The American Herbal Products Association proudly presents the latest in its series of industry educating tele-seminars on dietary supplement Good Manufacturing Practices (GMP) compliance - Meeting Specifications: Establishing Identity & Vendor Qualification - to be held on June 17, 2010 from 1-3pm ET. With the regulations effective for all dietary supplement companies as of June 25, 2010, this seminar will be of vital importance and provide valuable information to keep your company in compliance with federal regulations.
Key topics that will be covered in this seminar:
· What is required under the GMP regulation - Tony Young, Esq. - Partner, Kleinfeld, Kaplan & Becker
· The basics of the GMP and establishing identity & vendor qualification
· Specific advice for small businesses
· Contracts & vendor agreements
§ What to do when materials are out of specification (OOS)
· Identity Testing - Steven Dentali, Ph.D. - Chief Science Officer, AHPA
· What constitutes a scientifically valid method and examples of methods that are "fit for purpose"
· The importance of specifications
· OOS procedures
· General information about the different types of methods for identity testing
· Qualifying a 3rd Party Vendor to Conduct Identity Testing - Margaret King, Senior Director QA/QC, Metagenics
· Specifications and identity testing using 3rd party vendors
· How to determine the expertise of a 3rd party laboratory
§ Why specific expertise is important
§ Appropriate accreditation & certification
§ Contractual agreements
· Discussions with suppliers
· Agreements on appropriate methods
· Internal personnel skills necessary to assess test results & OOS results
· Supplier/Vendor Qualification - Angie Kwong, Quality Manager, Traditional Medicinals
· Vendor qualification & re-qualification
· When, how, and how often?
§ OOS - when does it result in disqualification, probation and how do you re-qualify?
· International Vendor Qualification
· How to ensure US regulations are accounted for
· Notification of changes in sources
§ SIDI Working Group Efforts
· COA Guidelines & Templates; DIDS
· Vendor Qualification From the Raw Material Suppliers Viewpoint - Rupa Das, VP Global Quality & Compliance, BI Nutraceuticals
· Examples of mistakes made in vendor qualification
· Third party audit experiences
Who Should Attend this Seminar?
If your company manufactures dietary supplements you will want to attend this seminar. Even if you already have implemented related GMP programs into your business model or units, you will likely glean valuable new ideas that you can use to hone in on these specific topics. QA/QC, laboratory, regulatory & compliance, and other key personnel will find this information of particular value.
More information, including secure, online registration, is available at www.ahpa.org or contact AHPA.
Other AHPA GMP Compliance Titles
Since the FDA released 21 CFR 111 (the dietary supplement GMP) Final Rule in 2007, AHPA has been providing industry with guidance and education on GMP compliance. Below is a sample of currently available titles (a complete list can be found in the AHPA online bookstore or contact AHPA for details):
· Good Documentation Practices Manual & Example/SOP Templates
· FDA Inspection Guidance & SOP
· cGMP Compliance Series Seminars:
· Record Keeping, Documentation & How to Write SOPs
· Setting & Meeting Specifications for Contaminants in Finished Products
· Shelf Life Statements on Dietary Supplement Labels