Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

• FDA cGMP QSR GMP Training - online training classes by SkillsPlus International Inc.

Read the full article:   Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

According to the article:

"The FDA originally published a Notice of Proposed Rule Making (NPRN) in May 2018. The abstract from Regulation Identifier Number (RIN) 0910-AH99 states: “FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufactures, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.” The NPRM is currently at the Proposed Rule Stage with an action date in October 2020. A panel committee meeting will be held after issuance of the proposed rule."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA Signals Strengthening Regulation of Dietary Supplements - FDA.gov

• cGMP Training and FDA Training Courses by SkillsPlus Intl Inc.

Read the full press announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Snippets from the FDA Commissioner's statement:

". . . we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA - Proposed Rules To Implement FSMA

Food and Drug Administration logo (Photo credit: Wikipedia)

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

Updated December 19, 2020

You might also be interested in:

Frequently Asked Questions on FSMA - FDA.gov

- - -  original post follows below  - - -

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

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around