TraceGains Inc.

Recent TraceGains Webinar Featured Best Practices to Manage an FDA Audit

Recent TraceGains Webinar Featured Best Practices to Manage an FDA Audit


Westminster, CO -- (SBWIRE) -- 09/23/2013 -- TraceGains, Inc. recently hosted a webinar with Antonio Gallegos, Attorney at Greenberg Traurig, LLP. Gallegos provides regulatory compliance, dispute resolution and trial strategies for the food, nutrition, medical device, pharmaceutical and sports industries. Gallegos discussed 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.

To view the webinar in its entirety, click this link:

The webinar helped 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 were covered including: responding to the FDA’s Form 483 and Warning Letter (if applicable), reviewing the FDA’s Establishment Inspection Report.

TraceGains ( delivers full-service supplier, compliance, and regulatory document management solutions, including FSMA and GFSI. The TraceGains solution is for quality, purchasing, product development, and other departments, that are burdened with manually managing suppliers and documents. Unlike manual, ERP, or traditional document systems, TraceGains extracts data from documents and automatically takes action.

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.

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.

TraceGains, Inc.
Jennifer Brusco
Marketing Strategist