PME 535:Good Manufacturing Practice in Pharmaceutical Facilities Design
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.
Schaefer School of Engineering & Science
Department:
Mechanical Engineering
Nick Phillips has 30+ years experience in Manufacturing and Engineering, the past 25years holding positions in project and departmental management focusing on the Healthcare Industry. He has worked for Johnson & Johnson as the Manager of Project Engineering, American Home Products (now known as Wyeth as the Director of Engineering and at Colgate Palmolive as the Associate Director of Oral Care Engineering. For the past 9 years he has been with Lockwood Greene as Senior Consultant, Pharmaceutical/Biotech Manufacturing Technology: developing master plans and conceptual designs for: manufacturing systems, and production facilities. He received a BME and a MS in Management from Stevens Institute of Technology. His experience focuses on the design of pharmaceutical and parental facilities that meet all regulatory requirements with particular attention paid to FDA and EU, OSHA, and EPA. He has also audited facilities for many of the major pharmaceutical companies with regards to both CGMP and the handling of potent compounds. Nick is in his fourth year, as Adjunct Professor, teaching PME-535 Good Manufacturing Practice in Pharmaceutical Facilities Design. This course is one of the core courses for Stevens’ Pharmaceutical Engineering Certification Program. It is taught as a lecture course at Raritan Valley Community College and as an online course for Stevens award winning WebCampus. He has authored papers and presented seminars on Containment of Pharmaceutical Production Facilities and Pilot Plants and on Master Planning of Pharmaceutical Operations, which have appeared globally in print and on-line.
Research & Education
Education
He received a BME and a MS in Management from Stevens Institute of Technology.
Experience & Service
Experience
His experience focuses on the design of pharmaceutical and parental facilities that meet all regulatory requirements with particular attention paid to FDA and EU, OSHA, and EPA. He has also audited facilities for big pharma with regards to cGMP and containment. He has authored papers and presented seminars on Containment of Pharmaceutical Production Facilities and Pilot Plants and on Master Planning of Pharmaceutical Operations, which have appeared globally in print and on-line
General Information
Phamaceutical Manufacturing Program
(GMP Facilities Design) Mr. Phillips has 30+ years experience in Manufacturing and Engineering, the past 25 years holding positions in project and departmental management for the Healthcare Industry. For the past 9 years he has been with Lockwood Greene as the Technical Manager, Pharmaceutical/Biotech Manufacturing Technology: developing master plans and conceptual designs for: manufacturing systems, and production facilities.