FDA Final Rule on Combo Product CGMPs - New!

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Hot off the press!

This final rule clarifies which CGMP requirements apply when drugs, devices, & biological products are combined to create combination products:

Current Good Manufacturing Practice Requirements for Combination Products - A Rule by the Food and Drug Administration on 01/22/2013

In a nutshell:

The FDA is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

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• FDA - Proposed Rules To Implement FSMA (skillsplusinfo.blogspot.com)

FDA - Proposed Rules To Implement FSMA

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• FDA cGMP QSR GMP online training - popular cGMP online training courses provided by SkillsPlus International Inc.

Updated December 19, 2020

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Frequently Asked Questions on FSMA - FDA.gov

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The FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA). The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, and 
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

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Online GMP Training - 21 CFR 820: Essential Elements

Updated October 28, 2018

The original post didn't age very well.

You might be interested in the current selection of SkillsPlus International Inc's FDA QSR cGMP training courses and workshops

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Take this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.

21 CFR 820: Essential Elements on the Computer-Based Training page by SkillsPlus International Inc.

This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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