course instructor
J. Mark Wiggins
B.S., M.S.
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, 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. He 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 R&D, and in the synthesis and characterization of active pharmaceutical ingredients for use in the treatment of HIV/AIDS, cancer, diabetes, hypercholesterolemia, and depression. Mark has been an active participant in pharmaceutical industry associations in the US and abroad and represented PhRMA on the ICH Q4B activities to harmonize general chapters in the pharmacopoeias. He has been an invited speaker at international meetings in the US, UK, Europe, India, Japan, Korea, and China, including the Ph. Eur. workshop "Quality of Medicines in a Globalized World. Mark holds a B.S. and M.S. degrees in Chemistry from Trinity University and the University of Wisconsin.
Joseph A. Albanese, Ph.D.
Managing Director of Albanese Consulting, LLC
Joe Albanese, Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) where he held positions in R&D, Supply Chain, and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As part of his duties, he was responsible for the compendial vigilance process for all Janssen products ensuring compliance with all major global and national pharmacopoeias. He actively served in industry working groups such as the PhRMA Limited Duration Key Issues Team for compendial issues with USP, the EFPIA Biotherapeutics subteam for the elaboration of biotherapeutic compendial standards, and was a member of the USP General Notices Project Team. He is currently active in the industry trade organizations NJPQCA, Midwest Compendial Discussion group and PDA that influence global health and compendial authorities. He recently co-authored a comprehensive 12-part series of articles, with J. Mark Wiggins, on compendial compliance that were published in Pharmaceutical Technology and BioPharm International.