Tuesday, July 21, 2020

July 2020 - Contemporaneous Log and Texas Trip

The Vitamin Consultancy eLetter
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COVID willing, my trip to Texas to speak at The Woodlands Lunch Forum to inaugurate the Texas office of the Institute for Health Research is now scheduled for September 10th.  This is the third postponement since February, but I do hope to see my Texas friends then. Tickets available through www.InHeRe.org

KEEPING A CONTEMPORANEOUS LOG
MEETING FDA RECORD KEEPING REQUIREMENTS

The most important step that a small or start-up natural product / dietary supplement company can take to meet regulatory requirements is to keep a Contemporaneous Log of all activities relating to the receiving, handling and shipping of its products.  Follow-up records, such as computer inventory systems or even my OPS for SOPs (Operating Procedures System for Standard Operating Procedures) with its private, password protected regulatory compliance web site -- www.SystemsProcessingIntegration.com -- are after-the-fact records.

What FDA tells us is that the product Label Owner "must be in a state of control" of all processes, whether contracted or handled in-house.  Further the Agency tells us that, "if it is recorded that is how it happened; if it is not recorded it did not happen..."

This means that a contemporaneous, handwritten, initialed Receiving, Handling and Shipping Log is exactly what you need to start off right. Below is the format for the Log, but there are more sophisticated Log formats that I have available and am providing to my regular retainer clients.  Those documents are part of the SOP system developed by The Vitamin Consultancy. Let me know if you need more specifics.

The Log:

Thursday, June 18, 2020

June 2020 - Trip to Texas - Labeling and Packaging Specifications Webinar & eBook


The Vitamin Consultancy eLetter
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IN TEXAS JULY 8 - 12

New Tentative Date:
August 28, 2020

I will be visiting Dallas, Austin and Houston. The sponsor of The Woodlands Lunch Forum, Larry Deckerhoff had this to say:
"Meet You After the Pandemic Reopening -- The theme of this Lunch Forum is Advanced Health for the New Millennium, Immunotherapy and Rejuvenation – Focus on Supercharged Immune Systems During Troubled Times. Among our featured speakers will be Ralph Fucetola JD, President of The Woodlands’ own Institute for Health Research. He will be joined by two experts in rejuvenation and immunotherapies. The short presentations will leave plenty of time to reconnect and enjoy the extraordinary cuisine at Amerigo’s Grille.”
Please contact Stephen with questions:
stephen.contreras1@hotmail.com

LABELING AND PACKAGING SPECIFICATIONS
New Vitamin Consultancy Webinar and eBook
Special Newsletter Price:  $99.00

Contact: ralph.fucetola@gmail.com

Wednesday, May 27, 2020

May 2020 Newsletter: Reopening the Natural Economy

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Although the Declared "Pandemic" is Ending...
EMERGENCY PLANNING SOP & RESTARTING

A couple bits of news...

1.  My trip to Texas to announce the opening of The Woodlands office of the Institute for Health Research - www.InHeRe.org - originally scheduled for February, is now tentatively scheduled for late summer.

2.  The Trump Admin says it is relieving the regulatory burden on businesses to let us get back to work quicker.  My experience has been that FDA has backed-off physical inspections but has continued to push for compliance with previously issued Observation Reports. Use the time you have before the bureaucracy is back to work (well, what they consider "work") and get ready!

3.  I AM AVAILABLE TO CONSULT WITH YOU AS YOU REOPEN.  SPECIAL CONSULTING RATES FOR MAY.  LET ME KNOW -- ralph.fucetola@gmail.com with Consulting in subject line.

No doubt future inspections will put more emphasis on company Emergency Planning.

I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.

My regular retainer clients received a copy of the revised SOP last month and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.

Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency! CONTACT ME ABOUT SETTING-UP YOUR OPS 4 SOPs PAGE TODAY!

If you want a copy of SOP #13, the cost is now just $69 -- email me and I'll send you a PayPal money request.
I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP):  "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."

Please let me know how I can help your company as the emergency ends.

Dr. Laibow and I are maintaining a COVID information aggregation site here:  www.TruthAboutCoronavirus.com

We also held a COVID Emergency Health Summit (over 6 hours of podcasting with a half dozen experts) - more information here:  http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/
HERE IS WHAT AN OPS FOR SOPS PAGE CAN INCLUDE:

Thursday, April 30, 2020

April 2020 Newsletter: Quality Counts

April 29, 2020

SPECIAL BONUS eBOOK!
Labeling and Packaging Specs
-----

Here is the LINK where you can download my latest eBook which explains how to keep a Labeling and Packaging Log in conformity with GMPs -- as provided in SOP #25 of the Vitamin Consultancy standard SOP format.

http://www.vitaminconsultancy.com/Labeling-%26-Packaging-Specifications.pdf

-------------------------------

QUALITY COUNTS!
And Increases Your Bottom Line
Nutrient Sales Surge During Declared Pandemic

Quality Counts!
New ETQ Survey shows:  "An important shift is happening. Organizations now treat quality as a strategic initiative. Survey data shows 66% of organizations categorize quality as a strategic growth investment. Treating quality as a strategic business initiative is paying off as organizations see an average return of 23% on their investments."

Since Quality Counts, Quality Control must be a central concern.  Under FDA's GMP there is no question that quality counts and that the product label owner is the responsible party for quality control.  Your company needs to have Quality Control built into its Standard Operating Procedures (SOPs) and you need to have a designated Quality Control Manager.

The Vitamin Consultancy's standard SOPs include strong quality control provisions.  In the vitamin industry, according to numerous FDA Form 483 Inspection Observations that means controlling "identity, purety, strength and composition" of the DSHEA product.

Here is what the SOP says about the QC Manager: "The QC Manager shall review and evaluate with the company managers at least annually complaints, recalls, returned or salvaged products and internal investigations conducted for each."

QC Goals include:
  • Qualifying the Contract Manufacturer as capable meeting quality, strength, purity and identity standards
  • Approving (or rejecting) products manufactured, processed, packed or held under contract by another company
  • Approving (or rejecting) procedures and specifications impacting identity, strength, quality and purity
  • Approving (or rejecting) packaging, labeling and product containers
  • Reviewing and investigating consumer complaints.
Contact me at ralph.fucetola@gmail.com and let's talk about brining your SOPs up-to-date.  During this enforced period of self-shielding is a perfect time for you to get ready to get back to work! 
Learn more about my Systems Processing Integration!
I make being organized easy!
 www.SystemsProcessingIntegration.com
Stay safe and for the latest from Dr. Rima and me on COVID-19 check www.TruthAboutCoronavirus.com (if your browser says the site is "dangerous" it is right, but not a danger to you); alternatively, check www.OpenSourceTruth.com

http://www.opensourcetruth.com/covid-second-wave/

Friday, March 27, 2020

March 2020 Newsletter #2

This Issue:
Pandemic Protective Masks
My Latest OST Article
Planning for After the Pandemic

PANDEMIC!
Dr. Rima: We Have Bulk Protective Masks

Everyone is worried about COVID-19 and every company is impacted by it. And we all want to help.  Dr. Rima has sourced bulk amounts of protective masks.  If you know institutional buyers, now is the time to let them know.

Here is the link:
http://drrimatruthreports.com/save-health-workers-lives-today/

The web page includes a product brochure with full details.

And this link to my earlier March newsletter with an important article about Emergency SOP with Working Remotely provision:
http://vitaminlawyerarchives.blogspot.com/2020/03/march-2020-pandemic-newsletter.html
 

My latest article on Open Source Truth:
http://www.opensourcetruth.com/has-the-covid-curve-peaked/

 

PLANNING YOUR BUSINESS REBOOT AFTER THE PANDEMIC
While you are working from home it's time to plan your post-pandemic come-back.  It may help your planning if you consider your dietary supplement consumer's expressed interests.

https://www.nutraingredients-usa.com/Article/2020/03/25/Worldwide-supplement-survey-highlights-key-consumer-trends

2019 Worldwide supplement survey highlights key consumer trends - 25-Mar-2020 By Danielle Masterson

Glanbia Nutritionals surveyed users from across the globe to better understand consumer motive, usage, and knowledge gaps. US, UK and China consumers who used vitamins regularly.

US users listed top reasons to purchase:

55% - General Health
37% - Heart Health
32% - Healthy Aging
23% - Mental Health


In the 18 - 34 age demographic brain/cognitive health a top concern; 55 - 70 group: healthy aging and sleep support

Top vitamins used worldwide: C, D and Calcium; Q10, K2, choline and biotin had high consumer interest

Now that's some food for thought... or thoughts about nutrient foods. You get it.  Plan from data.

Friday, March 13, 2020

March 2020 Pandemic Newsletter

PANDEMIC!

EMERGENCY PLANNING SOP

Everyone is worried about COVID-19 and every company is impacted by it.

I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.

My regular retainer clients are receiving a copy of the revised SOP and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.

Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency!

If you want a copy of SOP #13, the cost is just $99 -- email me and I'll send you a PayPal money request.

But during this emergency, I want everyone to have the information they need to protect their company.  So here is the new section of SOP #13, so you can get ready for remote working if you find your company under lock-down.
---------------------------------------

[2] Working Remotely - It may be necessary for some or all staff to work remotely during an emergency.  In advance of such contingency the Emergency Manager should:
  1. Establish an Online Communication System, such as (1) Skype or Zoom, instructing all staff to have access to the system via cell phone and home computer; (2) a Conference Call Bridge number should also be established and (3) a Push Notice System can be established to text group messages to staff member cell phones.
     
  2. Designate staff members who are essential to operations and who should, if possible, work from the facility.
     
  3. Designate staff members who can continue their work remotely.
     
  4. Designate times and circumstances where staff members should call the Conference Call Bridge for instructions or text instructions to staff members’ cell phones.
I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP):  "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."

Please let me know how I can help your company during this emergency.

Dr. Laibow and I are maintaining a COVID information aggregation site here:  www.TruthAboutCoronavirus.com

We are planning a COVID Emergency Health Summit; more information here:  http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/

Friday, February 14, 2020

Cost Segregation and Your Business

The Vitamin Consultancy eLetter
February Texas Trip, Cost Segregation
Systems Processing Integration
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COVID-19 DELAYS TRIP
I'LL BE IN TEXAS
LATER THIS MONTH

My February Trip to Texas is NOT going ahead as planned. Instead, COVID-19 permitting, I'll be in the Lone Star State from 5 May through 9 May 2020 -- traveling from Dallas through Austin to Houston where I am the featured speaker at The Woodlands Lunch Forum on Friday, May 8th.  More about that event here:   https://www.woodlandsonline.com/npps/story.cfm?nppage=65447 -- if you are going to be in the area, I'd love to see you!
Do you want to save money on your business Income Taxes? 

OF COURSE YOU DO!

Our Financial Services can help you accelerate your real estate depreciation through an engineered Cost Segregation (Cost
Seg) Study allowing you to expense 10% to 50% of the cost of your building in the FIRST YEAR

 
The TAX saving is guaranteed by Urb Financials to be ten times the cost of the study! 
 
What is Cost Seg?  CLICK HERE

How does Cost Seg benefit you?  CLICK HERE
 
What is the IRS’ position on Cost Seg?  CLICK HERE 

"Some taxpayers are reluctant to use cost segregation, equating it with a high-risk tax shelter. In truth, this reluctance is misplaced. If the cost of the components in the engineering report is well- documented, the cost segregation technique is no more aggressive than using a permissible depreciation method under the Internal Revenue Code." Journal of Accountancy
 
Advanced Strategies and FAQs? CLICK HERE 


THE PRELIMINARY COST SEGREGATION ANALYSIS IS FREE.
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Once completed, please return Estimate Application Formn to GET at dannyfucetola@gmail.com and typically within ten business days of receipt of your completed form, we will provide you with a FREE Preliminary Analysis containing the estimate of the income tax benefits and projected cost of a Cost Segregation Study.
SYSTEMS PROCESSING INTEGRATION
DEFINING REGULATORY COMPLIANCE!
My experience will strengthen your company!  I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about dietary supplements (including medical foods) and/or providing health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet FDA procedural regulations.
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