Quality Systems Compliance, LLC
GAP Analysis Mock Inspection in Ohio

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Quality Systems Compliance, LLC and Mark Durivage specialize in FDA, ISO and Quality Systems auditing, training and consulting for the medical and auto industries, and organizations involved with tissue and food.

We provide GAP Analysis Mock Inspection in Ohio, across the U.S., and internationally.

Please visit our Home page to begin learning more about Mock Inspection and other services provided by Quality Systems Compliance, LLC. We look forward to helping your organization meet your GAP Analysis goals in a quick, cost-effective manner.

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Professional development courses, online training and online certification for regulated and audited industries following ISO and FDA guidelines
Online Source for Same-day ISO, FDA, Quality and Compliance Courses

Online Quality, Compliance & Professional Development Courses Looking for online training, professional development or certification [...]

06
Oct
ISO 9001-2015 and ISO 13485-2016 Certification
Quality Systems Compliance, LLC Now Certified for ISO 9001:2015 and ISO 13485:2016

We’re pleased to announce Quality Systems Compliance, LLC has recently been awarded certifications for maintaining [...]

10
Nov
Preparing for an ISO Audit Mark Durivage
Preparing for an ISO Audit

Preparing for an ISO certification, surveillance, or recertification audit can be daunting stress filled task, [...]

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Jan
certificate of Quality Systems Complaince Top 10 Medical Device Consulting Company 2019
Ranked on Top 10 List Medical Device Consulting Companies in 2019

Quality Systems Compliance named one of the Top Ten Medical Device Consulting Companies in 2019 [...]

19
Nov
How To Prepare For An FDA Inspection
How To Prepare For An FDA Inspection

How To Prepare For An FDA Inspection By Mark Durivage, Quality Systems Compliance LLC Every [...]

30
Jul
A Military Tool For Pharma Vulnerability Assessment
A Military Tool For Pharma Vulnerability Assessment — The CARVER + Shock Technique

By Mark Durivage, Quality Systems Compliance LLC Following the terror attacks of Sept. 11, 2001, [...]

13
Jun
FDA Proposes Program To Establish Voluntary Pharma Quality Standards
FDA Proposes Program To Establish Voluntary Pharma Quality Standards

By Mark Durivage, Quality Systems Compliance LLC The FDA’s Center for Drug Evaluation and Research [...]

14
May
Quality professional reviewing compliance documents after an FDA inspection
What Should You Do After An FDA Inspection?

What Should You Do After An FDA Inspection? By Mark Durivage, Quality Systems Compliance LLC [...]

11
Apr