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

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

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

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

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

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