The Training Program
Three Step Training

I provide you with the formats needed to meet the new standards and guide you to “tweak” and implement them.  

Once your papers are in order, I conduct in-depth training webinars for your Company and Certify your compliance for FDA SOP/GMP regulations and training.

The Full Certification Program involves the following:

[1] ESTABLISH – I work with your CEO to to customize my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company

[2] SET-UP – I work with your company for proper and precise implementation of the SOPs, including production logs, Product Claim Language control, definition & substantiation, and help you prepare the FDA required S&F Claims Notice.

[3] TRAINING - It's not enough to have procedures. The FDA says: train your team and prove they are qualified.

-- Presenting the SOPs to your staff - 2 Sessions.
-- Training the staff in the SOPs - 2 Sessions.
-- Special Record Keeping Webinar - 1 Session
 -- Certifying the staff in the SOPs - Online Test.

4. Bonus Training

See: PEL Webinar Training Program
Says FDA - "The dietary supplement market has changed significantly since the passage of DSHEA [Dietary supplement Health and Education Act of 1994]. The industry itself has grown exponentially and so has the number of Americans buying these products. Access to dietary supplements has also changed. Today a wide range of dietary supplements can be purchased in supermarkets or through the Internet...

"This final rule establishes industry wide standards requiring that dietary supplements are manufactured consistently as to their identity, purity, strength, and composition. Accordingly, consumers should have increased confidence in the dietary supplement products they purchase.

"The regulation includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. It also includes requirements for maintaining records and for handling consumer complaints related to dietary supplement products..."

2007 cGMP Webinar - Janice Oliver, Deputy Director
Center for Food Safety and Applied Nutrition


Sher Komisar: 914-966-8053
[email protected]
Program Investment Cost: Click Here
A Regulatory Compliance Network™ Program
TO ORDER YOUR ACCESS TO THE CERTIFICATION PROGRAM, CLICK HERE
Private Webinar Site Training Video
PEL
   
PRACTICAL, ETHICAL AND LAWFUL
ARCHIVED WEBINARS

The SOP Certification webinar training is supplemented by my archived webinar programs designed around issues of interest to people in the dietary supplement industry, natural products and Advanced Health Care [CAM] practitioners.

Some of the topics my archived webinars include are:
  
- Lawful Natural Product Copy Writing
- Dietary Supplements in Physician Practice
- CAM Cautions: Alternative Practices
- The Ministry and Healing Arts