The Natural Products Association (NPA) has expanded the popular Good Manufacturing Practices (GMP) training seminar, “What You Need to Know: How the FDA GMP Rule for Dietary Supplements Applies to You.” NPA now offers two full days of comprehensive training, consisting of four half-day sessions. The first opportunity to attend this seminar will be at Expo West on March 7 to 8 in Anaheim, Calif. NPA members save up to $355 off the two-day seminar registration rate. Find out more and register at NPAinfo.org/GMP.
NPA expects that 2013 will bring a stricter level of GMP enforcement by the Food and Drug Administration (FDA). This course is vital for anyone whose job requires an understanding of the GMP rule for dietary supplements, including senior management, regulatory affairs staff and QA/QC, production and laboratory personnel.
The best way to prepare for a likely 2013 FDA inspection is to attend an NPA GMP seminar. Choose to attend the full two-day seminar or, new for 2013, attend one or more of the half-day sessions separately. Each half-day session includes practical application activities.
Morning Session: Quality Control, Documentation & Change Control – covers business models, quality control, GMP documentation (SOPs, records and documented rationale for each subpart), and change control
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, and new FSMA information
Morning Session: Manufacturing Operations, Deviations and Material Reviews – covers master manufacturing records and batch production records, manufacturing operations, deviations and investigations, and material reviews
Afternoon Session: Maintaining Compliance and Update on FDA Inspections – covers tips on monitoring and maintaining compliance, using mock recalls, internal audit and investigation trend data to ensure compliance, when to call in an expert, the nuts and bolts of an FDA inspection, review of FDA inspectional activities, and how to respond to FDA 483s to avoid escalating enforcement action
As the first in the industry to offer dietary supplement GMP education, NPA has had more than 1,000 participants from more than 600 companies attending these GMP education sessions since 1999. NPA’s presenters are industry experts who offer the unique perspective of consulting for the industry as well as working in the industry to develop and implement effective quality systems.
The seminar presenters, Cindy Beehner, president of QSD Consulting, and Aaron Secrist, quality and regulatory manager at NOW Foods, have worked with hundreds of firms of all sizes. They have more than 40 years combined experience addressing FDA regulations, especially in the area of GMP and dietary supplements.
NPA’s 2013 GMP seminars will be held in conjunction with the following trade shows:
- Expo West, Anaheim, Calif., March 7-8
- Expo East, Baltimore, Md., September 25-16
- Located close to an industry supply show, Las Vegas, November 11-12
NPA also launched a GMP certification program in 1999, the first third-party GMP certification program for the manufacturing of dietary supplements and ingredients. More than 70 companies have achieved certification. For certification details and seminar registration, visit NPAinfo.org/GMP.