GMPs

Training
This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.
On Demand
After a history of tragic events that affected public safety, the current Good Manufacturing Practices (GMPs) were developed. GMPs are a set of regulations that uphold the Federal Food, Drug, and Cosmetic Act. It is important to look back at the history of these events, their effect on public health...
On Demand
The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the...
On Demand
To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work...
On Demand
This online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of...
On Demand
This course, the third in a four-part series, has been designed by ISPE and UL EduNeering, in cooperation with the Food and Drug Administration (FDA)/Office of Regulatory Affairs ORA, to assist FDA personnel in recognizing the critical aspects of computerized systems in the pharmaceutical industry...