Sterilization: Principles & Validation

September 23-25, 2019

The sterilization course covers the entire range of sterilization process utilized in the pharmaceutical, biotechnology and medical device industry. Sterilization methods, validation practices and related subjects to be covered include: prerequisites for sterilization, microbiology of sterilization, use of BIs, steam sterilization for porous loads, terminal sterilization using steam, steam sterilization-in-place, dry heat sterilization and depyrogenation; gas, liquid and vapor sterilization (including isolator decontamination); radiation sterilization; filtration sterilization for liquids; compendial and regulatory considerations.

Aseptic Processing: Compliance & Technology

September 26-27, 2019

The aseptic course will provide comprehensive coverage of aseptic processing reviewing
basic principles, technology choices, process design, environmental monitoring, and
process simulation. The course will includes sessions on aseptic processing risk
assessment, contemporary regulatory expectations and future technologies process. The
course materials and recommendations are wholly compatible with the regulatory
expectations of FDA’s 2004 Guideline on sterile drug products produced by aseptic
processing and EMA’s – Annex 1 on Sterile Medicinal Products.

Princeton, NJ

Chauncey Conference Center

660 Rosedale Road, Princeton, NJ 08541

Room reservation should be made directly with the hotel at 609-921-3600 or online at acc-chaunceyconferencecenter.com

James Agalloco

Jim is President of Agalloco&Associates, which provides a range of technical services to the pharmaceutical and biotechnology industry. Since the formation of Agalloco&Associates in 1991, Jim has assisted more than 200 pharmaceutical, biotechnology, medical device, equipment manufacturers and bulk pharmaceutical firms in a range of validation, sterilization, aseptic processing and compliance areas. Jim has more than 45 years of industrial experience. He was previously employed at Bristol-Myers Squibb, Pfizer and Merck. He has a BE and MS in Chemical Engineering and an MBA in Pharmaceutical Studies.
Jim is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a current member of USP’s Microbiology Expert Committee. He serves on the Editorial Advisory Boards of Pharmaceutical Technology and Pharmaceutical Manufacturing. Jim participates on the Scientific Advisory Boards of MEDInstill and Eniware.
He has authored or co-authored more than 40 book chapters, over 140 papers and has lectured extensively on process validation, aseptic processing, and sterilization. He is coeditor of “Validation of Pharmaceutical Processes”, 3rd edition and “Advanced Aseptic
Processing Technology.”

Russell Madsen

Russell is President of The Williamsburg Group, engaged in pharmaceutical consulting in the areas of CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, and regulatory liaison. Russel has over 45 years of experience in the pharmaceutical and related industries, including pharmaceutical manufacturing and quality control, medical devices, nutritional products, and consumer products. He has a B.S. and M.S. in Chemistry.

Prior to establishing TWG, Russ was employed by PDA, Bristol-Myers Squibb, Sterling Drug and Winthrop Laboratories. He is Vice-Chairman of ASTM Committee E55, a member of the USP Microbiology Expert Committee, Chairman of the USP Visual Inspection of Parenterals Expert Panel, a member of Pharmaceutical Technology’s Editorial Advisory Board, and an Honorary Member of PDA. He has published more than fifty scientific papers, books and book chapters and is co-editor of “Contamination Control in Healthcare Product Manufacturing.”