USFDA GMP Inspection Approach for Laboratory Control Systems

This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. This online course introduces laboratory controls, breaks down GMP Part 211, reviews method validation and out of specification results, and provides tips for laboratory notebooks.

Cloud Concepts - Cyber Security and Block Chain

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 regulatory compliance will be explored and answers on how one can comply will be provided. If already operating in the cloud, attendees will be gain insight on how they can assess their own company's cloud platform, and take proactive measures to resolve any vulnerabilities.

Computerized Systems Inspections in the Pharmaceutical Industry

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 during Pre-Approval and routine current Good Manufacturing Practices cGMP inspections. The course explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these systems.
This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common....
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic....
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information....
The interactive course uses extensive exercises to provide an intense examination and interpretation of the cGMP regulations with special emphasis on....