Subject: Regulatory

Beatrice Huey

Beatrice Huey is a Good Tissue Practice Specialist at the University of Arkansas for Medical Sciences in Little Rock, Arkansas. She has over 20 years of experience working in FDA-regulated environments and the tissue industry. She has extensive knowledge of current good tissue practice (CGTP), good manufacturing practices (CGMP), and good laboratory practice (GLP). She… Continue reading Beatrice Huey

Dr. Cecil W. Propst

Dr. Cecil W. Propst is Managing Director at Propst Consulting Services, a formulation and engineering support LLC located in Norton Shores, MI. He was the Director of R&D (Grand Haven site) at SPI Pharma until 2015. He served as Director of Quality Assurance and Technical Services at Fleming and Company and, before that, President of… Continue reading Dr. Cecil W. Propst

Stephen R. Schwartz

Stephen R. Schwartz is a consultant on claims support for Stephen Schwartz and Associates, as well as the founder and former President and CEO of IRSI, with over 50 years of experience in conducting claim support clinical trials. Mr. Schwartz has worked on some of the industry’s largest and most influential cosmetic launches over the… Continue reading Stephen R. Schwartz

Zeinab Schwen

Zeinab Schwen is an experienced technical expert, writer, lecturer, and entrepreneur with over 39 years in the pharmaceutical and medical device industries. While working for major pharmaceutical companies, Ms. Schwen gained hands-on experience in drug metabolism, drug development, and clinical trial management. She monitored large multicenter trials and participated in writing and preparing large drug… Continue reading Zeinab Schwen

J. Mark Wiggins

J. Mark Wiggins, B.S., M.S. is the Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years of experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck, with more than 15 years of experience submitting new and revised monographs to pharmacopeias, as well… Continue reading J. Mark Wiggins

Dr. Pardeep K. Gupta

Dr. Pardeep K. Gupta is a Professor of Pharmaceutics at the Philadelphia College of Pharmacy at the University of The Sciences in Philadelphia (USciences). He received his B. Pharm. and M. Pharm. (pharmaceutical chemistry) degrees from India. He also received a M.S. degree in medicinal chemistry from USciences and a Ph.D. in pharmaceutics from the… Continue reading Dr. Pardeep K. Gupta

David Long

David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years, where he gained considerable experience in all three Good Practice disciplines: GLP, GCP, and GMP. When he left Rhône-Poulenc, he was Senior Director of R&D worldwide for Quality and Process Improvement. Mr. Long has since worked for… Continue reading David Long

Jennifer R. Martin

Jennifer R. Martin is Director of Regulatory Affairs North America and Global Skin Health for the Colgate-Palmolive Company and a longtime regulatory affairs and product safety professional. She has more than 30 years of experience in analyzing legislation and regulation and applying it to assure product safety and compliance for cosmetics, drugs, medical devices, foods,… Continue reading Jennifer R. Martin

Shrinivas (Cheenu) Murti, Ph.D.

Shrinivas (Cheenu) Murti is Executive Director, Global Regulatory Affairs – CMC at Merck & Co., Kenilworth, NJ. He has a B.Pharm. from the University of Bombay, India, a Ph.D. in Pharmaceutical Sciences from the University of Missouri; and an MBA in General Management from Rutgers University. Prior to Merck, Cheenu worked at Organon and Schering-Plough,… Continue reading Shrinivas (Cheenu) Murti, Ph.D.

Charlie Neal

Charlie Neal, Jr. is Owner and Senior Consultant for Premier Quality Consulting, and has been in the pharmaceutical industry for over thirty-five years. He has a wealth of hands-on technical experience acquired from the chemical, drug, device, and pharmaceutical industries. His experience crosses into many areas of these industries, including research, development, process engineering, validation,… Continue reading Charlie Neal