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8th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

Philadelphia, USA

Michael D Spangler

Michael D Spangler

Spangler Consulting LLC, USA


Michael D Spangler has founded Spangler Consulting LLC in 2009. His clients engage him for assessments and remediations of quality systems and QMS programs, as well as for his CMC and analytical development expertise. He has direct clients, and also provides his services through larger consulting firms like The Quantic Group and QSC. His consulting value draws from his 25 years of pharmaceutical industry experience in analytical development, as a Senior Principal Scientist, CMC Author, People Manager, Project Team Leader, and as a participant in a Consent Decree Remediation. He is well published, presents regularly, and has invented several novel testing techniques. He holds a BS Degree in Chemistry and MS Degree in Industrial Pharmacy.


Abstract : A blueprint for outsourcing audits of approved GxP validations