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
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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
ralph.fucetola@usa.net 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
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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.]
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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...”
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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.
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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: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84
[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).
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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) usa.net with “Unsubscribe” in the subject line.
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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
CAPA SUMMARY
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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