Andrew Stasiak is a Certified Quality Auditor who currently serves as Director of Quality at Medivant Healthcare (Tailstorm Health, Inc.), the newest, sterile single dose liquid injectable facility in the US, dedicated to manufacturing medications on the FDA’s drug shortage list. He specializes in pharmaceutical audits and is considered a subject matter expert in the fields of Computer Systems Validation, as well as process validation.
Based in Phoenix, Arizona, Medivant Healthcare’s fully automated cGMP sterile injectable pharmaceutical manufacturing facility will begin commercial production in early May 2020. Medivant’s initial products will include liquid injectables that are in dire need in the ICU for Covid19 patients.
Hired during the design and development of the aseptic parenteral manufacturing facility, Stasiak has worked to bring the organization from an empty building through systems development and into FDA compliance for the manufacture of sterile drug products. Stasiak was directly involved in the hiring of all staff, all validation activities, development of all procedures, training employees, and all other activities to bring the pharmaceutical company into production.
He currently oversees all Quality Assurance and Quality Control activities as well as indirectly supervises manufacturing activities. Stasiak authored approximately 80% of all Standard Operating Procedures and oversaw the design, commissioning, and validation of all equipment and procedures. He is the Point of Contact for regulatory interactions for the FDA, DEA, and Arizona Board of Pharmacy. Additionally, Stasiak manages the final release of drug product for human use.
Having earned his Masters of Science Degree from San Diego State University, Stasiak is a demonstrated leader in FDA compliant quality operations who has overseen a variety of global pharmaceutical and medical device manufacturing, testing, and clinical programs. Prior to Medivant Healthcare, Stasiak supervised quality control for a wide variety of organizations including Hollister-Stier Laboratories, Insys Therapeutics, and W.L Gore and Associates.
Stasiak has developed, implemented, and expanded quality systems for organizations large and small and has extensive experience with global regulatory compliance. He is the subject matter expert in the areas of sterile pharmaceutical manufacturing, process validation, computer system validation, and laboratory equipment validation and has successfully led organizations through many regulatory inspections and has performed more than 100 cGMP, GLP, and GCP audits in 20 countries.
For more information about Medivant Healthcare, please click here.