Event

Overview

The FDA is responsible for the oversight of nearly $3 trillion in food, medical products, and tobacco consumption, and with that, the warehouses and facilities these consumer products are held in prior to shipping. The webinar will provide attendees with an overview of the FDA’s warehousing regulatory requirements and offer strategic recommendations for compliance with those rules. The webinar will also provide an update on the U.S. Department of Labor’s Occupational Safety and Health Act’s (“OSHA”) warehousing enforcement-related activities and standards. Our panel of attorneys will discuss how to prepare for inspections and give attendees access to a free inspection model guideline.

Why Should You Attend

Those looking to gain an understanding of FDA and OSHA’s requirements that apply to warehouses should attend.  The information provided will help companies design and update compliance programs to ensure that applicable regulatory requirements are satisfied. FDA topics covered will include the types of companies that are required to register with FDA, a broad overview of the current Good Manufacturing Practices (cGMPs) that must be followed, and strategies for reducing the risk of enforcement action. Individuals who are interested in learning what OSHA Standards and Regional Instructions apply to warehouses should also attend. Finally, the program will help companies better prepare for agency compliance inspections by providing an example of a regulatory compliance program and inspection module. 

Learning Objective

• Who must register with FDA (warehouse, distributor, fulfillment center, 3PL)
• Which FDA requirements apply to warehouses
• An understanding of recent enforcement action in this area
• The different current Good Manufacturing Practices (cGMPs) that apply to warehouse
• The OSHA regulations and standards covering these facilities
• Strategies for planning for facility inspections and how to be successful

Webinar Takeaway

• FDA Regulatory Law
• Food, Dietary Supplement, Cosmetic, and OTC Warehousing
• Current Good Manufacturing Practices
• Recent Enforcement Action Examples
• The U.S. Department of Labor’s Occupational Safety and Health Act’s (OSHA) requirements for warehouses and distribution centers
• Strategies for a successful facility inspection 

Who Will Benefit

• Regulatory Affairs
• Legal
• Managers and Supervisors
• Compliance Officers
• Directors of Quality Assurance
• Inspectors and Auditors
• Attorneys