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Course Description

The sterilization course covers the entire range of sterilization processes utilized in the pharmaceutical, biotechnology and medical device industries. Sterilization methods, validation practices and related subjects to be covered include: Prerequisites for Sterilization; Microbiology of Sterilization; Use of Biological Indicators; 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; Compendia and Regulatory Considerations.

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.

Take either course or combine them for comprehensive training.

Who Should Attend

These courses are intended for individuals working with sterilization and/or aseptic processing. Those experienced with these technologies will refine their knowledge of the subjects through interaction with industry experts. Those without a strong background will learn the basics and develop an understanding of the more advanced considerations. The course is appropriate for personnel working in QA/QC, regulatory affairs, R&D, production, engineering, validation, and microbiology.

Your Instructors

James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Jim has nearly 40 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. He is a member of USP’s Microbiology Expert Committee for 2010-2015. He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.

Russell Madsen 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. Prior to establishing TWG, Russ was employed by PDA, Bristol-Myers Squibb, Sterling Drug and Winthrop Laboratories. He has been a member of several USP’s Expert Committee since 2005, a member of Pharmaceutical Technology’s Editorial Advisory Board, and PDA’s Science Advisory Board.

Gautam Maitra is Head of Regulatory and External Affairs at AC Immune SA. Guatam holds a Fil. Lic. in Chemistry from Stockholm University. Gautam also served as the European Director of one of the Parenteral Drug Association where he developed strong relationships with major health authorities: FDA, EMA, BfArM, ANSM, MPA, MHRA, Swissmedic etc. and other bodies: ICH, EFPIA, WHO, PIC/S. He has been an invited attendee to the annual USP European Stakeholder Forums. He has also been a member of the Bio- Manufacturing Working Group of the EFPIA/EBE in Brussels and a member of the PDA Task Force for early Phase Clinical Trials material. He serves on the Board of Directors of the Regulatory Affairs Professional Society (2013-15) and the President of the RAPS Swiss Affiliate. He is the President of the Geneva-based Swiss India Business Forum.

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