EAS COVID-19 Reopening Strategies - Are you Prepared?

ALEXANDRIA, Va., June 2, 2020 /PRNewswire/ -- EAS Consulting Group: As states begin to ease restrictions, the dawn of a new sense of normalcy is on the horizon. For Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) regulated industries, that new normal requires immense planning and preparation before returning to pre-pandemic operations.

• Is your restaurant or retail facility, staff and management ready for the new regulatory and customer-expected norms?
• Have you updated your facility and staff hygiene operations, and were Good Manufacturing Practices (GMPs) change controls incorporated?
• Employees are returning to the line, are they being retrained to safely operate their equipment?
• Have you completed a "deep cleaning" and swabbing of key areas of the facility, equipment and "high touch" surfaces to verify your cleaning has been effective?
• Does your current outside testing laboratory have the "right" capabilities to address the post-COVID-19 requirements?
• Are all equipment calibrations current and has any equipment that has been relocated also been requalified?
• Do all of your employees understand and comply with sanitation and hygiene standards?
• Is it time for refresher or annual GMP training?
• Are you in need of new overseas ingredient suppliers and have they been vetted against GMP requirements, the Foreign Supplier Verification Program (FSVP) Rule, and US FDA Preventive Control regulations?
• As your supplement facility returns to work, how will you notify FDA of stored Serious Adverse Events (SAEs)?
• Did you register your facility and list your drug products as you began producing hand sanitizers?
• If you were manufacturing sanitizers and face masks during the emergency period, are you prepared to operate in accordance with the full set of GMP requirements?

There are numerous challenges to reopening, regrouping and ensuring you compliance with federal and state regulations are in order. EAS Consulting Group along with our parent organization, Certified Laboratories, offers remote assistance for all these challenges and more. Our over 150 consultants are former senior FDA, USDA, OSHA, EPA and CBP officials and industry executives who offer unparalleled expertise as well as wide-ranging ISO 17025 laboratory testing capabilities.  As such, EAS can assist you with how to best address and weather unexpected operational changes, whether they are being driven by the market, government regulations or COVID-19, in a timely, ethical and cost-efficient manner.

Contact EAS today to understand your regulatory requirements and learn how we can be of assistance.

About EAS Consulting Group:

EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD.

Through our alignment with Certified Laboratories, a leading full-service food testing laboratory servicing the food industry since 1926 (certified-laboratories.com), Labstat, a best in class tobacco, nicotine and vape safety laboratory (labstat.com) and Labs-Mart, a dietary supplement, vitamin, and healthy products laboratory, (labs-mart.com), EAS can assist you with your regulatory requirements and challenges, while offering a more robust scope of testing services to meet your organization's sophisticated needs.

From strategic product development, toxicology and microbiology assistance, including preparation of technical submissions such as GRAS, Food Additive Petitions, DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services, due diligence assessments, or support after receipt of a FDA form 483 or Warning Letter, including market withdrawals, recalls and improvement plans with follow-on mock-FDA inspection audits, EAS offers the detailed knowledge and experience your company requires to ensure accurate and timely assistance. With our vast expertise in FDA's policies and enforcement, EAS is the proven choice for assistance with FDA, product testing and other regulatory solutions. easconsultinggroup.com

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