PDA Training and Research Institute Adds 31 Courses to GSA Schedule 24 July, 2014

Bethesda, Md., July 24, 2014 – 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.

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 the
    Biopharmaceutical 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 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.