GMP & Regulatory Training
Our trainers have hundreds of hours instructing adults at all levels of learning. We employ instructors with experience teaching regulatory courses at the university level as well as those who have presented at large and small companies and industry groups such as the American Society for Quality (ASQ). Additionally, we are experienced in training those for whom English is not their first language.
Our consultants excel in the development of curriculum/training, e.g., internal auditing program training, annual GMP training and compliance-based review of new or existing training programs.
Topic Expertise
- Inspection Readiness
- GMPs in general
- Quality Systems (e.g., investigating quality events)
- Facilities & Equipment (e.g., maintenance, design, cleaning validation)
- Utilities (e.g., water, steam, HVAC)
- Material Management
- Supplier Qualification
- Packaging & Labeling
- Contamination Controls
- Quality Control Laboratories
- Production Control
- Data Integrity
- And much more!
YouTube Community
Join our YouTube community for expert FDA compliance tips, insider advice, and the latest regulatory updates to stay compliant.
Recent Trainings
- Audit Like An Inspector
Health Authority Tools For Auditing & Inspection Readiness. See News for full presentation.
TESTIMONIALS
Our Clients & Partners Speak
My Preferred Choice!
Constance stands out as my preferred choice among ex-FDA consultants. Her approachable, down-to-earth demeanor makes communication effortless, fostering a collaborative working environment I highly value. Her expertise was pivotal in guiding my client through their remediation efforts, further solidifying my confidence in her abilities. Given her exceptional skills and easy rapport, I find it hard to consider partnering with anyone else.
Makes Auditing Work Fun!
Constance conducts cGMP audits in a very professional, fair manner and is extremely knowledgeable of FDA regulations and requirements. She possesses excellent communication, teaching and personable relationship skills and is very easy with which to work. She really makes auditing work fun!
One of the most knowledgeable individuals I have had the pleasure of knowing.
Having worked with Dr. Fears in academic research, federal regulatory and industrial manufacturing settings, she is one of the most knowledgeable individuals I have had the pleasure of knowing. She brings vast technical and regulatory expertise from her time in academia, the FDA and pharmaceutical industry. You can definitely trust that she is capable and driven to deliver the best possible outcome.
Our Product Expertise
Prescription and OTC
We offer GLP, GCP and GMP solutions for all types of drugs including biologics and vaccines, small molecules, APIs and drug substances. We have expertise in sterile injectables, solid oral dosages, ophthalmic, topicals etc. Our service offerings also apply to laboratory operations, product storage and distribution of drugs.
Medical Devices
We offer quality and GMP solutions for Class I, II, and III medical devices. See our service offerings.
Cosmetics & Cosmetic Ingredients
We offer quality and GMP solutions for Cosmetics and Cosmetic Ingredients. See our service offerings.
Food, Supplements & Beverages
We offer quality and GMP solutions for foods, dietary supplements and beverages. See our service offerings.
ISO-Certified Products
We offer quality and regulatory solutions for ISO-certified products, which can range from raw materials, defense, paper products, flooring, and other non-FDA regulated products. See our service offerings.
Dr. Constance Y. Fears
Meet Our Founder & Principal Polymath
Constance Fears brings two decades of technical, legal, and pharmaceutical manufacturing experience to Polymath. She holds a Ph.D. in Cellular and Molecular Biology, Juris Doctor (law, regulatory law), and graduate diploma in International and French Law. Drawing on her diverse educational background, she has held various positions including, molecular biology post-doctoral research fellow, tenure-track university professor, US FDA Certified Drug Investigator and Director of Quality Systems & Compliance at one of the world’s largest pharmaceutical companies. Combining formal education and professional experience, she offers a broad perspective to solve complex quality and compliance issues as a technical and regulatory expert.