Ronald Filipski is the president of PFP Consultants.  He has over 33 years of experience in the areas of Senior Management, Operations, and Compliance for the biotech, pharmaceutical, diagnostic and medical device industries.  He specializes in operations, compliance and due diligence contract work.  His former employers include Sanofi-Aventis, Hoffmann-La Roche and Zenith Laboratories, where he directed and managed Compounding, Filling, Inspection, Labeling, Packaging, Packaging Maintenance, Printing, Label Control, Distribution and Warehousing Operations for both sterile and oral solid products. He has a working knowledge of the associated equipment and facilities required for sterile pharmaceutical/biopharmaceutical and solid dose processing.  In addition, he lead and participated in global projects such as the implementation of barrier isolator sterile filling technology and the implementation of a new filling/packaging facility, that required the development of equipment specifications and procedures, the development and execution of validation protocols and the preparation of the associated Regulatory documents.  He has experience in the evaluation, selection and start-up of third party contract manufacturing and was the vaccine industry spokesman for the CDC vaccine identification labeling initiative.  He has significant knowledge of cGMPs pertaining to the manufacture of biological and pharmaceutical products and experience dealing with personnel at the FDA, USDA, EMEA and DEA on production and quality/project-related issues. 

Ron has been consulting for the Pharmaceutical, Device and Biological industry since 2000.    As a consultant, he has; lead consulting teams in third party consent decree evaluations of client documents and operations; assisted in compliance remediation activities; conducted facility/organization due diligence evaluations; identified, rendered operational and monitored contract manufacturing suppliers; and conducted compliance reviews/audits.

 Ronald Filipski earned a Masters of Business Management degree from Fairleigh Dickinson University and a Bachelor of Biological Science degree from the University of Cincinnati.  In addition, he earned his Packaging Professional Certification in 1990.