IPEC-Americas and IPEC Europe have jointly published a guide for excipient makers and users on co-processed excipients. This guide offers best practice and voluntary guidance on the development, manufacture and use of co-processed excipients and provides support to both manufacturers and users of co-processed excipients.
Co-processed excipient users are responsible for assuring fitness for purpose and that the co-processed excipient and its components are manufactured to acceptable good manufacturing practice (GMP) standards. The guide facilitates communication between excipient users and suppliers regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.
Who Should Attend:
The following employees of CPE excipient makers and users (pharmaceutical companies):
- Regulatory Affairs
- R&D / Technical Service
- Product Safety / Toxicology
CPE Users (Pharmaceutical Companies)
- Regulatory Affairs
- Compendial Affairs
- Safety / Toxicology
- Provide history of co-processed excipients (CPE)
- Discuss the need for a CPE Guide
- Discuss and define single-entity, mixtures/blends, and CPEs
- Are CPEs new or novel?
- Discuss regulatory implications of CPEs
- The Co-processed Excipient Guide organization and content
- List and discuss benefits of the Co-processed Excipient Guide
- Present CPE case study
Joseph provides product and technology training for customers and IMCD staff, conducts on-site customer seminars, and advises with formulation development through excipient and process selection. Mr. Zeleznik also works to develop prototype formulations demonstrating the benefits of the many IMCD products and technologies. Prior to joining IMCD US, Mr. Zeleznik served as Manager, Technical and Regulatory Affairs at MEGGLE USA, Inc., where he was responsible for providing formulation and product application guidance as well as having quality and regulatory oversight for MEGGLE USA’s North American lactose manufacture. Before working for MEGGLE USA, Mr. Zeleznik was Associate Director, R&D with JRS PHARMA and Research Manager with Penwest Pharmaceuticals Co. Mr. Zeleznik has over 25 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 performance enhancement of excipients and pharmacologically active ingredients. Mr. Zeleznik received his B.S. and M.A. degrees in Chemistry from the State University of New York, College at New Paltz with a focus on instrumental analysis.
Mr. Zeleznik serves as a member of IPEC-Americas Executive Committee and has Chaired IPEC-Americas Quality by Design/Excipient Composition (QbD/EC) committee as well as assisted in the development of several IPEC Guides including the newly introduced Co-processed Excipients Guide.
Mr. Zeleznik has authored or co-authored multiple articles published across various industry journals. He was a contributing author to the Handbook of Pharmaceutical Excipients, 8th Ed. published in 2017 and participated in the development of the NF co-processed excipient monograph, Silicified Microcrystalline Cellulose.
Mr. Zeleznik is an avid outdoorsman, enjoying camping, hiking, biking, and wildlife photography and has been active as a cub scout and boy scout leader with Boy Scouts of America for many years.