ISPE Online Live Training Courses

ISPE Online Live Training Courses


Overview of Biopharmaceutical Manufacturing Processes

Submitted by Anonymous on Thu, 10/27/2022 - 15:30
Date
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Online Live, United States
United States

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 Mon, 05/08/2023 - 18:00
Date
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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.

Pharmaceutical Water Generation (T04)

Submitted by Anonymous on Thu, 10/27/2022 - 15:30
Date
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Training Course
This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

Process Validation

Submitted by Anonymous on Mon, 05/08/2023 - 18:00
Date
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Online Live, United Kingdom
United Kingdom

Training Course
This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.

Science and Risk-based C&Q (T40)

Submitted by Anonymous on Thu, 10/27/2022 - 15:30
Date
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Online Live, United States
United States

Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

GAMP® Data Integrity 21 CFR Part 11 (T50)

Submitted by Anonymous on Fri, 10/28/2022 - 15:30
Date
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Online Live, United States
United States

Training Course
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.

Pharmaceutical Water Systems (T35)

Submitted by Anonymous on Fri, 10/28/2022 - 15:30
Date
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Online Live, Belgium
Belgium

Training Course
This 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 microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.

GAMP® 5, Annex 11/Part 11 Basic Principles

Submitted by Anonymous on Fri, 10/28/2022 - 15:30
Date
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Online Live, Belgium
Belgium

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.