Description

Food Manufacturing, processing, and distribution are considered a critical operations in a crisis, however, the current global pandemic has made it near impossible for food safety professionals and auditors to perform their normal routine inspections and checks. Many certification programs have granted extensions; however, these lapses have put more pressure on manufacturers to ramp back up quickly for FSMA PC audits by FDA inspectors, many of which are not prepared since COVID. We will cover all the minimum requirements along with best practices to successfully navigate this audit, avoiding a #483.

Learning Objectives:-

• Expectations covered for new requirements for FSMA Audit by Regulators
• COVID landscape
• New Hazard Analysis Risk Preventative Controls (HARPC) or Food Safety Plan basics introduced
• Supply chain Preventative Controls outlined
• Legal Authority of FDA detailed, including watch-outs
• Importance of documentation requirements described
• Employee preparation and training essentials explained
• Closing a Successful Audit, including managing #483’s and confidentiality

Background:-

Current Pandemic forcing the Food & Beverage Industry to think out of the box to ensure the safety of our food products, resulting in reliance on new checks and balances based on weighing an array of risks built on long-standing GMP’s and Best Practices. FDA is starting to perform unannounced audits once again, are you ready

Why Should You Attend:-

FDA implemented the Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help the industry manage potential hazards in producing safe food products. Since then, in midst of rollout COVID Pandemic struck and placed audits in limbo. We will examine FSMA requirements, learnings coping with COVID, and go-forward plans, especially with the new administration.

FSMA places primary responsibility on the owners and operators of food facilities to identify and control hazard risks, and intentionally grants facilities considerable flexibility in designing and implementing their food safety plans. In light of these new regulations, FDA introduced an enhanced audit approach to ensure food processors have adequately eliminated these potential risks in their food facilities. This course will examine new FDA authority, introduces examples of Preventative Controls, leading to minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483 for non-compliances

Who Should Attend:-

Quality and Food Safety staff/mgt., PCQI members, Operations leads/supervisors, Sanitation leads/supervisors, plant management, warehousing managers/leads, maintenance and engineering leads/supervisors, procurement team leads, crisis coordinators, company leadership, risk managers, senior leaders