Regulatory Compliance Expert

Dr. Steiner has over 35 years working in the pharmaceutical and medical device industry.  He entered industry as a Ph.D. chemist working in Research & Development and then Process Development and Process Engineering.  With this diverse technical background Dr. Steiner transitioned in Quality Management (Quality Assurance/Quality Control) in roles with increasing responsibility.  During this time, he also earned a certification in Regulatory Affairs from San Diego State University and became an ASQ Certified Quality Auditor (CQA).  The last 12+ years working full time at pharmaceutical/bio-pharmaceutical and medical device companies Dr. Steiner was department head for Quality Assurance and in some positions also for Quality Control.

Now Dr. Steiner uses his extensive technical background (including materials science: adhesives & composites) and knowledge of Quality Systems assisting companies in building quality systems, maintaining regulatory compliance, process validation, regulatory compliance audits (primarily FDA & EU).  Dr. Steiner is unique in that his strong technical background enables him to be accepted and interact with Operations while moving companies towards greater regulatory compliance.

Steiner Consulting
Typical Medical Device Verification & Validation (V&V) Tree
Steiner Consulting

American Society for Quality Certified Quality Auditor (ASQ CQA)

Dr. Steiner has been a certified quality auditor for over 17 years performing hundreds of quality (regulatory compliance & ISO) audits over four (4) continents in a variety of industries (pharmaceuticals, medical devices, chemicals, aerospace, miscellaneous commercial manufacturing and software.

 

Expert Witness

Dr. Steiner’s technical expertise (process development/engineering, adhesives, composites) and knowledge of regulatory compliance (FDA) has enabled him to be recognized by the US Federal Courts as an Expert.  He is also recognized by many state courts as an Expert in these same areas.

 

Quality and Compliance Presentations and Recent Publications

Dr. Steiner has advised companies about quality and compliance.  Most of these companies were involved in medical devices, pharmaceuticals/bio-pharmaceuticals or combination devices which require compliance to FDA and/or EU Regulations.  Some of these companies as well as companies in other industries were seeking compliance to ISO standards such as ISO 9001, an international standard that specifies requirements for a quality management system (QMS).

The two attached presentations provide an example of Dr. Steiner’s passion in these areas.

 

Recent Publications

“Phase Appropriate cGMPs: The Virtual Company”, Davis Healthcare International Publishing, 2017. https://www.amazon.com/Phase-Appropriate-GMP-Biological-Processes/dp/1942911173/ref=sr_1_1?dchild=1&keywords=phase+appropriate+gmp&qid=1595365149&sr=8-1