Evaluation and Research. She has been with the Recalls and Shortages Team since she joined the Agency in 2009, where she reviews and classifies human drug recalls and coordinates the Office of Compliance’s assessment of drug shortages in collaboration with the Drug Shortages Staff to mitigate or minimize shortages in the US marketplace. Before joining the Agency, she worked both in independent and retail pharmacies as a pharmacist. Doris graduated with a Bachelor of Science degree in Pharmacy from the University of Maryland at Baltimore School of Pharmacy.
ILEANA ELDER is currently the Incidents, Recalls and Shortages Branch Chief, in the Division of Supply Chain Integrity (DSCI), Office of Drug Security, Integrity and Response (ODSIR), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER). In this position, Ileana supervises the Recalls & Shortages Team responsible for review and classification of all human drug recalls and coordination of OC’s assessment of drug shortages in collaboration with the Drug Shortages Staff (DSS) and the Incidents Management Team responsible for OC coordination of events involving human drugs that pose a significant threat to public health. Before joining CDER as a Branch Chief, Ileana was the Postmarket Team Leader in the Division of Chemistry and Toxicology Devices (DCTD), Office of In Vitro Diagnostics and Radiological Health (OIR-OHT7), Center for Devices and Radiological Health (CDRH). In this position, she led a team of regulatory officers responsible for recall classifications, complaints and Establishment Inspection Reports (EIR) review, review of Medical Device Reports (MDRs), issuing Warning Letters, and review of Premarket Approval (PMA) supplements associated with diabetes management devices, drugs of abuse and therapeutic drug monitoring devices, pharmacogenetics testing device, and cardiac/heart failure markers testing devices. Ms. Elder received a Bachelor of Science degree in Industrial Chemistry from the University of Puerto Rico, Humacao, Puerto Rico and a Doctoral Degree (Ph.D.) in Biomedical Sciences from the University of Florida, Gainesville, Florida. Ileana is an American Society for Quality (ASQ) Certified Quality Auditor (CQA). She also has a Regulatory Affairs Certification (RAC) and is a certified Six Sigma Green Belt by the Regulatory Affairs Professionals Society (RAPS).
RYAN GOOLEY is a Product Recall Advisor for Sedgwick Brand Protection Solutions (formerly Stericycle Expert Solutions), where he has played a vital role in the execution of over 1,500 recalls, withdrawals and market corrections for some of the highest profile food and beverage, consumer product, and pharmaceutical companies globally. Throughout his 16+ years in the product recall management industry, Ryan has led clients through every step of the recall process and other crisis related events. With many global clients, Ryan’s work has contributed to the successful resolution of hundreds of international product recall efforts over the course of his career.
KALAH AUCHINCLOSS is Executive Vice President, Regulatory Compliance and Deputy General Counsel at Greenleaf Health, Inc., where she advises clients on compliance, policy and regulatory issues. She has 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at FDA, including, as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office. Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues. Before joining FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. As an Executive Vice President at Greenleaf, Kalah is continuing her commitment to public health by providing strategic counsel to clients on compliance, enforcement and policy matters. Kalah holds a BA with honors from Williams College, a JD with honors from Georgetown University Law Center, and an MPH from Harvard University.
