Subject: QA/QC

David E. Wiggins

David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer. Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation,… Continue reading David E. Wiggins

J. Mark Wiggins

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… Continue reading J. Mark Wiggins

K A Narayanan

K A Narayanan is currently the vice-president, heading the new client initiatives for ACG. He brings to the table a rich experience of 30 years working with over 100 multi-national Pharma and FMCG giants delivering packaging solutions to make their products stand out.

Barry Friedman Ph.D

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department… Continue reading Barry Friedman Ph.D

Renée B. Galkin

Renée B. Galkin is a quality management consultant with over 30 years experience in the pharmaceutical and device industries. Prior to starting her consulting business, Ms. Galkin was part of two major companies: Science Management Corporation – a multinational consulting firm and then Wyeth/Pfizer where she gained her pharmaceutical experience during her 20 year association.… Continue reading Renée B. Galkin

Jan Gates

Jan Gates has 30+ years of experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed… Continue reading Jan Gates

Dr. Pardeep K. Gupta

Dr. Pardeep K. Gupta is a Professor of Pharmaceutics in 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 his Ph.D. in pharmaceutics from University of… Continue reading Dr. Pardeep K. Gupta

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

Joy McElroy

Joy McElroy, has 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies. Ms. McElroy specializes in… Continue reading Joy McElroy

Lucia Mokres

Dr. Lucia Mokres is a Biotechnology Entrepreneurial Consultant based in the Bay Area, specializing in helping early stage companies with novel technology gain traction and develop an investable technology and business model, and helping later stage companies work through regulatory and clinical challenges. Prior to establishing her consultancy, she was the Chief Medical Officer of… Continue reading Lucia Mokres