The Parenteral Drug Association (PDA), the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community, announced that 31 of its Training and Research Institute (TRI) courses are now listed with the US 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 US 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 US 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:
An Introduction to the Advanced Molecular Methods for Virus Detection
An Introduction to Visual Inspection
Aseptic Processing for Senior Management
Aseptic Processing Training Program
Biosimilars - Understanding the Challenges of Meeting 'Similarity'
CMC Regulatory Requirements in Drug Applications
Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods
Filters and Filtration in the Biopharmaceutical Industry – Basics Course
Filters and Filtration in the Biopharmaceutical Industry – Basics Course and Advanced Course
Filters and Filtration in the
Biopharmaceutical Industry – Advanced Course
Fundamentals of an Environmental Monitoring Program
Fundamentals of Aseptic Processing
Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing Facilities
Fundamentals of Lyophilization
Fundamentals of Lyophilization and Validation of Lyophilization
GMPs for Manufacturers of Sterile and/or Biotechnology Products
Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations
Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances
Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Packaging and Labeling of Drug Products
Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Pharmaceutical Drug Products
Investigating Microbial Data Deviations
Microbiological Quality of Raw Materials and Components
Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process
Preparation of Virus Spikes Used for Virus Clearance Studies and Virus Filtration
Quality Systems for Aseptic Processing
Risk-Based Qualification of Sterile Drug Product Manufacturing Systems
Single-Use Systems for the Manufacturing of Parenteral Products
Validation of Biotechnology-related Cleaning Processes
Validation of Dry Heat Processes Used for Depryogenation And Sterilization
Validation of Lyophilization
Virus Contamination in Biomanufacuring: Risk Mitigation, Preparedness and Response
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.
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