Good Manufacturing Practices – What you’ll need to get a job.
September 11–13, 2012 or November 6–8, 2012
Through lectures and role-playing exercises, the Good Manufacturing Practices course will allow you to experience firsthand what is expected of professionals who work in the U.S. pharmaceutical industry. This course condenses into three days what a new employee would typically experience during an extended orientation program. You’ll learn the language and culture of the pharmaceutical industry, giving you an advantage over other job candidates in the future. This course is taught by health care industry specialists who have worked at every level of business — from entry level scientist to president.
General Course Objectives
- Understand the terms safe, pure, and effective as they apply to pharmaceuticals
- Understand the role of the Food and Drug Administration (FDA) as a drug regulatory agency
- Understand the FDA’s drug approval process
- Understand what Good Manufacturing Practices are and how they apply to every drug dosage form from aspirin to sterile injectables
- Learn how to professionally interact with a FDA representatives during a site inspection
Major Topics Presented
- Pharmaceutical manufacturing facilities (factories); Processes and people (job functions)
- When is a drug considered safe, pure, and effective? Is there such a thing as a perfect drug?
- Physical, chemical, and microbiological testing requirements
- Education requirements for various pharmaceutical-related jobs
- How the FDA operates and interacts with the pharmaceutical industry
Although the overall goal of the course is to prepare individuals who are interested in a pharmaceutical career, Good Manufacturing Practices are also applicable to the following industries:
- Pharmaceutical active ingredients
- Medical devices
- In vitro diagnostic reagents and equipment
- Food processing