Subject: QA/QC

Karl F. Popp, R. Ph.D.

Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to the pharmaceutical, cosmetic, and allied industries. He is also a practicing retail pharmacist. During his career, he has been responsible for the development of products that have generated over $2 billion in sales. From 1989 to 2008, he was associated… Continue reading Karl F. Popp, R. Ph.D.

Dr. Gregory A. Sacha

Dr. Gregory A. Sacha is a Senior Research Scientist for Baxter BioPharma Solutions in Bloomington, IN. He received a BS in Pharmacy from Butler University in 1993 and earned a Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1999. Dr. Sacha specializes in the formulation of sterile solutions and lyophilized solids for large… Continue reading Dr. Gregory A. Sacha

Philip E. Sax

Phil Sax is an early thought leader for CSV (Computer System Validation).  He is a Founder and President of Weinberg Spelton and Sax, a computer system validation consultancy, and has been involved in hundreds of successful validation projects. He has trained more than 1000 professionals, including FDA staff, and has served as Vice President and… Continue reading Philip E. Sax

J. Jeff Schwegman, Ph.D.

J. Jeff Schwegman, Ph.D. is the founder and chief executive officer of AB BioTechnologies, where he manages the day to day operations of the company. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington, Indiana, where he gained experience in analytical, formulation, and process… Continue reading J. Jeff Schwegman, Ph.D.

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

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

Barry Friedman Ph.D.

Barry A. Friedman, Ph.D. is a Senior Consultant in the biotechnology, regulatory compliance, microbiology, and aseptic processing arenas. 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 of Quality Control, he managed a multi-shift… Continue reading Barry Friedman Ph.D.

Jan Gates

Jan Gates has 30+ years of experience in package engineering for foods, pharmaceuticals, detergents, and medical devices, with a BS in Food Science and an 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… Continue reading Jan Gates

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

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