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Life Science
UL PURE™ Learning has partnered with corporate and government clients in the Life Science, Health Care, Energy and General Industry markets for over 30 years.
We currently maintain more than 500 eLearning courses that are written and reviewed by recognized subject matter experts, including the USFDA. In fact, more than 1 million industry professionals, including over 36,000 FDA investigators, have completed over seven million courses since 2003. Courses are regularly updated to reflect the most current expectations and requirements of regulators and industry groups. Our global qualityand compliance management methodology has resulted in measurable performance and compliance improvements.
Our eLearning philosophyis based on Mastery Learning, which has been proven to improve retention and change behavior in adult learners through methods thatinclude interaction with dynamic content and built-in assessments.
Awareness of FDA Inspections for Pharmaceutical Manufacturers
This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95
Awareness of FDA Inspections for Pharmaceutical Manufacturers (Chinese)
This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95
Awareness of FDA Inspections for Pharmaceutical Manufacturers (French)
This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95
Awareness of FDA Inspections for Pharmaceutical Manufacturers (Japanese)
This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95
Awareness of FDA Inspections for Pharmaceutical Manufacturers (Spanish)
This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95
Orientation to GMP Compliance
Because FDA GMP regulations have a direct impact on how you do your job, you need insight on how they are applied and interpreted. This course illustrates how the Food, Drug, and Cosmetic Act is tied to Title 21 of the Code of Federal Regulations and how Good Manufacturing Practices (GMPs) are key elements in those regulations. Topics include key definitions, GMP focus areas, interpretation of GMPs, and enforcement actions. After completing this course, you will be able to recognize GMP regulations, basic GMP requirements, your roles and responsibilities for compliance, and the ways FDA enforces GMP regulations.
$99.95