TraceGains Webinar Helps Food Leaders Prepare and Manage an FDA Audit
Westminster, CO -- (SBWIRE) -- 08/27/2013 -- TraceGains is hosting a webinar entitled, “Preparing for and Managing an FDA Audit,” on Thursday, September 12, 2013 12:00-1:00 pm EST. The webinar will help food manufacturers prepare and manage when the FDA shows up at their facility. This webinar will provide an overview of the FDA’s authority to conduct inspections, pre-inspection planning, inspection day logistics, and post-inspection follow-up.
The webinar will address the laws and regulations that govern FDA inspections, personnel and their inspection-related duties, as well as how to identify and organize company records likely to be relevant during an inspection. The webinar will help leaders prepare for inspection day procedures, including: interacting with FDA representatives; addressing FDA’s questions; responding to requests for documents and samples; protecting the company’s proprietary information; and closing out the inspection. Additionally, post-inspection issues will be covered including: responding to the FDA’s Form 483 and Warning Letter (if applicable), reviewing the FDA’s Establishment Inspection Report.
Antonio Gallegos will co-present the webinar. Gallegos provides regulatory compliance, dispute resolution and trial strategies for the food, nutrition, medical device, pharmaceutical and sports industries. He represents businesses and individuals in lawsuits, arbitrations, mediations, government investigations and regulatory enforcement actions. Gallegos also advises on compliance with regulations administered by the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), Department of Agriculture (USDA), and similar state-level agencies.
Antonio’s pro bono and community service include co-founding a non-profit program to help small businesses understand their legal issues. He also advocates for the interests of poor and minority children in the public school system, and provides risk management and other legal counsel to youth sports leagues.
Space is limited so early registration is encouraged. Register at: https://www3.gotomeeting.com/register/270817198.
TraceGains (http://www.tracegains.com) is for quality, purchasing, product development, and other departments, that are burdened with manually managing suppliers and documents. Supplier documentation storage, whether in file cabinets or in digital formats, may satisfy regulatory retention requirements, but does little to systematically unlock the wealth of business, compliance, and regulatory information they contain and you require on a daily basis to operate successfully.
By automatically analyzing and scorecarding supplier-provided documentation as it is received—such as certificates of analysis, qualification questionnaires, audit documents and their results, certifications (Kosher, Organic, etc.), insurance certificates, allergen questionnaires, and other import requirements (COOL, C-TPAT, FSMA, GFSI), among others—TraceGains helps food and nutraceutical manufacturers and ingredient processors automate document management, meet regulatory and industry compliance requirements, identify best and worst suppliers, source better with less risk, automatically raise product quality, and painlessly perform or participate in audits, all without needing to involve the IT department to help with complex technology.
Some of the food industry categories which have observed significant benefits using TraceGains include baking mixes, alcoholic and non-alcoholic beverages, snack foods, confectionery, dairy, salad dressings, herbs & seasonings, flavors, dips, glazes & marinades, cheese processing and manufacturing, frozen foods, breakfast cereals, dietary supplements, Meals Ready to Eat (MREs), convenience foods, and restaurant chains.
TraceGains customers experience on average a 56% reduction in out-of-spec lot receipts, and a 20% reduction in attribute variability, resulting in enhanced continuous improvement, better performing ingredient and raw material inventory, improved cash flow, and long-term brand protection. Follow TraceGains on Twitter at @tracegains.
Director of Marketing
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