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The key to ISPE's success is without a doubt the passion of its Members. It's the volunteers, their keenness, and the passion for what they do. They're very professional, and yet it's a very friendly society.
Nigel Frost, Managing Director
Thermal Transfer, Ltd., United Kingdom
Watch the Video:
True Stories: What it means to be an ISPE Member - (WMV, 16 MB)
(Click to begin, or right-click to download and view later)
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Training |
Introduction to the US Pharmaceutical Industry (Includes On-line Essentials)
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Description
This course will provide participants with a basic, yet thorough, tutorial on the U.S. pharmaceutical industry, including finished pharmaceuticals, biologics, medical devices, veterinary products, and many others. Participants will receive an overview of the various aspects of technologies and products that make up the industry.
On-line Essentials Learning Objectives
Take Back to Your Job
- Examine regulatory issues related to current Good Manufacturing Practices (cGMPs)
- Define the roles and responsibilities of regulatory agencies
- Describe the U.S. pharmaceutical industry in a global economy
- Apply pharmaceutical, biotechnology, and medical device definitions
- Explain the drug development process
- Apply the licensing process of validation
- Discuss project life cycle definitions, project and industry economics, and operations
- Identify industry issues
- Define industry terminology
Attendance Suggested For
- Professionals who are new to the pharmaceutical industry and need a basic understanding
- Professionals in business operations who need to understand the drivers of this regulated industry
- Individuals who provide services or assistance to pharmaceutical companies to locate, design, construct, validate, and finance facilities
- Individuals who support the pharmaceutical industry through training, marketing, economic development, and personnel placement
- Any individuals wishing to gain a working knowledge of the pharmaceutical industry and how it operates
Continuing Education Units
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.
About On-line Essentials
This course includes On-line Essentials, a pre-recorded, Web-based session that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the On-line Essential two weeks prior to the start of the training event.
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