The Food and Drug Administration recently released the first major rule under the new Food Safety Modernization Act (FSMA), the proposed Preventive Controls Rule. To help members understand the proposed changes and how they will they affect dairy processors, IDFA will present the "Preventive Controls Webinar" on February 20. The webinar, sponsored by IDFA Business Partner Invensys Operations Management, will be held 1:00 – 4:00 p.m.Clay Detlefsen, IDFA vice president for regulatory affairs, will be joined by Joe Levitt, partner, and Elizabeth Fawell, associate, of Hogan Lovells US LLP. They will outline the key requirements of the new rule, including:
• performing a hazard analysis,
• developing preventive controls for hazards reasonably likely to occur,
• monitoring operations and taking corrective actions and
• verifying that preventive controls are working.
While FDA has issued a proposed rule – and a final rule is still a long way away – the agency has given good insight into how this rule will work. The webinar will explain:
• how the current Good Manufacturing Practices (cGMP's) relate to the proposed rule,
• how FDA will handle warehouses and intentional contamination under this rule,
• what will be required with respect to environmental monitoring and finished product testing and
• what the timeframe is for compliance.
There also will be a question-and-answer period.
