ISPE Online Live Training Courses

ISPE Online Live Training Courses


Critical Utilities (T65)

Submitted by Anonymous on Tue, 11/08/2022 - 11:30
Date
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Online Live, United States
United States

Training Course
This course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”.

GAMP® 5, Annex 11/Part 11 Basic Principles

Submitted by Anonymous on Thu, 10/27/2022 - 12:30
Date
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Online Live, United States
United States

Training Course
This fundamental 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 provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. Please click the "Locations and Registrations" table to select the two or three-day sessions.

GAMP® 5 GxP Process Control (T21)

Submitted by Anonymous on Thu, 10/27/2022 - 12:30
Date
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Online Live, Belgium
Belgium

Training Course
This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records  may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.

GMP Fundamentals for the Pharmaceutical Industry

Submitted by Anonymous on Thu, 10/27/2022 - 12:30
Date
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Online Live, United States
United States

Training Course
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.

Overview of Biopharmaceutical Manufacturing Processes

Submitted by Anonymous on Thu, 10/27/2022 - 12:30
Date
-
Training Course
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins.

Storage Delivery and Qualification of Pharmaceutical Waters

Submitted by Anonymous on Fri, 10/28/2022 - 13:30
Date

Online Live, United States
United States

Training Course
This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.