Ms Mary L Davis
Consultant
ASQ Certified Quality Auditor
- [email protected]
- + 1 857 277 0060
Mary has more than 35 years’ experience in the pharmaceutical industry with 33 years broad based experience in cGMP/cGLP compliance and quality systems related to biotechnology, small molecules, sterile manufacturing, solid oral dosage forms, and dietary supplements. For the past 15 years she has specialized in compliance auditing, having conducted nearly 400 GMP and GLP audits, including internal systems audits, vendor qualification, and routine surveillance audits. Audited GMP facilities cover all phases of API/drug manufacturing including API manufacturers; formulations/fill/finish facilities including sterile operations; test laboratories; clinical and commercial packaging, labeling, and distribution centers; and a variety of specialty suppliers of raw materials, intermediates, packaging materials, and printed labeling. Her GLP auditing experience includes both pre-clinical test facilities and bioanalytical laboratories.