Blood, Biologics and Tissue Products

Some of the most challenging areas to maintain compliance to FDA regulations include blood, blood derived products, and blood screening tests, tissue and bone based products, and biologics.  QIS provides…

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Dietary Supplements

Manufacturers of Dietary Supplements are responsible to evaluate the identity, purity, quality, strength, and composition of their products to meet 21 CFR Part 111 regulations for Good Manufacturing Practice (CGMPs)…

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Pharmaceutical

QIS, Inc. helps companies meet the standards set by the FDA. QIS, Inc. provides a full spectrum of services to assist drug companies gain a state-of-control in their quality and…

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Combination Product

The combination product market has unique challenges but is one of the most transformational areas of Life Sciences. Predictions determine that combination products (Rx, Dx, Device) are going to be…

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About Us

Since our inception in 1999, QIS FDA Consulting has developed a reputation for success. Our commitment to client satisfaction has …

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Clients

Our client base is very diverse as we serve in many areas. We have provided a few examples of our …

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Why Choose QIS

Integrity We focus our work on optimizing and stream-lining the systems already in place—not necessarily on replacing them.  Our approach …

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Services

FDA Consultant Donna Hartzfeld, PHD

Audits

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
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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
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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
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Manufacturing/Testing

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
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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

Donna Hartzfeld PhD has provided consulting expertise as we respond to a Warning Letter.  Senior and Junior manufacturing staff have benefited from her considerable teaching skills.  Her ability to lead, her extensive experience, and her attention to detail have proved invaluable. 

S. Beenken, M.D.

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

Donna has been both adviser and regulatory consultant to Mission3. In both capacities she has been professional, knowledgeable, and thorough. Her ability to find the right answer and do work with incredible level of quality makes her an incredible asset to any team. She is personable and easy to work with

Dirk Beth

Dr. Donna Hartzfeld, and her company QIS, have been consummate professionals in every task. She has proven not only to be extremely knowledgeable technically, but also an expert in client relationship management. Dr. Hartzfeld is the first person I call whenever I have need of a qualified and dedicated scientist.

John Little