GMP Fundamentals Bundle Series - Limited Offer

ISPE Online Live Training Courses

ISPE Online Live Training Courses


Submitted by Anonymous on
Overview of Biopharmaceutical Manufacturing Processes (T24)
Date
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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.
First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on
CAPA / RCA / Investigations Training Course (T73)
Date
-
Training Course
Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.
Submitted by Anonymous on
GAMP® 5, Annex 11/Part 11 Basic Principles (T45)
Date
-
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.
First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on
GAMP® Basic Principles 2-Day Training Course
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, by building upon existing industry good practice in an efficient and effective manner.
Submitted by Anonymous on
ATMP Manufacturing (T64)
Date
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Online Live, United States
United States

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.
Submitted by Anonymous on
Process Validation (T46)
Date
-
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.
Submitted by Anonymous on
Pharmaceutical Technology Transfer (T19)
Date
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Online Live, United States
United States

Training Course
This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.
Submitted by Anonymous on
Biopharmaceuticals: C&GT and ATMP (T68)
Date
-
Training Course
This instructor lead course is an advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C&GT products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell platforms are presented as the two most common and established therapeutic technologies for Gene Therapy and Cell Therapy, respectively. The purpose of this course it to provide a fundamental understanding of the CMC considerations for C&GT products.
Submitted by Anonymous on
Science and Risk-based C&Q (T40)
Date
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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.
Submitted by Anonymous on
Pharmaceutical Water Generation (T04)
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.