Helping you build a healthier world.
Green Mountain Quality Assurance (GMQA) consulting combines scientific, quality, and compliance expertise to provide thoughtful and pragmatic solutions to your business improvement and compliance needs -- with the ultimate goal of helping you assure patient safety, product quality, and data integrity. Since 1992, GMQA consulting has supported a diverse range of clients, both domestic and international, including pharmaceutical, biotechnology, medical device, contract laboratories, and universities. We are a small firm; working with highly-experienced and dedicated consultant is guaranteed.
GMQA approaches each project with passion and personalized attention to detail. We enjoy challenges and the thrill of helping you successfully integrate people, processes, technologies, and quality systems to do what you strive to do best: discover, test, manufacture, distribute, and continue to assure the on-going safety of the highest quality pharmaceuticals, biologics, medical devices, and combination products.
Example services we provide include:
DATA INTEGRITY GOVERNANCE PLANNING / DATA PROCESS ASSESSMENTS / QUALITY AUDITS & INSPECTIONS / CONSULTING / TRAINING
President and Founder, Green Mountain Quality Assurance, LLC
Monica has 25+ years consulting experience with specialized interest and enthusiasm for Data Integrity Assurance & Data Governance in the emerging Knowledge Economy, Critical Thinking and Quality Culture Change Management, Operational Excellence and Technology Adoption, Personalized Medicine & Pharmacogenomics, Bioanalytical / Toxicology Laboratory Compliance, and general Quality Systems, including Training, Computerized Systems Validation and 21 CFR Part 11 Compliance.
Monica has worked with domestic and international Health Authorities and companies regulated by FDA GMP, GLP, GCP, QS Reg, BA/BE, VICH, OECD GLPs, as well as in University and R&D settings. Monica is a frequent lecturer and author of articles, book chapters, and newsletters.
Monica holds a B.A. Biochemistry from Dartmouth College, a M.S. Genetic Toxicology from M.I.T., is a member of PDA, ISPE, SQA, NERCSQA, DIA and is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP).
Click here for Monica's CV.
What others say about our training sessions:
Monica's knowledge of the material was fantastic. She explained complex material with excellent clarity. But the best part of her presentation was her enthusiasm keeping everyone engaged — no mean feat.
One of the best (if not THE best) I've attended. I've attended lots on the subject.
Very good speaker — knows subject at expert level. Very realistic and pragmatic approach.