Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA): 2-Day In-Person Seminar

By: Gary E. Ritchie, MS, Director of Scientific Affairs, InfraTrac, Inc.
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Course “Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA)” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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Course Description:

In this two day workshop conference you will learn the various rules regulating the development, manufacturing and quality assurance of products manufactured for animals and humans, the basis of Hazard analysis and critical control points (HACCP) and the preventative measures soon to be enacted for mitigating the exposure of adulterated products to the end user. Steps can be implemented immediately from this course such as ensuring that the personnel have been properly instructed and the training documented on critical control points established for preventing adulterated foods.

Learning Objectives:

Upon completing this course participants should:

  • Read and understand what the expectations are for producers of products intended for animal or human consumption that will be regulated by the FSMA
  • Utilize a risk based approach such as HACCP for developing a strategy for managing the flow of materials through your facility so as to minimize the risk of adulteration during receiving , processing, finishing, storing and shipping intermediates or final product
  • Evaluate the effectiveness of the preventative controls
  • Learn how to use modern control charting techniques to detect trends, and how to respond to and use this information for risk based decision making
  • Learn how conduct an investigation into root cause

FDA Food Safety Modernization Act (FSMA) | Upcoming Developments:
The fundamental elements of the Food Safety & Modernization Act, which will become final August 30, 2015 and official 60 days latter (October 30, 2015 are Produce Safety, Preventive Controls for Human Food, and Preventive Controls for Animal Food and Foreign Supplier Verification Programs.

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Who will Benefit:

Environmental, Health and Safety managers (EHS) and Quality Managers will benefit greatly from this course due to the proximity of the FSMA rule to EHS principles and quality practices already established:

  • Senior quality managers
  • Quality professionals
  • Environmental, Health and Safety managers
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists

Topic Background:

The FDAs from “Farm to Table” initiative is an attempt to minimize exposure to adulterated products to the end users; animals, both livestock and pets, as well as humans. For instance, treating “feed as food,” the FDA FSMA rule proposes monitoring the presence of antibiotics in distillers’ products through routine surveillance sampling or directed sampling and when the results of sampling activities are complete, will continue to make such results available. In addition, controls are proposed to mitigate the risk that animals and humans will be exposed to adulterated products. Preventative Controls which include hazard analysis will be required to identify and evaluate known or reasonably foreseeable feed safety hazards, establish preventive controls to prevent or significantly minimize any “significant” hazards (hazards for which a person knowledgeable in food safety would establish controls), monitor the preventive controls (including written procedures), verify the controls are working, maintain a written food safety plan that incorporates all of the above elements and maintain records regarding the monitoring and verification steps. The second set of controls from current Good Manufacturing Practices (cGMPs) arise from the FDAs quality management systems approach for the food, beverage and drug industry to achieve compliance with the FD&C act where they are focused on mitigation of adulteration out of the following areas and practices: Plant personnel (hygienic practices), Plant construction and grounds (waste disposal, ventilation, easy to clean facility), Sanitation (maintaining plant in good and clean repair, effective pest control), Sanitary facilities and controls (clean/adequate water supply, properly designed plumbing system, hand wash facilities), Equipment and utensils (able to be cleaned and well maintained), Plant operations (proper procedures to prevent contamination) and Holding and distribution (proper containers to avoid contamination, inspection of incoming containers).

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Introduction to the elements of the Food Safety Modernization Act (FSMA)
    1. Preventative Controls
    2. Current Good Manufacturing Practices (cGMPs)
  2. The Food, Drug & Cosmetic Act
  3. Regulatory requirements and expectations
    1. Expected changes
    2. Four Rules of FSMA
  4. Antibiotics in Foods
    1. Regulatory Monitoring
  5. FSMA and Practices
    1. Policies and procedures
    2. Risk Management
      1. Failure Mode Effect Analysis (FMEA)
      2. Hazard analysis and critical control points (HACCP)
Day Two (8:30 AM – 4:30 PM)
  1. Risk Analysis
    1. Hazard analysis and preventive controls
    2. Critical Control Points
  2. Personnel Hygiene Practices
  3. Facility Sanitation
  4. Monitoring
    1. Limits
    2. Trending
  5. Equipment and Utensils
  6. Utility Systems
  7. Sample and test methods
  8. Investigations
  9. Questions

Meet Your Instructor

Gary E. Ritchie
MS, Director of Scientific Affairs, InfraTrac, Inc.

Gary E. Ritchie is Director of Scientific Affairs for InfraTrac, Inc. located in Silver Spring, MD. Gary is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near-infrared and multivariate analysis. Gary has nineteen years of industry experience with increasing responsibility, five years of policy experience and ongoing consulting experience in the pharmaceutical and biopharmaceutical industry. He was Scientific Fellow for Process Analytical Technology (PAT) with the United States Pharmacopeia (USP) and Liaison to the General Chapters, Pharmaceutical Waters and Statistics Expert Committees from 2003 through 2008. As a USP in-house expert on the FDA Process Analytical Technology and Quality by Design Initiative, he was responsible for over thirty Pharmacopeial chapter revisions that incorporated and reflected the revisions by the FDA on the 21st Century cGMP Initiatives. He also led collaborations on several FDA, USP and industry projects that resulted in several Pharmacopeial standards. Gary has more than twenty-five peer reviewed papers and book chapter contributions, four issued patents, numerous industry journal articles and has been invited to give many conference and symposia presentations worldwide. He was President of The Council for Near-Infrared Spectroscopy (2012-2014). Gary holds a Master of Science and Bachelor of Arts degrees in Biology from the University of Bridgeport.

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