Mr. Angelucci is a pharmaceutical professional with over 25 years’ experience in Quality Assurance, Quality Control, Regulatory Affairs, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. He has worked for several well-known companies including Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough, and Merck. His experience has been either as a direct employee or as a contracting consultant while employed at Foster Wheeler and Aker Kvaerner. As a consultant, Mr. Angelucci has worked at various project locations domestically and in Europe and Asia. Mr. Angelucci is a degreed engineer with two master’s degrees in engineering, holds industry certifications with ASQ as a CQE, CQA and CPGP. He is currently the ASQ Philadelphia chapter Education Chair. In addition, he holds a PMP certification through the Project Management Institute. He has published numerous articles about Validation and compliance and has been a speaker to industry groups such as ISPE, IVT, DIA, PDA, ASQ and CFPA. Lou is an experienced validation consultant with background in Pharmaceutical API, OSD, Parenteral and Aseptic/sterile manufacturing. Lou also has experience with medical device manufacturing and process validation having specialized in terminal sterilization techniques that include ETO, Steam, Cobalt and E-Beam processes. Lou has participated as the validation lead with numerous pharmaceutical and medical device clients for such things as equipment and facility qualification, tech transfer, and process validation.