NSF-DBA has added five pharmaceutical experts to provide consulting and in-house training services to help companies comply with international regulations and improve quality management systems.
Ed Arling, formerly an investigator with the State of Illinois and the FDA, has more than 30 years experience leading quality assurance and regulatory compliance programs for pharmaceutical companies including Pharmacia, Pfizer and Amgen. He currently focuses on quality system assessments, pre-approval inspection readiness, deviation and CAPA (corrective and preventive action) management and related regulatory activity.
Peter H. Calcott, Ph.D., former chair of the Biotechnology Industry Organization Regulatory Affairs committee, has more than 30 years of experience in the pharmaceutical industry having held senior positions in quality, R&D, regulatory affairs, process development and manufacturing at Chiron, Immunex, SmithKline Beecham, and Bayer.
Stan Cryz Ph.D., a specialist in the area of bacterial and viral vaccine development, characterization and clinical evaluation, has more than 30 years of experience in R&D and biologics manufacture. Dr. Cryz most recently served as deputy director of development and production for MassBiologics, a manufacturer of vaccines and biologics in the U.S.
Matt Krsulich M.S. is an analytical chemist and pharmacologist with 30 years of pharmaceutical quality management experience. Mr. Krsulich previously managed QC operations and regulatory CMC (Chemistry Manufacturing Controls) projects at Pfizer and has experience with global GMP requirements and quality systems.
Luba Skibo M.S., an analytical chemist with 20 years of experience in the pharmaceutical industry, has worked at Pfizer and most recently served as the director of regulatory affairs for Merial Ltd. Pharmaceuticals managing global regulatory strategy and the post-approval management team for pharmaceutical and biological products.
“The complexity of pharmaceutical production and regulations demands experienced trainers and consultants who can offer expert guidance to companies and high quality education courses,” said Bob Pietrowski, Ph.D., managing partner of NSF-DBA. “We are pleased to welcome these individuals to the NSF-DBA team as together they bring over 140 years of combined expertise.”