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.

Product Specifications

Course Duration: 45 Minutes


Principles of Aseptic Processing

Because microbiological and particulate contamination can potentially cause serious health problems in animals and humans, it is vital that sterile products be manufactured, filled, and packaged in an aseptic environment. This course will address the general principles and practices necessary to assure product sterility and safety related to aseptic processing. Topics in this course include: Cleanroom Requirements, The Process, Employee Practices, Validation, and Monitoring. After completing this course, learners will be able to recognize the general principles and practices necessary to ensure product sterility and safety, as well as the Good Manufacturing Practices (GMP) requirements for areas where aseptically produced products are handled.

Principles of Good Documentation

Documentation is an essential part of Good Manufacturing Practice (GMP). This course provides an overview for manufacturers of pharmaceutical and biological products of the documents required and the controls that should be in place. The regulatory requirements of FDA are addressed with reference also made to the requirements of the EU.The course provides an introduction to staff at all levels and highlights the personal responsibility they have for ensuring documentation is followed and documentation is correct.

Bloodborne Pathogens (BBP)

If your job duties include even occasional contact with blood or other infectious materials, you are at risk for contracting potentially deadly, incurable diseases. Take this course to learn what bloodborne pathogens are and how you can protect yourself from them. Ideal learners include anyone who may be exposed to blood or other potentially infectious materials, including healthcare workers, custodians, maintenance staff, research personnel and construction workers.