Discussed why chemical ingredient distributors are an essential segment of the supply chain - providing excipients to developers and manufacturers of drug products as well as providing additional security of the overall supply chain for drug products. Many excipient and drug product manufacturers do not fully understand the complexities and critical function of the excipient distributor. Excipient and drug product manufactures are obligated to fully understand the total supply chain, its complexities and potential limitations. This webinar is designed to facilitate the who, what, when, where, how and why of excipient distributors.
- How distributors can help understand supply chain essentials
- Quality system certification expectations and realities
- Bridging product stewardship and managing the chain of custody between excipient suppliers and excipient users
- Expectations for distributors who repackage, blend or relabel the excipient
- What CoA and documentation provided, origin of information it contains and why material grade/product codes matter
- The ins and outs of distributor audits
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.
With over 35 years of experience in manufacturing, operations and logistics related to the pharmaceutical business, Zezette McCoy currently serves as National Quality and Regulatory Manager at IMCD US, Pharma Division. In her current role, McCoy is responsible for the managing the quality programs related to warehousing, distribution and repacking services of excipients. She is also a regulatory liaison to IMCD valued customers and principals as well. She began her career at IMCD US LLC (aka Mutchler Inc) in 2007 as Operations Director leading the warehousing and distribution activities at their Puerto Rico site.
After graduating from the University of Puerto Rico with a bachelor of science, BS, degree in Biology, McCoy joined Schering Plough in Puerto Rico as a Parenterals Manufacturing Supervisor. While with Schering she advanced through various managerial positions in the operations arena including Sterile Operations, Cream and Ointments and Aerosols. During her 24-year career at Schering, McCoy also served as a Director within their logistic department while the company operated under a five-year consent decree.
McCoy is an active member of IPEC-Americas and a contributor to the 2017 revision of the IPEC Good Distribution Practice Guide for Pharmaceutical Excipients. She is also a member of both the Puerto Rico Manufacturing Association and Puerto Rico Pharmaceutical Industry Association.
Passionate about “doing things right, the first time”, McCoy enjoys coaching young professionals to help them advance in their career objectives.
Currently the Eastern USA Regional Quality Manager for Univar Solutions, Charlotte McIlvaine is a seasoned quality assurance manager and analytical chemist with deep expertise in the pharmaceutical industry. McIlvaine began her career as a bench chemist and worked for various small pharmaceutical manufactures in Quality Control and Quality Assurance roles. She joined Univar Solutions in 2015 as Quality Manager for two districts where she was the primary contact for Focused Industries, such as Pharmaceutical Ingredients. Since that time, she has expanded her role to include seven districts.
McIlvaine is currently co-chair of the IPEC-Americas Scientific Affairs committee, chair of the Good Distribution Practices (GDP) sub-committee, a part of the IPEC-Americas Good Manufacturing Practices (GMP) committee and has been an active member of IPEC-Americas since 2017.
McIlvaine has a bachelor of science (BS) degree in Environmental Science Ferrum College.