Michael Spangler is a senior CMC – analytical development – Quality consultant to the global pharmaceutical industry. He began in big Pharma including 20 years at the Schering-Plough Research Institute within analytical development. Michael moved to consulting for large and small companies in 2009. He authors module 3 CMC regulatory content and manages CMC programs, assesses and remediates 483s, Warning Letters, and Consent Decrees, helps clients build and upgrade Quality Systems and QMS programs, clears backlogs of Quality deliverables, and he remains active as a GMP analytical development, validation, and stability SME.

Michael is well published, he presents and teaches regularly, and has invented several novel testing techniques. He holds a BS in Chemistry and an MS in Industrial Pharmacy.