FDA Consultant Donna Hartzfeld, PHD


Analysis of processes, pipelines, and practices to assess compliance with procedures and regulations.
  • Pharmaceuticals
  • Medical Devices
  • Combination Products
  • Gap Analysis
  • Due Diligence
  • FDA PAI Readiness
  • Supplier Audits
  • Analytical Testing Laboratories
  • ISO13485:2016
  • Data Integrity

Employee Training

Coach and train employees to meet regulatory requirements in performing their roles and responsibilities.
  • SOP Training
  • Classroom Training
  • Remote Training (Webinars, Skype)
  • Coaching
  • Hands-On Demonstration
  • Quality Systems Training
  • Regulatory Training
  • Analytical Laboratory Training
  • Good Manufacturing Practices
  • Good Documentation Practices

Quality Systems

Assistance with establishment and implementation of sustainable and compliant quality systems.
  • Documentation Writing
  • Inspection Readiness Planning
  • FD-483 and Warning Letter Support
  • Internal Audits
  • Start-Up Company Coaching
  • CAPA Investigation Support
  • Benchmarking
  • Upgrades
  • CMC Consulting
  • Regulatory Submission Support


Provides support for production systems and testing methods that creates product that meets specifications.
  • Documentation Writing
  • Batch Record Reviews
  • Validation Support
  • Aseptic Sterile Controls
  • ISO Clean Room Standards
  • Analytical/QC Support
  • Warehouse, Materials, Facilities
  • Design Controls Support
  • OOS Investigation Support
  • Test Methods Support

Meet Donna Hartzfeld, PHD

Donna Hartzfeld, PHD

Donna Hartzfeld, PHD

FDA Consultant
  • Dr. Donna Hartzfeld is President & CEO of Quality Implementation Services, Inc. founded in 1999 and based in Gilbert, AZ. Dr. Hartzfeld holds a PhD from Arizona State University in Organic Chemistry.
  • Dr. Hartzfeld is a Global FDA Compliance Consultant with 25 years experience working in scientific research and FDA-regulated environments including pharmaceutical drugs, medical devices, biologics, and combination products.
  • Dr. Hartzfeld has worked in companies ranging from small start-ups to international large companies.
  • Invited USA Scientific Researcher: Advanced Study Institute School on Photobiology in Medicine, Sardinia, Italy
  • Her compliance expertise includes all aspects of device and drug quality systems, analytical laboratory controls, manufacturing process and validations, including sterile aseptic manufacturing, and CMC regulatory requirements.
  • Dr. Hartzfeld holds an Auditor certificate for ISO 13485 medical device manufacturing standard and is an expert Auditor of FDA regulated quality systems, due diligence, FDA inspection readiness planning and FD-483/Warning Letter remediation activities.
  • Dr. Hartzfeld provides training, coaching and hands-on instruction in order to help a company meet compliance.
  • Dr. Hartzfeld was formerly the Quality Assurance Director at OrthoLogic, where she managed quality assurance activities for a clinical stage wound healing drug product. She has held positions as a senior consultant with IQVIA consulting services, NDA Partners, LLC, the National Science Foundation Health Sciences Pharma Biotech Consulting, Quintiles Consulting, Marion Weinreb & Associates, and Precision FDA Consultants.

A Few of Our Testimonials

I have worked with Donna Hartzfeld, Ph.D. at several companies and have found her to be professional, knowledgeable, and very proficient in medical device manufacturing practices. At Biomerics, she offered consulting services to prepare us for a combination medical device/pharmaceutical product. Her knowledge was useful in creating a gap analysis for quality system implementation. At MedPlast, She was invaluable in writing quality system documentation and improving our quality system. She was very thorough and professional in handling difficult situations and personalities. She also produced excellent quality work in a short period of time, which aided us in meeting our system deadlines. At Katecho she performed our ISO/FDA internal quality audits. She was flexible in handling our audits with very little notice and identified key areas to address our quality system deficiencies.

E. Madsen

QIS, Inc. was actively engaged in performing cGLP audits for our organization. In the midst of executing that task, QIS, Inc. eagerly switched gears and was instrumental in helping us reach our goal to submit the grant proposal on time. And the grant proposal proved successful for us

Michael Wilhelm

Dr. Donna Hartzfeld is an experienced consulting professional who has effectively led many teams in the areas of quality systems development, validation, and warning letter response. I have worked with Donna on multiple past projects in the medical device, OTC, and pharmaceutical industries and I would work with/for her again without reservation. She is a valuable asset to any project requiring technical knowledge, regulatory knowledge or skilled leadership to meet critical task deadlines.

Edward McKenzie

Certainly when you retain a regulatory affairs consultant, you look for subject matter competence.  Donna goes well beyond that, offering company-specific advice, understanding time sensitivity, and providing the care needed in a start-up environment.  I strongly recommend her.

Lubna Ahmad