This webinar will discuss additives and “impurities”, including concomitant components, as they relate to excipients, why they’re important to excipient function, and regulatory implications of these various entities (e.g., USP General Chapters).
This Webinar is recommended for individuals who work with pharmaceutical excipients in the following function(s):
- Formulation chemists
- R&D / technical service personnel
- Production supervisors and managers
- Quality and regulatory personnel
- Sales and marketing executives.
After completion of this webinar you should be able to:
- Describe some commonalities and differences with APIs and excipients
- Explain some reasons for complexity of excipient composition
- Distinguish between additives, concomitant components, and impurities related to excipients
- List some important Regulatory concerns Industry is facing concerning these ingredients in excipients
- Describe some activities underway to resolve the regulations
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