This DVD takes a retrospective look at the food and drug adulterations that led to the formation of the FDA and the evolution of its regulations. It summarizes the various historical events and impact of the media that led to the development of the laws and quality measures that currently exist. It also examines how the FDA has strengthened control with regulations and Good Manufacturing Practice (GMP). Included with GMP: Why Do We Need It? is a DVD containing the 1967 classic FDA presentation No Margin for Error. This film, produced to drive home the importance of the newly passed GMP regulations, presents a fictitious account of the drug Steroid 47. The drug becomes contaminated, threatening patients' lives due to mix-ups, errors, and lack of the controls required by GMP. Although No Margin for Error was made more than 30 years ago, the message is still relevant to all food, drug, medical device, and blood industries: we must operate our businesses in a state-of-control. After viewing GMP: Why Do We Need It?, you will have an understanding of the:

• History of food and drug inspections
• Formation and evolution of the FDA
• Importance of Good Manufacturing Practices
• Reasons for implementing FDA law and regulations

You will also understand the necessity for:

• Good planning
• Good process management
• Knowledgeable, productive people
• Product quality
• Consumer safety
• GMP lifestyle

Item #: GMP034
Run Time: 53:00