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The Experts in FDA and USDA Regulatory Matters

EAS Consulting Group is a leading provider of regulatory compliance solutions to industries regulated by FDA, USDA, and supporting agencies. Our team of consultants provide expert guidance for all of your regulatory requirements.

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EAS Food Industry Services

Food

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dietary supplements

Dietary Supplements

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pharmaceuticals

Pharmaceuticals

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EAS Medical Devices Services

Medical Devices

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EAS Tobacco Services

Tobacco

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cosmetics

Cosmetics

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Cannabis

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Seminars

21 CFR Part 11 (Electronic Records & Signatures) Compliance for Computer Systems Regulated by FDA

21 CFR Part 11 (Electronic Records & Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated, or “GxP” computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in 1997 and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic, or system of record.

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Webinars

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On Demand Webinars

Medical Device QMSR (ISO 13485)

Medical Device QMSR (ISO 13485)

This webinar will highlight the major changes to the regulations and give an overview of how the regulations have updated. Also covered are implementation of the new final rule, and what steps to take to best prepare for the start of enforcement by the FDA.

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