Tuesday, January 22, 2019

It's a New Year - Time to Audit Your Compliance to Changing Regulations

It's a New Year - Time to Audit Your Compliance to Changing Regulations
Your Company MUST have a PCQI
New Food Safety Training Webinar

FDA's Food Safety Regulation requires a written plan and a trained PCQI - Preventative Controls Qualified Individual. I have you covered.

I prepared a 15 page Food Safety Plan that closely tracks the Regulation, 21 CFR 117.126. Then I prepared an 18 minute training webinar and eBook, along with a certification test. If you pass, you receive a PCQI Certification of Completion of the training.

The Certification Training Program is structured to introduce the trainee to a standard Food Safety Plan under FDA regulations. All registered food facilities are required to have a written Food Safety Plan in place and in operation. After completing the webinar and reviewing the Food Safety Plan Format and the eBook, contact me to receive the Certification Test, and upon completion and return of the test, the Preventative Controls Qualified Individual (PCQI) Certification will be provided.

Is your company required to register as a food facility [and is therefore required to have a Food Safety Plan]? If you handle food, yes.

This certification program, including the Food Safety Plan, eBook and webinar training, is priced at $600 -- but, for recipients of the Vitamin Consultancy Newsletter, I am offering a 50% Discount, if purchased during the month of January, 2019. Just email me at: ralph.fucetola@usa.net with "FSP" in the subject line.

Says the FDA: “The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule) (80 FR 55907). This final rule became effective on November 16, 2015. It creates new requirements for the production of human food by registered food facilities... The intent of this guide is to inform domestic and foreign food facilities about the PCHF regulation and enable them to better understand the requirements of the rule. The rule is binding and has the full force and effect of law.”

The Regulation provides that the Plan shall contain the following Contents:
(1) The written hazard analysis as required by § 117.130(a)(2);
(2) The written preventive controls as required by § 117.135(b);
(3) The written supply-chain program as required by subpart G of this part;
(4) The written recall plan as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a)(1);
(6) The written corrective action procedures as required by § 117.150(a)(1); and
(7) The written verification procedures as required by § 117.165(b).
The Plan has 22 separate sections. The PCQI must be a manager of the company and must be trained, with proof of training.

Horizon v Jonuzi et al. 
Last month the case survived a Summary Judgment Motion.

This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods. This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.

From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why the Institute for Health Research is sponsoring crowdfunding support for the litigation. [Note: I am not the attorney of record on this case.]

Read more here: https://vitaminlawyerhealthfreedom.blogspot.com/2018/12/provider-nondiscrimination-case.html

Please read about it, and help our crowdfunding effort. This case is quite important!

Donate here: https://fundly.com/support-natural-therapies

And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers. www.inhere.org/institutional-review-board/