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PDA Training and Research Institute Adds 31 Courses to GSA Schedule

July 24, 2014

BETHESDA, Md., July 24, 2014 /PRNewswire-USNewswire/ — The Parenteral Drug Association (PDA) announced today that 31 of its Training and Research Institute (TRI) courses are now listed with the U.S. General Services Administration (GSA) under a Federal Supply Schedule contract.

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The 31 courses will be included on the GSA Advantage, GSA’s online shopping and ordering system https://www.gsaadvantage.gov/advantage/main/start_page.do). This will improve the visibility of these PDA TRI courses to federal officials and make it easier for them to participate. Over the years, PDA TRI has conducted numerous training courses specifically designed for officials at the U.S. Food and Drug Administration. In addition, FDA officials have participated in TRI’s regular course offerings.

“By adding 31 courses to the GSA Federal Supply Schedule, employees of the U.S. Federal Government will have an easier time participating in the unique, world class training courses in the PDA TRI facilities and lecture courses,” says PDA President Richard Johnson.

The courses are listed under Special Item Numbers (SINs) 874-4: Training Services. They are:

    1. An Introduction to the Advanced Molecular Methods for Virus Detection
    2. An Introduction to Visual Inspection
    3. Aseptic Processing for Senior Management
    4. Aseptic Processing Training Program
    5. Biosimilars - Understanding the Challenges of Meeting 'Similarity'
    6. CMC Regulatory Requirements in Drug Applications
    7. Evaluation, Validation and Implementation of Alternative and Rapid
       Microbiological Testing Methods
    8. Filters and Filtration in the Biopharmaceutical Industry - Basics Course
    9. Filters and Filtration in the Biopharmaceutical Industry - Basics Course
       and Advanced Course

    10. Filters and Filtration in theBiopharmaceutical Industry - Advanced
        Course
    11. Fundamentals of an Environmental Monitoring Program
    12. Fundamentals of Aseptic Processing
    13. Fundamentals of Cleaning and Disinfectant Programs for Aseptic
        Manufacturing Facilities
    14. Fundamentals of Lyophilization
    15. Fundamentals of Lyophilization and Validation of Lyophilization
    16. GMPs for Manufacturers of Sterile and/or Biotechnology Products
    17. Implementation of Quality Risk Management for Commercial Pharmaceutical
        and Biotechnology Manufacturing Operations
    18. Implementing Quality Risk Management for Pharmaceutical and
        Biotechnology Manufacturing Operations: Case Studies in the
        Manufacturing of Biotechnological Bulk Drug Substances
    19. Implementing Quality Risk Management for Pharmaceutical and
        Biotechnology Manufacturing Operations: Case Studies in the Packaging
        and Labeling of Drug Products
    20. Implementing Quality Risk Management for Pharmaceutical and
        Biotechnology Manufacturing Operations: Case Studies in the
        Manufacturing of Pharmaceutical Drug Products
    21. Investigating Microbial Data Deviations
    22. Microbiological Quality of Raw Materials and Components
    23. Microbiological Risk Assessment of a Pharmaceutical Manufacturing
        Process
    24. Preparation of Virus Spikes Used for Virus Clearance Studies and Virus
        Filtration
    25. Quality Systems for Aseptic Processing
    26. Risk-Based Qualification of Sterile Drug Product Manufacturing Systems
    27. Single-Use Systems for the Manufacturing of Parenteral Products
    28. Validation of Biotechnology-related Cleaning Processes
    29. Validation of Dry Heat Processes Used for Depryogenation And
        Sterilization
    30. Validation of Lyophilization
    31. Virus Contamination in Biomanufacuring: Risk Mitigation, Preparedness
        and Response

About PDA – Connecting People, Science and Regulation®

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.

About PDA Training and Research Institute

PDA Training and Research Institute (TRI) has established itself as the leading global provider of education, training and applied research opportunities in pharmaceutical sciences and associated technologies. TRI offers courses for professionals involved in developing and manufacturing quality pharmaceutical and biopharmaceutical products, targeting individuals employed in industry, government and academia worldwide. Located in Bethesda, Maryland, TRI is a unique, modern training facility. It features an aseptic processing suite including a fill room, gowning room, component prep lab, and a clean staging area. A microbiology lab, a biotechnology lab, a Clean-In-Place lab, and classrooms are also utilized in its laboratory training courses.

Media Inquiries: Walt Morris, 301-656-5900, x. 148; morris@pda.org

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SOURCE Parenteral Drug Association


Source: PR Newswire



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