CONSULTANT IN ADHESIVES, FIBER COMPOSITES, FDA REGULATORY COMPLIANCE
& EXPERT WITNESS SERVICES

Over 35 Years of Experience as a Material Science Consultant and
a Quality Systems Expert as well as a Regulatory Compliance Strategist

(650) 346-2990

SUPERIOR CONSULTING AND EXPERT WITNESS SERVICES FOR ADHESIVES AND FIBER COMPOSITES

Thank you for visiting. With over 35 years in the industry, Dr. Paul Steiner is available to serve you as an expert consultant or expert witness in all areas related to developing, formulating, testing, cure cycle developments, manufacturing, and testing in a wide variety of applications from aerospace to electronics to medical devices, packaging, and construction.

Dr. Steiner is your source for advice on adhesive sourcing, adhesives selection, and cure cycle development and bond construction . His expertise covers adhesive classes including epoxies, FR4 flame retardant epoxies, bismaleimides, polyimides, cyanoacrylates, PSAs, specialty adhesive formulations, and process development/process engineering, fiber composites include use of carbon/graphite, glass and aramid fibers Verification; Validation (V&V) services.

Your Adhesive and Fiber Composites Specialist Comprehensive Adhesive/Composites Information

  • Adhesive bond improvement
  • Adhesive expert witness, intellectual property disputes, and attorney research support
  • Adhesive environmental testing: water, solvent, thermal
  • Biomedical adhesive applications
  • Replacements for VOC solvent formulations
  • Adhesive failure analysis, troubleshooting, applications
  • ASTM and Mil Standards testing
  • Adhesive search, source selection, application testing
  • Liaison to adhesive specialty formulators
  • Adhesion formulary for metals, wood, glass, plastics, FRPs, ceramics, etc.
  • QC laboratory testing
  • Adhesive & composites expert….
  • Composites fiber/resin interphase optimization and troubleshooting
  • Composites Fabrication Processes (Hand Layup, Filament Winding, and RTM)
  • Verification & Validation (V&V) services
Steiner Consulting
Steiner Consulting
The 7 subsystems of a Quality System

Regulatory Compliance Expert Quality and Compliance

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.

Warning Letters

Now Dr. Steiner uses his extensive technical background (including materials science: adhesives & composites) and knowledge in building Quality Management Systems (QMS), maintaining regulatory compliance, process validation, regulatory compliance audits (primarily FDA & EU). He is able to lead diverse groups through Root Cause Analysis, Failure Modes and Effects Analysis (FMEA), Quality by Design (QbD), the FDA (or ICH) QSRs (Quality System Regulations) and responding to FDA Warning Letters.

 

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 numerous companies about building compliant systems and performing and addressing GAP Analysis for existing quality quality systems. Most of these companies were involved in medical devices, pharmaceuticals/bio-pharmaceuticals or combination devices all of which require compliance to FDA and/or EU Regulations. Some of these companies were seeking compliance and or testing 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

AVAILABLE FOR ADHESIVE/FIBER COMPOSITES AND/OR REGULATORY COMPLIANCE AND EXPERT WITNESS SERVICES

Skilled Adhesive Professionals

Skilled Adhesive Professionals

  • Adhesive/fiber composite expert
  • Adhesive/fiber composite applications and process development
  • Biomedical adhesive & fiber composite applications
  • Root cause Failure and Risk analysis
  • Process verification & validation (V&V)
  • Adhesive design selection
Quality Systems

Quality Systems

  • FDA GMP (GCP, GLP) compliance
  • EU and ICH Q10 compliance
  • Building and implementing Compliant Quality Systems
  • American Society for Quality (ASQ) Certified Quality Auditor (CQA)
  • Failure Modes and Effects Analysis (FMEA)
  • Compliance Training
  • Responding to FDA Warning Letters (483’s)
Management

Management

  • Active Pharmaceutical Ingredients (APIs) and biologic Drug Substances (DS)
  • GMP processing: small molecule chemical manufacturing & Large Molecule Biologic aseptic processing.
  • Finished drug packaging
  • Shipping logistics environmental controls
  • Establishing expiry dating
  • Contract Testing Organizations (CTO’s) and Contract Manufacturing Organizations (CMO’s)
  • Chemical Manufacturing Control (CMC)
Papers and Patents

Papers and Patents

Published fifteen peer-reviewed papers to date and several granted patents in the fields of:

Phase Appropriate cGMPs. The virtual company, CMOs and compliance audits.

  • Adhesives
  • Resins
  • Fiber Resin Interphase
  • Epoxies
  • Composites
  • Contact Angles and Surface Wetting

Articles

“A Graded or Risk-Based Approach to cGMP Compliance for API Manufacturing.”

Covers such topics as Regulatory Status of APIs in the US, Q7A, ICH, API Production Designation, and the spectrum of cGMP Controls.

“Project Elements of Design Control, Design of Experiment (DOE) and Risk Analysis (FMECA)”

Covers such topics as History of “Quality” and roots of Design Control and Risk Analysis, Failure Mode and Effects Analysis (FMEA), DFMEA, PFMEA, Failure Mode, Effects, and Criticality Analysis (FMECA ), Product Development Process, MIL STDS, International Organization for Standardization (ISO) 13485, 14971, FDA QSR 820.30(c) and (g), Medical Device Directives, Design Control and Design of Experiments (DOE), and Risk Analysis among other topics.

Adhesive Failure & Epoxy Failure

Many of Dr. Steiner’s expert consulting or expert witness engagements concern actual or suspected failure in adhesive and epoxy bonds in aerospace, medical device, pharmaceuticals, packaging, industrial, and construction applications. In fiber composites, the issues typically revolve around suspected cracks/micro-cracks, which might result from improper fabrication/processing or stresses experienced during use and especially cyclic stresses.

testimonial

Steiner Consulting

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Diane Williams

Medical Devices
Steiner Consulting

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Diane Williams

Aero Space

Contact Dr. Steiner

Available for Adhesive/Composites consulting and Expert Witness services and/or your regulatory compliance needs and Expert Witness services.

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