OCTOBER 24-28, 2022 – SELLERSVILLE, PA – USA
Fedegari Group has collaborated with Jim Agalloco for decades. This partnership has allowed us to share experiences and knowledge with our colleagues and peers of the pharma industry, not only in the U.S., but worldwide.
For these reasons, Fedegari is pleased to introduce you the fall session of Agalloco & Associates training offerings.
The fall session is composed of two different courses::
Feel free to take the course that suits you most, but Fedegari suggests attending both!
These courses are intended for individuals working with sterilization, aseptic processing or process validation. Experienced individuals will refine their knowledge through interaction with industry experts. Those without a strong background will learn the basics and develop an understanding of the more advanced considerations. The courses are appropriate for personnel working in QA/QC, regulatory affairs, R&D, production, engineering, process development, validation and microbiology.
October 24 – 28, 2022
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; compendium and regulatory considerations.
October 24 – 28, 2022
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.
1228 Bethlehem Pike
Sellersville, PA, 18960
Sellersville is 90 minutes from Princeton and is served by the Philadelphia and Newark International Airports. There are many hotels within a 15-20 minute radius of the facility.
Attendees are responsible for their own accommodations.
Jim is President of Agalloco & Associates, which provides a wide 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, and bulk pharmaceutical firms, plus equipment manufacturers in 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. He is known for being a past President of the Parenteral Drug Association and also served as an Officer of the organization from 1982 to 1993. He is a current member of USP’s Microbiology Expert Committee and 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 and co-authored more than 40 book chapters, over 140 papers, and has lectured extensively on process validation, aseptic processing, and sterilization. He is the co-editor of “Validation of Pharmaceutical Processes – 3rd Edition”and the “Advanced Aseptic Processing Technology.” We are highly esteemed to welcome Jim back to our facility.
Russell Madsen holds a Bachelor of Science degree from St. Lawrence University and a Master of Science degree from Rensselaer Polytechnic Institute.
He was President of The Williamsburg Group, LLC, a pharmaceutical consulting firm focused on quality systems, aseptic processing, and sterilization located in Gaithersburg, Maryland. Prior to forming The Williamsburg Group, he had served as Acting President for the Parental Drug Association and was also elected Senior VP of Science and Technology for the organization. Before joining PDA, he was employed by Bristol-Myers Squibb as Director of Technical Services, providing technical and general consulting services to Bristol-Myers Squibb operations, worldwide.
He is a member of the Executive Committee of ASTM E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, a member of the USP Microbiology Expert Committee, a member of Pharmaceutical Technology’s Editorial Advisory Board, and an Honorary Member of PDA. Russell has also authored and co-authored over 90 publications and is co-editor of “Contamination Control in Healthcare Product Manufacturing.”
We are pleased to welcome Russell to our facility.