Our Approach

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

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Our Team

 

Monica Cahilly
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.


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Peter Baker
Vice President, Green Mountain Quality Assurance, LLC

Peter E. Baker spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile.  Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. His inspection experience includes performing six systems manufacturing inspections of API’s, intermediates, and finished dosage, including complex small and large molecules.

Peter specializes in training specifically on Good Manufacturing Practices and Quality Culture; he believes that one of which cannot exist without the other.  He has organized and executed training programs around the world, tailored for both Industry and National Health Authorities.  Past topics have included basic to advanced GMP, biotherapeutics and advanced cell therapies, investigations and CAPA, inspection techniques, data integrity, and quality culture, among others.

 Peter holds a Bachelor of Science (B.S) degree in Biology-Chemistry from Point Loma Nazarene University, a Masters of Science (M.S.) in Chemistry from San Francisco State University, and is an active member of PDA, DIA, and ISPE.

Click here for Peter’s CV.