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FDA’s Proposed Preventative Control Regulation for Human Food under FSMA- 21CFR Part 117 and What You Should Know Now to Prepare for When it Becomes Effective in 2015

Instructor: Brian Hendrickson
Product ID: 703706
  • Duration: 90 Min

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Read Frequently Asked Questions

This webinar will summarize the regulatory requirements for FDA’s proposed new regulation – “Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Human Food” - 21CFR Part 117. The GMP component of this regulation (Subpart B) is intended to replace the current outdated GMP regulation (21CFR Part 110) when it becomes effective, as expected, in 2015.

Why Should You Attend:

Part 117, Subpart B (GMPs) contains some new requirements for food processors not required by Part 110. Many definitions in the current Part 110 have been changed or added in the new rule to make it more in sync with current food safety problems. FDA especially emphasizes some new definitions as important in controlling hazards reasonably likely to occur and having the potential to cause serious adverse health consequences or death to consumers.

The webinar will present a brief overview of Part 117 to provide a perspective of how Subparts B and C work together in a proactive way to achieve food safety by preventing adulteration from occurring in food that is manufactured, processed, packed or stored. It includes the presentation of a class 1 recall scenario where serious hazards are detected in processed food lacking effective preventative controls and the application of Subpart C to identify and reduce hazards reasonably likely to occur to ensure regulatory compliance. It will provide a perspective of how to construct a food safety plan with effective preventative controls to reduce or eliminate food safety hazards reasonably likely to occur as identified in the scenario.

Attending this webinar will provide important information to food facilities that manufacture, process, pack and hold human food to enable them to prepare for this new proposed preventative controls regulation for human food, Part 117.

Learning Objectives:

  • Obtain a basic understanding of FDA requirements specified in the new GMP regulation Part 117 as compared to the old Part 110
  • Understand the new terminologies added in the new Part 117
  • Understand how Subpart C works in a proactive way to ensure regulatory compliance with Subpart B
  • Understand the importance of the new rule in promoting food safety
  • Understand the exemptions from compliance with Subpart C in the new rule

Areas Covered in the Webinar:

  • Brief overview of the new GMP regulation requirements under FSMA – Part 117 as compared to the old GMP requirements under Part 110
  • New terminologies used in the new Part 117 vs. the old Part 110
  • The importance of Part 117 in controlling the safety of processed foods
  • How to use Subparts B and C to prevent food adulteration
  • Exemptions for certain facilities under Part 117
  • How failure to comply with the new GMP regulation can affect food facilities that manufacture, process, pack or store human food

Who Will Benefit:

This webinar will provide valuable assistance to personnel working with food manufacturers and facilities responsible for packaging/labeling food products, including:

  • Plant managers
  • Quality control managers and employees
  • Production managers and employees
  • Microbiologists
  • Scientists
  • Consultants
  • Regulatory affairs experts
  • Food technologists
  • Food safety personnel
  • Food inspectors
  • Marketing staff
  • QA/ QC staff
  • Food warehouse managers
  • Raw material and ingredient suppliers
  • Importers/exporters
  • Food testing laboratory personnel

Instructor Profile:

Brian Hendrickson is a retired FDA National Food Expert with more than 35 years’ experience with the agency. As a national expert, he helped develop FDA regulatory policy for high-risk foods and trained FDA and state food inspectors nationwide in food technologies and related hazards, FDA regulations and inspection techniques. He has conducted FDA inspections of food manufactures internationally. Since his retirement in 2011, Mr. Hendrickson has been self-employed as a food industry consultant, served a 3-year appointment as assistant professor of food science at Purdue University, and taught food safety courses at Purdue and 4 other universities nationwide.

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