Course Description

APIs & Excipients—A Global Regulatory Overview

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Course ID 2772

In-Person Course

Who Should Attend?
This accredited, 4-hour training course will be valuable to pharmaceutical companies and excipient makers/distributors – regulatory affairs professionals and other interested parties who want to know more about the similarities and differences between Active Pharmaceutical Ingredients (APIs) and excipients in regions outside the US. Although there are no prerequisites, participants should possess a general basic knowledge of pharmaceutical ingredients and industry terminology.

Course Description
Regulations for Active Pharmaceutical Ingredients (APIs) and Excipient ingredients in drug products in some parts of the world are often not well known or can be confusing. Some countries do not differentiate the ingredients from the drug product (DP), others may have regulations specific to them.

This 4 hour, accredited webinar delivered over 2 days at 2 hours per day, will provide an overview of regulatory requirements and processes, and in some cases, the challenges they bring, for excipients and APIs in regions outside the US such as Canada, the EU, China, India, Japan, Latin America (Brazil, Argentina, Mexico), Korea and Taiwan.

Co-sponsored by IPEC-Americas

and The Center for Professional Advancement (CfPA); partners in training and education (T&E)

Course Director
Richard G. Einig, Ph.D., RAC, CQA; Pharmaceutical Quality Assurance Consultant; CfPA

Richard G. Einig is a consultant specializing in the pharmaceutical and veterinary medicine industries. His experience spans over twenty years in senior management of quality, regulatory, and development units of large international companies and start-up “biotechs”. He has worked internationally with innovator and generic dosage form companies, medical device manufacturers and research organizations. Dr. Einig participated in developing the PhRMA Bulk Pharmaceutical Committee’s Guidance on Production of Drug Substance, and is an invited speaker at domestic and international meetings on quality and processing of pharmaceutical products. Dr. Einig is a member of the American Chemical Society as well as a member and carries certifications from the American Society for Quality, the Regulatory Affairs Professional Society, and the Institute for Independent Business. He received undergraduate and graduate degrees in Chemistry from St. Louis University, MBA from Webster University, and Ph.D. from Missouri University.

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Course Director
Priscilla Zawislak; Global Regulatory Affairs Advocacy Manager; The Dow Chemical Company

Ms. Zawislak has over 30 years’ experience in Regulatory Affairs and Quality functions. Currently with The Dow Chemical Company, Ms. Zawislak is the Global Regulatory Affairs Advocacy Manager for Dow’s Food, Pharma and Medical Solutions business. Ms. Zawislak is the current Chair of IPEC-Americas and has been an active member of IPEC Americas committees since 2001 and is a member of the IPEC Americas Executive Committee. She is also the Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. Ms. Zawislak has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Ms. Zawislak earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.

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