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Course Description

The aseptic course will provide comprehensive coverage of aseptic processing reviewing basic principles, technology choices, process design, environmental monitoring, and process simulation. The core technology of sterilizing filtration will be covered in depth. The last day of the course will address aseptic processing risk management, contemporary regulatory expectations and future technologies process. The course will draw upon FDA’s 2004 Guideline on Sterile Drug Products Produced by Aseptic Processing and EMA’s – Annex 1 on Sterile Medicinal Products. There will be ample time for interactive discussion among the students and instructors on the topics being presented.

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 and gases; Emerging sterilization methods; US and EU Compendia and Regulatory Considerations.

Both courses can be taken in the same week for a discounted fee.

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.

Dr. Klaus Haberer is Chief Scientific Officer of Compliance Advice & Services in Microbiology. Dr. Haberer has almost 40 years of professional experience in industry and academia in the area of microbiology. Prior to founding Compliance in 1999, Klaus was employed by Hoffmann-La Roche, and Hoechst AG (later Marion Roussel). He has served on Ph. Eur’s – Expert Group 1 Microbiology since 1986 is a member of PDA’s Science Advisory Board. He lectures and publishes frequently in the areas of sterilization, microbiology and aseptic processing.

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 is a member of USP’s Microbiology Expert Committee for 2010-2015, a member of Pharmaceutical Technology’s US Editorial Advisory Board, and PDA’s Science Advisory Board.

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