ISPE Online Live Training Courses

ISPE Online Live Training Courses


Overview of Biopharmaceutical Manufacturing Processes

Submitted by Anonymous on Wed, 01/19/2022 - 15:30
Date
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Online Live,
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.

Pharmaceutical Water Systems (T35)

Submitted by Anonymous on Wed, 01/19/2022 - 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.

ATMP Manufacturing (T64)

Submitted by Anonymous on Mon, 10/18/2021 - 15:30
Date
-
Training Course
This new 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

Submitted by Anonymous on Mon, 10/18/2021 - 15:30
Date
-

Online Live, %administrativeArea
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.

Biopharmaceuticals: CMC Aspects Training (T67)

Submitted by Anonymous on Wed, 01/19/2022 - 15:30
Date
-

Online Live,
United States

Training Course
This new instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.

Science and Risk-based C&Q (T40)

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

Online Live,
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 Thu, 10/27/2022 - 12:30
Date
-

Online Live,
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.

HVAC for Pharma Facilities

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

Online Live, %administrativeArea
Belgium

Training Course
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.