Accomplished executive in the areas of Quality, Regulatory, Compliance, R&D for existing and new ethical and OTC pharmaceutical drug products with top tier corporations (Novartis, Pfizer, Warner Lambert, DuPont Merck, Baxter and BMS). Extensive technical and management experience in developing, implementing and administering strong programs supporting GXP operations from formulation into development through the post marketing lifecycle.
Accomplished executive in the areas of Quality, Regulatory, Compliance, R&D for existing and new ethical and OTC pharmaceutical drug products with top tier corporations (Novartis, Pfizer, Warner Lambert, DuPont Merck, Baxter and BMS). Extensive technical and management experience in developing, implementing and administering strong programs supporting GXP operations from formulation into development through the post marketing lifecycle. Extensive interaction, experience and interface with FDA and international Regulatory Agencies. Hands on operations management in the Pharmaceutical and Biotechnical industry with international experience.
Specialties: QA / QC
Warning Letter & Consent Decree Assistance
API & Finished Dosage Forms
Global GCP, PV, RMP & Signal Detection, REMS
Clinical Ops & Trial Management
Due Diligence Audits
Audit Functions & CAPAs
Promotional & Marketing Practices
Vice President, Regulatory Compliance @ From June 2015 to Present (6 months) Coppell, TXExecutive Director, Corporate Compliance @ GXP Compliance Management From July 2012 to January 2015 (2 years 7 months) East Hanover, NJPresident @ PCSglobal offers the Pharmaceutical, Biotechnology and Medical Device industries the opportunity to outsource Compliance and Risk Services at a cost effective price. Our consultants specialize in activities related to Safety Signaling, Auditing, Pharmacovigilance, Risk Management, Inspection Readiness, Compliance, Complaint Handling and all aspects of GxP. We conduct audits and deal with crisis management situations all over the world. Our company is dedicated to understanding and adhering to client needs, reducing operational risks, and ensuring safety from a global perspective. Our outsourcing structure allows us to provide these services in a cost effective way.
We help companies to address urgent and routine issues by quickly mobilizing teams of trusted, highly qualified professional industry veterans with integrity, special skills and relevant knowledge who possess decades of collective experience and the expertise to accomplish your goals. From May 2011 to July 2012 (1 year 3 months) Flourtown, PADirector, Quality Assurance @ From 1991 to 2009 (18 years) Associate Director @ From 1987 to 1991 (4 years) Manager Biocontrol @ From 1981 to 1982 (1 year)
BS, Zoology, Chemistry @ Clemson University From 1973 to 1977 Toms River High School North From 1969 to 1973 Barry Poretskin is skilled in: Regulatory Affairs, Quality Assurance, Quality Control, Document Management, Due Diligence, FDA GMP, FDA, GxP, GCP, ICH-GCP, Drug Development, IND, Quality System, Therapeutic Areas, CMC, Auditing, Validation, CAPA, Medical Devices, Pharmaceutical Industry, Management, CTMS, Risk Management, Clinical Research, Change Control, Regulatory Submissions, Biotechnology, Quality Management, Strategy, 21 CFR Part 11, eCTD, Business Strategy, Pharmacovigilance, Clinical Development, V&V, GMP, Clinical Trials, Aseptic Processing, Cleaning Validation, Pharmaceutics, Drug Safety, Program Management, Software Documentation, Biopharmaceuticals, ISO 13485, Computer System..., ISO, Regulatory Requirements, GLP, Biotechnology Industry
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