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Introduction to Process Validation - 4 Days - James Agalloco and Phil DeSantis
Provides an overview of all aspects of validation including utility systems, sterilization processes, computer systems, cleaning, production process (including BPC's, biotech, oral dosage forms and parenterals) validation, controlled environments, aseptic processing and isolation technology. This course is suited for individuals new to validation, with considerable validation experience or who work in related areas such as quality assurance, development, engineering or manufacturing.
Sterilization-in-Place - 1 Day - James Agalloco
Describes the design, operation and validation of systems for sterilization of process equipment (tanks, lyophilizers, fermentors, piping systems, etc.) in-situ. The emphasis in the course is on proper design of the system to insure proper sterilization and enhance sterility assurance. Particular attention is given to the sterilization of filtration systems
Intended for validation, manufacturing, quality assurance and engineering personnel.
Aseptic Processing Trends and Issues - 1 Day - James Agalloco
An overview of current regulation, guidelines, facility and system design concepts relating to aseptic processing. It reviews the evolution of process simulation testing, incorporating both regulatory guidance and industry perspectives. A focus of the program is a review of the essential elements of a media fill program. It includes a discussion of approaches to be used for the preparation of sterile bulk pharmaceutical chemicals. The course is intended for a quality assurance, microbiology, validation and manufacturing audience.
Sterilization: Processes & Validation - 3 Days - James Agalloco
Includes steam [overkill and bioburden] sterilization, dry heat sterilization and depyrogenation, gas, radiation and filtration sterilization. An overview of equipment aspects, and sterilization microbiology are all of the principal methods included. Intended for validation, production and quality assurance personnel.
Isolation Technology - 3 days - James Agalloco and James Akers of Akers Kennedy & Associates
Addresses aspects of isolation and barrier technology for sterility testing, aseptic filling, manufacturing and containment applications. Includes design, validation, operation, and regulatory elements. Intended for production, development, quality control / assurance and engineering personnel.
Master Planning & Management of Validation - 1 Day - James Agalloco
Reviews validation management activities for both new facilities and ongoing operations. Includes elements of validation useful in the organization of a corporate or site validation program. Intended for validation, quality assurance, engineering and regulatory affairs personnel.
Facility Design / Environmental Monitoring / Aseptic Processing - 2 Days - James Agalloco, James Akers and Phil DeSantis
Reviews all aspects of facility design development, establishment of environmental monitoring programs (initial and ongoing) and process simulation testing in facilities for the production of sterile drug products. The course is intended for a quality assurance, microbiology, validation and manufacturing audience.
Any of the courses described above can be modified to suit specific training needs. Course contents can be expanded or contracted as needed to suit the particular needs of the client. We are also able to provide training in other areas not mentioned through our associates. Please contact us if the course you desire is not listed above.
We have also worked with firms on more interactive workshop sessions in which the participants play a much larger role in the discussion of the subject material. These are useful in the definition of corporate or site practices in defined areas and are custom designed in cooperation with the client.
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