NPA Presents Two (2) Education Events

NPA Presents Two (2) Education Events:
What You Need to Know Prior to an
FDA Dietary Supplement cGMP Inspection
(This is a one and half day course)
and
Agency Insights: Claims and Other Compliance Issues
(This is a half day course)
The WHO WHAT WHERE WHEN WHY & HOW of Dietary Supplement cGMPs - 21 CFR 111 has been in the
dietary supplement regulatory forefront for the last three years and it will remain there through 2014. In FY
2013, FDA conducted over 500 inspections of dietary supplement companies. Unfortunately, approximately
70 percent of these inspections resulted in either FDA 483 observations or warning letters, or worse.
NPA’s comprehensive GMP training course covers some of the more complex GMP issues and provides tips
for compliance. Industry expert presenters Cindy Beehner, President of QSD Consulting, and Aaron Secrist,
NOW Foods’ Director of Quality and R&D, will present in-depth discussion of the cGMP requirements with an
emphasis on those areas that are continuing to show up in warning letters and includes activities and case
studies to demonstrate the practical application of the material.
Hear from the industry’s King of Natural, Dr. Daniel Fabricant, NPA’s CEO/Executive Director. Dr. Fabricant
will stop by to share a few of his biggest takeaways from his more than three years serving as the director of
the U.S. Food and Drug Administration's (FDA) division of dietary supplements, and his insight into what's in
store for the industry and how it can get where it needs to go.
The WHO WHAT WHERE WHEN WHY & HOW of Dietary Supplement Labels, Label Claims and FDA Inspections
–Did you know that before FDA steps foot in your facility, they have reviewed your product labels, your
websites and social media? NPA’s own FDA experts will discuss how your label and label claims play into the
overall regulation of supplements and are an intrinsic element of FDA inspections. This session will cover
the role of product claims and labels, warning letter triggers, inspection metrics, what FDA Investigators
look at, questions you should be prepared to answer, and more. The seminar includes examples of recent
FDA cases and a generous question and answer period.
Hear from NPA’s premier FDA experts Dr. Daniel Fabricant, NPA’s CEO/Executive Director and Dr. Corey Hilmas.
Recently christened The King of Naturals by Time Magazine, Dr. Fabricant returns to NPA after his more than three
years serving as the director of the U.S. Food and Drug Administration's (FDA) division of dietary supplements. Dr.
Corey Hilmas, NPA’s Senior Vice President of Scientific and Regulatory Affairs, joined NPA in June after having
served as chief of the Dietary Supplement Regulation Implementation Branch within the Division of Dietary
Supplement Programs at the FDA for more than two years
NPA is the leader in dietary supplement GMPs and regulatory education, launching the industry's first GMP
third-party certification program in 1999 and has since provided the highest quality of dietary supplement
GMP education to more than 1,000 attendees over 15 years.
These courses are relevant and valuable for anyone whose job requires an understanding of the FDA labeling
and GMP rules for dietary supplements, including senior management and regulatory affairs, QA/QC,
production, and laboratory personnel.
REGISTRATION FORM:
NPA Regulatory Seminars – Las Vegas, NV
The GMP seminar is a 12-hour, 1 & ½ day event: consisting of 3 half-day sessions – now you can
attend the full seminar, or attend one or more of the half-day sessions individually.
·
Day One Morning Session: Quality Control, Documentation & Change Control – covers business models,
Quality Control, GMP documentation (SOPs, Records & Documented Rationale for each subpart), Change
Control & Master Manufacturing and Batch Control Records
·
Day One Afternoon Session: Specifications and Verification Testing – in depth coverage of establishing
specifications and verification testing, methods, data integrity, where to find information, qualifying vendors &
·
COAs, GMP agreements,
Day Two Morning Session: Production and Process controls, Deviations and Material Reviews & Putting It All
Together–covers manufacturing operations, laboratory operations, deviations & rework, investigations and
material reviews and an in-depth example how a compliant GMP-system works
The Agency Insights: Claims and Other Compliance Issues seminar is a 4-hour afternoon session:
·
Hear from NPA’s FDA experts about how your label and claims play into the overall regulation of supplements
and are an intrinsic element of FDA inspections. This session will cover the role of product claims and labels,
warning letter triggers, inspection metrics, what FDA Investigators look at, questions you should be prepared
to answer, and more.
Las Vegas, NV: October 6th & 7th
(Morning sessions run 8 a.m. – 12:00 p.m. / Afternoon sessions run 1:00 – 5:00 p.m.)
Name(s) & Title(s)
Company
Address
City/State/Zip
Phone
Ext.
Fax:
Email (receipt & confirmation sent by email)
Registrations must be accompanied by check or credit card information.
·
·
·
All registrants will receive a confirmation notice five (5) business days before the seminar.
Registration substitutions may be made at any time.
All requests for refunds are subject to a $100 processing fee. Refunds will be issued if notification is
postmarked, emailed or faxed five (5) business days prior to the day of the seminar.
·
Pre-registration deadline is five business days prior to the day of the seminar. Those who do not pre-register
can register onsite, space permitting, for an additional fee of $100 per attendee.
·
NPA reserves the right to make program changes as necessary or to cancel the program if minimum
enrollment has not been reached or events occur beyond the reasonable control of the NPA.
If paying by check: Please send completed registration form with payment to: Natural Products Association,
P.O. Box 347136, Pittsburgh, PA 15251-4136.
* Registrants who attend both the NPA’s GMP seminar and the Agency Insights seminar scheduled in Las Vegas will
receive a $100 discount on both seminars. Call (800) 966-6632 ext. 243 for more information.
REGISTRATION FORM:
NPA Regulatory Seminars – Las Vegas, NV
If paying by credit card, please fax your registration to (202) 223-0250 or email to [email protected].
Credit Card #
CID Number (usually on back of card)
Expiration Date
Authorized Signature
Credit Card Billing Address
FEES (10% discount on seminars for multiple registrants from the same company)
1B
GMP Seminar* - Monday & Tuesday, October 6 & 7 (1 & ½ day event)
□ NPA Member: $995 for 1 attendee or $895.50 per attendee for multiple registrants
□
$
Non-NPA Member: $1350 for one attendee or $1215 per attendee for multiple registrants
Individual Session(s) – please select session(s) below:
□
NPA Member: $400 per individual session
□
Non-NPA Member: $500 per individual session
□
□
□
Day One – A.M. Session: Quality Control, Documentation & Change Control
$
$
$
Day One – P.M. Session: Specifications and Verification Testing
Day Two – A.M. Session: Manufacturing Operations, Deviations and Material Reviews
Agency Insights: Claims and Other Compliance Issues* - Tuesday, October 7 @ 1:00 – 4:00 p.m.
□ NPA Member: $595 for 1 attendee or $535.50 per attendee for multiple registrants
$
□
Non-NPA Member: $995 for one attendee or $895.50 per attendee for multiple registrants
TOTAL AMOUNT
$
$
Questions: Contact Vicki Whitsitt at (202) 503-1961 or [email protected] for more
information
* Registrants who attend both the NPA’s GMP seminar and the Agency Insights seminar scheduled in Las Vegas will
receive a $100 discount on both seminars. Call (800) 966-6632 ext. 243 for more information.

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