Subject: Compliance

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

Bonnie M. Pappacena

Bonnie Pappacena is the President of Qualture LLC, a quality consulting firm committed to building quality into company culture. Ms. Pappacena has been a quality professional for over 35 years, spanning the animal health, biological, chemical, device, generic, and pharmaceutical industries. She possesses hands-on experience conducting and managing audits in GCP, GLP, GMP (clinical supplies… Continue reading Bonnie M. Pappacena

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

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.

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

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 EpiBiome, Inc.,… Continue reading Lucia Mokres

Joseph A. Albanese, Ph.D.

Joe Albanese is Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years of experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson & Johnson), where he held positions in R&D, Supply Chain, and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As… Continue reading Joseph A. Albanese, Ph.D.

Burton A. Amernick

Burton A. Amernick is a senior partner in the law firm of Polsinelli LLC, a General Practice National AM LAW 100 law firm, where he specializes in patent and trademark causes. In 2020, US News and World Report in their Best Law Firm Listing ranked Polsinelli LLC in Tier One for Patent Law. He was… Continue reading Burton A. Amernick

Frank Carroll

Frank Carroll is the Director of Supply Chain and Facilities for Zosano Pharma/ZP Group LLC in Fremont, CA. He has over 25 years of experience in the pharmaceutical, device, biologics, and biotech industries in many aspects of operations, including manufacturing, purchasing, materials management, strategic alliance management, implementation of advanced project management and MRP/ERP systems, and… Continue reading Frank Carroll