Good Manufacturing Practices
All companies that manufacture, process, pack, and/or hold food intended for consumption in the United States must comply with GMP requirements, whether foreign or domestic. They apply even to companies subject to other FDA regulations, such as Juice or Seafood HACCP. This one day workshop educates attendees on the requirements of current FDA Good Manufacturing Practices (GMPs or cGMPs), as defined in 21 CFR 117 Subpart B.
This course explains the requirements of FDA GMPs, with a focus on the changes from 21 CFR 110 to 21 CFR 117. New sections will include Human Food by-products for use as Animal Food and common misconceptions about areas of renewed focus (like allergen management). We tailor each workshop to the needs of the attendees and discuss examples from the industries represented within the class. The workshop includes real-life examples whenever possible; no two D. L. Newslow & Associates, Inc. workshops are ever quite the same.
Who Will Benefit
Quality Assurance, Regulatory, Production, Maintenance, Management, Supervisors, Front Office staff, and any other employees of a facility that manufactures, processes, packs, or holds human or animal food intended for consumption in the US should take this course. GMP requirements apply to every individual employed in the facility, contractors, visitors, etc., so everyone should have a comprehensive understanding of the regulatory requirements.
What You Will Learn
- The requirements of 21 CFR 117 Subpart B (current FDA Good Manufacturing Practices)
- Changes from 21 CFR 110
- Tips to increase compliance when management is not on the floor
- Common misconceptions and miscommunications related to the new requirements
- How to train others in your facility upon your return
- How to do GMP walkthroughs to judge on-going compliance
If you are interested in having us present a customized workshop specifically designed for your organization at your site, please call us at (407) 290-2754.