Miguel Castillo-Alonzo

President @Anmac Global Consulting

Comprehensive experience with the processes and procedures related to compliance with the US FDA regulations, as well as Canadian, European Union, British, Australian, Japanese, and ISO requirements. Overhauled and resolved deficiencies in the Quality System. Presentations and Public Appearances• Keynote speaker on Introduction to Transdermal Drug Delivery System (1 day) and Data Integrity workshops (1 day) sponsored by the School of Pharmacy of Concordia University. Wisconsin• Webinars on Failure Investigation and CAPA for the Pharmaceutical Industry (1 day) and Failure Investigation and CAPA for the Medical Device Industry (1 day).• Keynote speaker on Validation Introduction (2-day) during the Sixth Annual Reviews Conference sponsored by the Institute for International Research.• Keynote speaker on optimizing any type of data for Improved Quality Products and Data Integrity (3-day) during the Fifth Annual Reviews Conference sponsored by the Institute for International Research.• Keynote speaker on Optimizations of Manufacturing Processes and Scale up for drug manufacturing (2-day) and Quality Risk Management (1 day) during the Fourth Annual Reviews Conference sponsored by the Institute for International Research.IN A NUTSHELLMy background includes: Project Management, LEAN Implementation/ Kanban/Just In Time (JIT), Six Sigma Methodology, Value Stream Mapping, World Class Manufacturing Principles (WCMP), Current Good Manufacturing Principles (cGMP), Supply Chain Design Strategy, Design for Manufacturability and Assembly (DFMA), Failure Mode Effects Analysis (FMEA), Critical Path Models (CPM), Design of Experiments (DOE), Statistical Process Control (SPC), Benchmarking, Manufacturing Resource Planning (MRP), Enterprise Resource Planning (ERP), Enterprise Scheduling System (ESS), Product Data Management (PDM), Production Inventory Management (PIM), Production Methods, Supply Chain Management, Business Process Re-engineering, Process Capability.