IEH Academy

Rendering of clay animation on The Impact of FDA and USDA Reduction in Force on Regulated Industries.

IEH Academy Webinar

The Impact of FDA and USDA Reduction in Force on Regulated Industries

This webinar examines how staffing reductions at the FDA and USDA affect core regulatory functions related to food safety and nutrition. Attendees will review how slower response times, stalled guidance, and reduced oversight may disrupt compliance and shift risk back to industry. 

Webinar Recording

Description

The session outlines what regulated companies should expect and how to stay prepared

Benefits and Learning Objectives:

  • Characterize Clostridium botulinum and its relevance in foodborne illness
  • Analyze the impact and public health consequences of botulism
  • Examine regulatory requirements for botulism prevention under 21 CFR Parts 108 and 109 and 9 CFR Part 431
  • Understand the role of formulation and processing in limiting C. botulinum growth

Topics Covered:

  • Navigating extended regulatory review and approval timelines
  • Assessing the impact of reduced inspection frequency and response
  • Examining the delayed issuance of guidance documents and policy updates
  • Understanding compliance and business risks tied to workforce reductions

Who Should Attend

  • Food and animal product manufacturers (domestic and foreign)
  • Importers and exporters subject to FDA or USDA oversight
  • Regulatory affairs professionals
  • Quality assurance and quality control managers
  • Operations and compliance managers
  • Legal and risk advisors in the food industry
  • Consultants supporting FDA and USDA regulated industries
  • Professionals involved in responding to inspections, enforcement actions, or regulatory submissions

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 Impact of FDA and USDA Reduction in Force on Regulated Industries. This interactive portion is designed to offer personalized guidance and facilitate the sharing of practical insights among participants.

Carol Cave

Meet the Instructor

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.

Carol Cave

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.

Let's get in touch

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