All Virtual! 12 Contact hours, 4 teaching hrs. Per day, + 1/2 hour break each day
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IPEC-Members will receive an exstensive discount for the 3 1/2-day workshop.
Excipients often play a critical role in the manufacture of biopharmaceuticals and in the formulation of small molecule and biopharmaceutical products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States Pharmacopeia-National Formulary (USP-NF), states: “Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.”
This course is intended for those responsible for ensuring compliance of excipients with the pharmacopoeias and regulatory authorities and is applicable to pharmaceutical and excipient manufacturers and excipient distributors within the OTC, generic, innovator, biotechnology, consumer-care, and related industries. This course will benefit individuals in:
- Compendial affairs
- Regulatory affairs/CMC
- Quality assurance/Quality control
- Analytical chemistry
- R&D/product development/Formulation/Method development
- Product management/marketing
In addition, those individuals who perform analysis using Compendial standards would benefitnfrom a better understanding of how the different compendia are structured, revised and interface with GMP requirements.
Upon completion of this course, you will be able to:
- Describe the content, organization, and revision process of the major pharmacopoeias, including USP-NF, Europe (Ph.Eur.), Japan (JP), India (IP) and China (ChP)
- Identify the GMP quality system and compendial requirements for the manufacture of excipients
- Describe the regulatory expectations for approval of pharmaceutical excipient suppliers and the approval of incoming excipients
- Describe the role of pharmacopoeias in the global bio/pharmaceutical and excipient industries
- Describe the processes for compendial surveillance and take advantage of opportunities for influencing monograph and other compliance requirements
- Identify the customer and regulatory expectations for non-monograph excipients
Dr. Irwin B. Silverstein. Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.
J. Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck & Co., Inc., (known as MSD outside the US and Canada), with more than 15 years’ experience submitting new and revised monographs to pharmacopoeias, as well as reviewing and responding to proposed compendial changes from around the world. Mr. Wiggins also has experience in the testing and release of excipients for use in formulation design, scale-up, and clinical supplies in support of new product research and development, and in the synthesis and characterization of active pharmaceutical ingredients for use in the treatment of HIV/AIDS, cancer, diabetes, hypercholesterolemia, and depression.
Mr. Wiggins has been an active participant in pharmaceutical industry associations in the US, UK, Europe, Japan and China, and represented PhRMA on the ICH Q4B activities to harmonize general chapters in the pharmacopoeias. Mr. Wiggins has authored several papers, including an introduction to the concept of the "Ideal Pharmacopoeia", "Compendial Globalization", and the industry perspective on the pilot project to achieve “Prospective Harmonization” for API monographs. He has also co-authored a comprehensive series of twelve articles on pharmacopoeia compliance that have been published as on-line regulatory sourcebooks for the journals Pharmaceutical Technology and BioPharm International. He has been an invited speaker at international meetings and conferences on compendial harmonization, including the Ph. Eur. workshop "Quality of Medicines in a Globalized World", and more recently in discussions with the pharmacopoeias and regulators in the US, UK, Europe, India, Japan, Korea, and China. Mr. Wiggins holds B.S. and M.S. degrees in Chemistry from Trinity University and the University of Wisconsin, both in the US.