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Tuesday, Oct. 21 from 8am to 5pm
Wednesday, Oct. 22 from 8am to Noon
Presented by
 In response to the U.S. Food and Drug Administration’s
(FDA) good manufacturing practices (GMP) rule published on
June 25, 2007, the Natural Products Association is offering
an one and half day educational seminar event to discuss the
impact and provisions of the final rule. This important
regulation establishes new mandatory requirements for
dietary supplement manufacturers and dietary supplement
distributors. Learn about what is expected and the
consequences of non-compliance.
This course is designed for companies with a good
understanding of current industry GMPs and will be relevant
for anyone whose job responsibility requires a comprehensive
understanding of the FDA GMP rule for dietary supplements,
including management, and regulatory affairs, QA/QC,
production and laboratory personnel.
Seminar presenters include:
Carl Reynolds, Vice President, EAS consulting
Cindy Beehner, President, Quality Design Systems
Aaron Secrist, Director of Quality, Nature’s Way
Natural Products Association Staff
Seminar presenters have over 75 years combined experience
in addressing FDA regulations, especially in the area of
good manufacturing practices and dietary supplements. Ms.
Beehner and Mr. Reynolds have first-hand experience working
with industry to meet the challenges of compliance to the
laws and regulations related to dietary ingredients and
dietary supplements and Mr. Secrist will present an industry
insider’s perspective on meeting the requirements of the new
rule.
Agenda:
- Comprehensive discussion of specific FDA GMP
requirements including establishing and confirming
specifications, QC personnel responsibilities,
laboratory operations, scientifically valid analytical
methods, raw materials and finished product testing
requirements, and change control
- Developing GMP-compliant SOPs, master manufacturing
and batch production records, and other required
documentation
- Working with your suppliers and other vendors to
ensure quality and consistency in meeting GMP compliance
- Third-party certification
- How to handle visits from the FDA
- Tips on getting started incorporating new FDA GMP
requirements within your company’s current GMP systems
- Opportunity for technical question and answer
discussion with industry GMP experts
- Group activity regarding establishing regulatory
specifications
Registration:
NATURAL PRODUCTS ASSOCIATION Member* $695
Non-NATURAL PRODUCTS ASSOCIATION Member* $895
10% discount available to registrants from the same
company
To Register:
- Click here to download the Registration
Form
- Call (800) 966-6632 ext. 243
- Email
vwhitsitt@naturalproductsassoc.org
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