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BIOGRAPHY

Mark Allen Durivage

Managing Principal Consulatant, Quality Systems Compliance LLC, Lambertville, MI, USA

Mark Allen Durivage has worked as a practitioner, educator, and consultant. He is Managing Principal Consultant at Quality Systems Compliance LLC located in Lambertville, MI. His consulting practice includes a diverse clientele serving clients globally. Durivage has been elected to Fellowships in ASQ and SRE. Durivage holds several professional certifications including CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS.

Durivage has written several books available through ASQ Quality Press including Practical Engineering, Process, and Reliability Statistics, Practical Attribute and Variable Measurement Systems Analysis (MSA), and Practical Design of Experiments (DOE) A Guide for Optimizing Designs and Processes, published articles in Quality Progress, is a frequent contributor to Life Science Connect, and other recognized quality-related trade publications.

Areas of subject matter expertise include statistical quality and process control, sampling plans, equipment and facility qualification, process validation, design of experiments (DOE), process optimization, measurement systems analysis (MSA), and risk management.

Durivage primarily works with companies in the FDA regulated industries (medical devices, human tissue, animal tissue, cosmetics, and pharmaceuticals) focusing on quality management system implementation (QMS), integration, updates, training, and auditing (internal, supplier, and compliance). Additionally, he assists companies by providing internal and external audit support as well as FDA 483 and Warning Letter response and remediation services. Additionally, he also assists and supports organizations with ISO 9001, ISO 13485, ISO 14001, ISO 15378, ISO 17025, and ISO 45001 systems with implementation, integration, updates, training, and auditing (internal, supplier, and compliance).





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