(Silver Spring, MD) -- Is your company prepared for the day a Food and Drug Administration (FDA) inspector shows up at your doorstep with clipboard in hand and a bevy of questions about your facility and how it's operated? Are you aware of the current federal laws dictating what authority an inspector has when an inspection of your facility is conducted? If your answer is “No” to either of these questions, or a hesitant “Yes,” you might want to spend two hours to gain a better understanding of your rights and obligations before you receive that knock at your door from an FDA inspector.
To assist our industry in gaining a better understanding of its rights and obligations when the FDA conducts an inspection of a facility in which dietary supplements or ingredients are manufactured, processed, packed or held, AHPA will be presenting a tele-seminar on How to Conduct an FDA Inspection. In approximately two hours, participants will be presented with the following:
An overview of FDA’s inspection authority, which derives from both the Federal Food, Drug and Cosmetic Act and the Bioterrorism Act
Suggestions on the steps that a firm should take in advance to be prepared for an FDA inspection
Guidance on what should be expected during an inspection by FDA personnel
Observational findings that follow an inspection and the need to maintain a thorough internal record of each inspection
FDA’s inspection authority and procedures are different for each of the various classes of consumer goods over which that agency holds jurisdiction. Because dietary supplements are defined as foods, FDA inspects dietary supplement facilities in accordance with their policies for food facilities, and to ensure that the facility is operating in accordance with current good manufacturing practices (cGMPs) for manufacturing, packing and holding human food. The regulation that applies to cGMPs for food can be found at Title 21 of the Code of Federal Regulations, Section 110 (21 CFR 110). FDA published a proposed rule for cGMPs for dietary supplements and dietary ingredients on March 13, 2003, which will replace 21 CFR 110 upon its final adoption. This tele-seminar is based on FDA’s rules for inspecting conventional foods, and is therefore relevant to most companies that are engaged exclusively in trade in dietary supplements and their ingredients.
Because federal laws and regulations can be amended from time to time, it is vital to be aware of any such amendments, and to understand the current status of all relevant rules. This tele-seminar will not be a substitute for the federal law and regulations that apply to inspections of facilities that manufacture, pack or hold dietary supplements or dietary ingredients. Instead, it should be viewed as a supplementary guide to the law and regulations. Information provided will not be intended to replace or supersede instructions, guidelines or regulations issued by FDA.
A convenient and cost-effective way to explore issues, gain insight, and enhance knowledge, the tele-seminar is a live telephone conference call. To facilitate freedom to raise difficult issues, participants may forward questions, via email to an AHPA staff member, which will be read aloud in an anonymous fashion during the Q&A session. A transcript of the seminar will be available for purchase, which frees you from taking notes, and provides a valuable resource document to develop your own in-house FDA inspection standard operating procedure. A Certificate of Completion, an important addition to cGMP compliance training and personnel files, will also be made available for a small fee.
Scheduled to begin at 2 pm ET / 11 am PT on August 30 and September 8, 2005, each seminar will be limited to just 30 call lines, but as many staff members as you wish may listen to your speaker phone. It would typically cost you an exorbitant amount to hire an attorney or consultant to conduct GMP training, but AHPA is offering the same training for a fraction of the cost. The seminar costs $110 per connection for AHPA member companies, and $195 per connection for non-member companies. Optional transcripts cost an additional $10, and any Certificate of Completion beyond the first certificate will cost an additional $10 each.
Register by downloading an online form (http://www.ahpa.org/05_0800_AHPA_FDAInspection_Teleseminar.pdf) and fax to 301-588-1174, Attention of Natasha Hall, JD. Once registered, you will receive an email confirmation with the phone number to call.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org