IEH Academy Webinar
FSMA Whistleblower Provision:
A Responsible Approach to Complaint Management
Well informed food processors and distributors recognize the critical importance of tracking every ingredient and packaging material in their portfolios.
Many have been implementing traceability systems for years to ensure both regulatory compliance and product safety. This long standing commitment to traceability became even more critical when Congress passed the Food Safety Modernization Act over a decade ago, mandating the FDA to identify specific foods requiring detailed recordkeeping to protect public health.
- May 29th, 2025
- 11:00 AM - 12:00 PM PST / 2:00 PM - 3:00 PM EST
- Dr. Don Zink & Carol Cave
- Sharon Mayl & Perham Gorji
Webinar Recording
Description
Join us for a lively discussion on the Food Safety Modernization Act (FSMA) Whistleblower Protection Provision. Attendees will learn about which entities are covered, how to assess reasonable belief that a violation of the FD&C Act has occurred, and suggestions on managing FSMA whistleblower complaints in accordance with regulatory standards.
Topics Covered:
- Understand the FSMA Whistleblower Protection Provision
- Examine which entities are covered under the provision
- Learn what constitutes a protected activity
- Identify what makes food adulterated or misbranded under the FD&C Act
- Recognize retaliation and its consequences
- Analyze the roles of OSHA and FDA in managing whistleblower complaints
- Establish appropriate procedures for handling whistleblower complaints responsibly
Who Should Attend
- Supervisors and managers responsible for overseeing food product workers
- Compliance officers ensuring FSMA compliance
- Legal and HR teams handling whistleblower complaints
- Quality assurance and regulatory affairs professionals
- Professionals involved in food safety and regulatory compliance
Webinar Length
1 hour with Q&A to follow.
The webinar will include a 10-minute Q&A session where attendees can ask questions related to the The Traceability Rule. This interactive portion is designed to offer personalized guidance and facilitate the sharing of practical insights among participants.
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President, Food & Regulatory Compliance
IEH Laboratories & Consulting Group
Meet the Instructors
Dr. Donald Zink
Dr. Donald Zink leads the food safety and food processing consulting group at IEH. He received his Ph.D. in Biochemistry and Biophysics and his M.S. in Microbiology from Texas A&M University, and his B.S. from Abilene Christian University.
Prior to working at IEH, Dr. Zink worked for the U.S. FDA as the Chief Scientist for Food Safety and Applied Nutrition. At IEH, he is focused on helping clients avoid food contamination from bacterial pathogens. Dr. Zink assists clients with broader issues related to food safety such as: process validation, allergen control, and chemical contamination.
He is an expert in the microbiological and chemical safety of processed foods and fresh produce. He has extensive experience on low acid canned food thermal processing, aseptic processing, ice cream production, chocolate and confectionery products, infant formula production, beverage production, fermented and acidified foods, frozen and refrigerated food production, and baked goods production.
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Executive Vice President
IEH Laboratories & Consulting Group
Carol Cave
Ms. Carol Cave joined IEH as the Executive Vice President in 2024, bringing with her extensive expertise in regulatory affairs and consumer protection. She holds a B.S. in Consumer Economics from the University of Maryland.
Before joining IEH, Ms. Cave served as the Acting Associate Commissioner (ACRA) for the Office of Regulatory Affairs (ORA) at the Food and Drug Administration. In this role, she oversaw approximately 5000 ORA employees stationed across the U.S. and around the world.
Prior to her role as Acting ACRA, Ms. Cave served as Deputy Associate Commissioner, where she managed inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning.
Earlier in her career at the FDA, she served as the Assistant Commissioner of Import Operations, where she led the Office of Enforcement and Import Operations, ensuring FDA-regulated imported products comply with U.S. laws. Ms. Cave also led coordination efforts between the FDA and U.S. Customs and Border Protection, developing joint regulations, policies, procedures, and operations.
Before her tenure at the FDA, Ms. Cave was the Deputy Director of the Office of Compliance and Field Operations at the U.S. Consumer Product Safety Commission (CPSC). In this role, she collaborated with federal government agencies to identify potentially defective consumer products. With nearly 26 years at the CPSC, Ms. Cave held various leadership positions, including Director of State and Local Programs and Assistant Executive Director for the Office of Import Surveillance, ensuring the safety of consumer products nationwide.
- Partner at DLA Piper
Meet the Guest Speakers
Perham Gorji
With more than 20 years of federal service, including nearly a decade as the Deputy Chief Counsel for Litigation at the US Food and Drug Administration (FDA) and a dozen years combined as a Department of Justice (DOJ), Consumer Protection Branch (CPB) trial attorney and Assistant U.S. Attorney, Perham Gorji has extensive litigation experience and a deep understanding of the FDA’s regulatory goals and methods of enforcement.
With his unique level and breadth of experience at FDA and DOJ, Perham has the judgment and skills necessary to guide clients through significant litigation and investigations and manage the reputation risks they present. In addition to overseeing a firm’s response to an enforcement action, his administrative and regulatory experience at the FDA enables him to help clients properly respond to and resolve warning letters, import alerts, and other regulatory actions. Perham is able to advise clients as they navigate the FDA inspection process, including product application inspections, routine inspections, for cause inspections and supervision inspections pursuant to an FDA consent decree or other government compliance agreements, and clients benefit from his insider’s understanding of the factors that inform agency decisions to move matters from the regulatory inspection phase, to warning letters and/or enforcement.
Perham’s work has involved the full gamut of FDA regulated medical products, and he has the experience and skills necessary to evaluate these product offerings and manufacturing processes for compliance with the statutes and regulations that govern them. He is able to assist clients to establish and maintain robust compliance programs and attain a long-term culture of adhering to the US Department of Health and Human Services (HHS) and FDA regulatory requirements.
- Partner at DLA Piper
Sharon Mayl
With more than 25 years of experience as a senior advisor at FDA, Sharon Mayl advises clients in the areas of in the areas of food and ingredient safety, imports, third-party audits, nutrition labelling, dietary supplements, infant formula, and cannabis products. She applies her insider experience to help clients navigate the black box of FDA, finding strategic and practical solutions to complex regulatory and compliance problems.
Sharon provides strategic advice and regulatory counsel to clients in a variety of areas, including the FDA Food Safety Modernization Act (FSMA), ingredient and product development, supplier verification, nutrition labelling and claims, infant formula development, and dietary supplements, she also advises cosmetics clients on compliance with the Modernization of Cosmetics Regulation Act (MoCRA), labelling and safety issues. Sharon uses her decades of experience at the agency to assist clients with FDA interactions and meetings, including with respect to policy development and compliance actions such as warning letters and inspection reports.
During her time as a senior advisor in the Commissioner’s Office, Sharon advised several deputy commissioners on a wide range of regulatory, legislative and policy issues. Sharon played a leading role in implementing FSMA and developing strategic approaches to imports, the Nutrition Labelling and Education Act, cannabis policy. She regularly represented the agency in meetings with senior administration officials, Congress, federal and state regulatory agencies, foreign governments, industry representatives and consumer and public health groups. In these cross-organizational efforts, she established herself as a top government official in her space and forged close and cooperative relationships to achieve solutions to novel, controversial and complex issues. Sharon has received numerous awards and distinctions for her public service, including the Commissioner’s Award of Excellence for her outstanding contributions to food safety and imports.
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