The Natural Products Association announces a new webinar series, “Regulatory Trainings Straight from Your Desk,” beginning August 22 with an education session about good manufacturing practices for own-label distributors, re-packagers and re-labelers. Attendees will learn their responsibilities to ensure what GMP requirements must be met internally and what may be shared or outsourced. Expert speakers include Dr. Daniel Fabricant, director of the FDA Division of Dietary Supplement Programs, and Cindy Beehner, president of QSD Consulting. Sign up at www.NPAinfo.org/GMPWebinar.
“We at NPA are proud to continue our leadership role in providing quality education for the dietary supplement industry. It’s not easy for everyone to commit to attending a seminar, so our webinar series allows more flexibility in your schedule while still providing the high level of regulatory instruction the industry has come to expect from NPA. With the FDA’s increasing number of facility inspections, combined with recent scrutiny of supplement manufacturing practices, it’s vitally important that the industry do everything possible to come into compliance with the GMP Rule,” said Cara Welch, Ph.D., senior vice president of scientific and regulatory affairs for NPA.
The August 22 webinar will cover:
- Setting specifications and verification testing for own-label products
- The required product-specific GMP documentation: master manufacturing records and batch production records
- The review, approval, release and distribution procedures for own-label products
- Establishing a compliant quality control system for an own-label distributor operations
- How to qualify contract manufacturer and any other contract facilities used for GMP-related operations
- The elements of a strong GMP agreement between an own-label distributor and contract manufacturer
- Handling complaints for own-label products
The following NPA webinar about product labeling will be held in two parts on October 16 and 18 with leading industry labeling expert Richard Flora, president of R. Flora & Associates. Participants will learn how to avoid a warning letter for labeling issues or product claims, and how to correctly use claims to educate customers about products without making them “unapproved new drugs.” Other highlights will include:
October 16 session
- Mandatory elements that must be on the product label
- Labeling basics such as font sizes and placement requirements
- Information that must or may appear in the Supplement Facts box and how it must be organized
- The differences between dietary ingredients, source ingredients, other ingredients, and the requirements for each
October 18 session
- What claims are allowed and how claims are properly worded
- Supplement Facts box claims
- Differences between the various types of claims: structure/function statements, nutrient claims, health claims and more
- Why some claims are considered drug claims by regulators
NPA members get exclusive registration discounts. CD copies also will be available for sale. Additional webinars will be announced as they are scheduled. Find out more at www.NPAinfo.org/GMPWebinar.
NPA’s next in-person GMP seminar will be at Expo East in Baltimore on September 19-20.