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This webinar will discuss additives and “impurities” as they relate to excipients, including concomitant components, why they’re important to excipient function, and regulatory implications of these various entities (e.g., USP General Chapters).
After completion of this webinar you should be able to:
- Understand some common ground and differences between APIs and excipients.
- Gain insight to often complex excipient composition.
- Understand the differences with concomitant components, additives, and impurities.
- Understand some important regulatory concerns Industry is facing.
- Learn about activities underway to resolve such regulatory concerns.
For the past four years, Mr. Zeleznik has served as Manager of Technical Affairs with MEGGLE USA. In his role, he is responsible for providing formulation and product application guidance as well as having quality and regulatory oversight for MEGGLE USA’s North American lactose manufacture. Prior to joining MEGGLE USA, Mr. Zeleznik was Associate Director, R&D with JRS PHARMA and Research Manager with Penwest Pharmaceuticals Co. Mr. Zeleznik has over 18 years’ experience in the pharmaceutical industry, having specialized in the development and application of high functionality excipients and in particular, co-processing applications for the enhancement of excipient and pharmacologically active ingredients performance. He holds several patents in areas of product and process development, formulation development, and API co-processing. Mr. Zeleznik has authored or co-authored several articles published in various industry journals. He holds a Master’s Degree in Chemistry from the State University of New York.
BS from UCLA in BioChemistry
1980-1984 Colorado State University Veterinary Teaching Hospital- Equine Research Animal Attendant
1984-1989 RT Vanderbilt Co- R&D and International Sales
1989-present Vanderbilt Chemicals LLC- VP and Mgr Minerals Division
IPEA GMP Certified Auditor Training 2012
IPEC Americas member since 2011
Compendial Review Committee Vice Chair 2015 to present
IPEC USP General Notices Team 2016 to present