ISPE Online Live Training Courses

ISPE Online Live Training Courses


Process Validation

Submitted by Anonymous on Mon, 05/08/2023 - 18:00
Date
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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.

Turning QbD into a Practical Reality (T43)

Submitted by Anonymous on Mon, 07/03/2023 - 14:00
Date
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Online Live, United States
United States

Training Course
Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.

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.

ATMP Manufacturing (T64)

First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Fri, 09/01/2023 - 09:25
Date
-
Training Course
This course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide.

GAMP® 5, Annex 11/Part 11 Basic Principles (T45)

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

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.

Pharmaceutical Water Systems (T35)

Submitted by Anonymous on Fri, 10/28/2022 - 15:30
Date
-
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® Data Integrity 21 CFR Part 11 (T50)

Submitted by Anonymous on Fri, 07/14/2023 - 14:00
Date
-

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.

Science and Risk-based C&Q (T40)

First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Thu, 08/31/2023 - 14:44
Date
-

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® 5, Annex 11/Part 11 Basic Principles

Submitted by Anonymous on Fri, 07/14/2023 - 14:00
Date
-

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.