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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...
This online course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It...
Published: October 2012 Pages: 160 Table of Contents Special Pricing for Emerging Economies Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, the ISPE GAMP® Good Practice Guide...
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...
This online course has been designed to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. This course explains how computerized systems are used in the medical device manufacturing...
Published: February 2008 Pages: 356 Table of Contents Table of Contents Supporting Materials Special Pricing for Emerging Economies Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems...
This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance...
Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T11)
This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired...
