Thursday, December 17, 2009

12/17/09 - H1N1 Spurs Vitamin Sales / Clinical Trial Meetings / CAPA Outline

0.  Blog & News – Opportunity to Meet Gen Bert & Dr Rima; CAPA
1.  H1N1 Spurs Vitamin Sales
2.  Natural Clinical Trials Center
3.  Vitamin Lawyer Webinars
Addendum: CAPA Outline

Blog & News – Rare opportunity to meet with Gen. Stubblebine and Dr. Laibow in the NYC metro area after New Year’s Day. Kevin Trudeau, Dr. Coldwell, others to attend…

For the Weekend Intensive (January 2nd and 3rd) see
2010 Health Freedom USA War Council
www. healthfreedomusa .org/?p=4183

Private meetings with Dr. Laibow and Dr. Goodman and myself for Natural Clinical Trials are available on Monday, January 4th, in person or electronically. Please contact me at for details if your company is interested in discussing Clinical Tests, Studies and Trials.

Dr Laibow and Gen Stubblebine have a Holiday video message for you:  www .healthfreedomusa .org/?p=4157


CAPA SOPs– Corrective and Preventative Actions Standard Operating Procedures

CAPA is an essential element in cGMP SOPs. Outline below; let me know if you need a formal SOP. As my Holiday Gift to my client base, I’ve included, at the bottom of this eblast, my CAPA notes for the CAPA SOP and webinar being planned.

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]

1. H1N1 Fuels Supplement Sales Around the Globe, NBJ Research Shows

Nutritionbusinessjournal .com/nutrition-industry/news/H1N1-supplement-sales-nutrition-business/

“December 15, 2009 - Total global nutrition industry sales increased 8% to $270 billion in 2008, and sales are expected to rise another 6% to 10% this year, According to Nutrition Business Journal estimates. On the supplement front, the outbreak of the fear-provoking H1N1 flu pandemic, which surfaced in Mexico in April 2009 and touched nearly every country in the world by August, is helping to lift sales all over the globe.

The rapid spread of H1N1—which has already infected an estimated 1.3 billion people worldwide—is causing a spike in immune-support supplements around the world, as people scramble for anything that could help keep the virus at bay. “In recent months, global health concerns, including H1N1, have resulted in a high demand for general health and immunity products,” said Richard Henfrey, director of people and strategy at Australian supplement company Blackmores, whose sales are up more than 12% this year. Similar comments were made by nutrition industry executives from South Korea to Germany to the Philippines to South Africa...”


2.  Natural Clinical Trials Center

Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.

Dr. Laibow, Dr. Goodman and I are available for in-person or virtual conferences on Monday, January 4, 2010 to discuss Clinical Tests, Studies and Trials. Please email me ASAP if you have an interest in reserving time.


3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up:

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).


Natural Clinical Trials – www .NaturalClinicalTrials .org

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj

Current SOP Project: CAPA: Correction and Prevention Analysis
Do you need a CAPA SOP? See attached outline, below.

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) with “Unsubscribe” in the subject line.


Corrective and Preventive Action
CAPA notes

Main Headings of the CAPA SOP

Discovery of the Deviation
Documentation of the Event
Immediate Corrective Action
Investigation of the Primary Cause
Causal Analysis
Corrective Action
Effectiveness Evaluation

1. How to Discover a Deviation from SOPs

a. By External and Internal Audits
b. By Observation by Staff
    While performing a task
    While inspecting or testing
    While process and equipment monitoring
    While reviewing records

c. By Review of Change Controls

d. From Complaints, adverse events, product returns or recalls

e. Due to notification by a customer or client

2. Documenting the Deviation

What was the deviation
Who was involved
When did event occur
Where did event occur
How was deviation discovered
How frequently does the process occur
What immediate corrective action taken

3. Immediate Corrective Action Taken

a. Products: isolated, sampled, discarded

b. Equipment: removed and replaced

c. Processes: suspend process

4. Investigation

a. Circumstances at time of deviation

  How and why deviation occurred
  Determine if other products, processes involved
  Determine staff involved
  Gather data to develop corrective action

b. Interview: staff, customers, suppliers

c. Review: policies, procedures, forms

d. Review: Training, equipment, soft/hardware

5. Primary Cause Analysis

To discover the primary (root) cause
To reduce risks or recurrence
To improve operations: policies, procedures, forms
To maintain compliance with SOPs and QC

a. Conclusions should be based on systematic review of documented evidence.

b. Problems may have more than one primary cause. All known casual links need
to be established. Performance improvement recommendations should be based
on the primary cause analysis.

b. PCA answers:

How did the deviation occur?
Why did the deviation occur?

c. PCA also seeks to understand:
Physical, organizational or process factors in place to detect deviations
[where were the factors; what was their level of effectiveness; what
factors failed]

6. Corrective Action

a. A plan of action that will eliminate or reduce the primary cause of the
deviation, failure or breakdown.
Implementation through:

b. SOPs
Process changes (including materials and procedures)
Training and retraining
Use of automation or new equipment

c. Corrective action is limited to changing the primary cause through the
above noted implementation strategies.

7. Effectiveness Evaluation

Effectiveness evaluation aims at documenting that the corrective action was
implemented as planned and that the corrective action is effective in the
reduction or prevention of recurring deviation, failure or breakdown.

a. The EE verifies:

That corrective action was properly implemented
The data source for the EE
When the EE was performed
Success criteria
Whether the CA met the success criteria

b. Document omissions, corrections, completion and recurrence of original deviation

c. EE is the responsibility of Operations Management to be accomplished within
a reasonable period after the implementation of the CA.

d. QA should perform a post CA audit to determine overall effectiveness.
e. If the EE shows a failure to correct the deviation, the CAPA process must
be restarted with a new Primary Cause Analysis.

f. Consider:

i. Possible undiscovered other or multiple (independent) primary causes
ii. Significant undiscovered contributing factors


Define deviation, failure or breakdown
Gather data
Identify causal relationships
Identify which causes if changed with prevent recurrence
Identify effective potential solutions to prevent recurrence
Implement Corrective Action
Evaluate Effectiveness

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