EduQuest, Inc.

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Martin Heavner has been writing and developing learning content for regulated industry in the U.S. and overseas for more than 30 years. During this time he has developed curricula for more than 220 training courses delivered both in classroom settings and through self-study programs, e-learning technologies and multi-media webinars. Martin Heavner works with Subject Matter Experts (SMEs) to educate adults about complex regulatory requirements and develop practical training materials to help them comply with FDA, EMA, ICH, ISO, EPA, OSHA and DOE rules and guidance. At EduQuest, Martin Heavner manages corporate communications, develops new information products and content, and assists t...

fda compliance eduquest quality quality systems validation qsr martin browning regulatory compliance quality management audits inspections capa part 11 data integrity ivt electronic records supplier management outsourcing supply chain suppliers training management responsibility consent decree enforcement denise dion internal audit objective evidence verification correction recall medical device part 806 removal quality system computer systems variance nonconformance medical device concession iso deviation inspection device

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EduQuest, Inc.

Présentations

Management Responsibility for FDA Quality Systems

FDA Requirements for Supplier Management: A Primer from EduQuest

FDA Data Integrity: Misconceptions of 21 CFR Part 11

Documents

Medical Device Concessions - EduQuest Advisory

9 Common Validation Errors EduQuest Advisory

Hot Potato Of Responsibility Edu Quest Advisory

EduQuest Advisory 4 Pillars Of Qsr Compliance

21 cfr part 806 Process Flow for Device Recalls

What is Objective Evidence? - EduQuest FDA Compliance Advisory