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Guidance Document License Agreement

The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.

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ISPE DACH Affiliate: WFI Handbook Download

The ISPE D/A/C/H Affiliate Handbook: Production of Water for Injection without Distillation was first published by the ISPE Germany/Austria/Switzer...

Member Price: $ 149.00
Non-Member Price: $ 460.00

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ISPE Expert Xchange: Next Decade of Continuous Manufacturing

ISPE Expert Xchange: Next Decade of Continuous Manufacturing

Recording of the Expert Exchange Webinar originally presented June 1, 2022

...
Member Price: $ 0.00
Non-Member Price: $ 0.00

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ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

Recording of the Expert Exchange Webinar originally presented on June 9, 2022

...
Member Price: $ 199.00
Non-Member Price: $ 249.00

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ICH Q12: Considerations for Pharmaceutical Product Lifecycl

International Council for Harmonisation’s (ICH) guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product...

Member Price: $ 349.00
Non-Member Price: $ 399.00

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Oral Solid Dosage Forms
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 400.00
Non-Member Price: $ 500.00

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Implementation of ICH Q12
ICH Q12 - Considerations for Pharmaceutical Product Lifecycle Management

International Council fo...

Member Price: $ 349.00
Non-Member Price: $ 399.00

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GMP Fundamentals: Holding and Distribution

In this course, you will learn the requirements for storage, handling, and distribution of finished products to ensure that they are stored in ...

Member Price: $ 0.00
Non-Member Price: $ 0.00

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GMP Fundamentals: Packaging and Labeling Control

In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices....

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Production & Process Controls

This course offers an overview of Good Manufacturing Practices (GMP) for medicinal product production and process control. You will learn about...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Control of Excipients, Components and Drug

In this course, you will learn about the fundamentals and importance of GMP control in the pharmaceutical industry. Good Manufacturing Practice...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Equipment

This course will focus on the fundamentals and importance of GMP Equipment.

...
Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Buildings and Facilities

GMP Fundamentals: Buildings and Facilities

...
Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Quality System
GMP Fundamentals: Quality System

This course will focus on the fundamentals and importance of a GMP Quality...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Organization & Personnel

The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall ...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: An Introduction & History of Good Manufact

This course will focus on an introduction to History, Regulations, Product life-cycle, and development with an emphasis on the difference betwe...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Records and Reports

In this course, you will learn the various types of documentation and record-keeping practices used in the pharmaceutical industry, and how to ...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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GMP Fundamentals: Laboratory Controls

In this course, you will learn about the fundamental principles of laboratory controls in Good Manufacturing Practice (GMP). You will understand th...

Member Price: $ 45.00
Non-Member Price: $ 50.00

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Computerized Systems Inspections in the Medical Device Indus

** Permanently Retired Due to Lack of Enrollment **

 

This course has been designed to assist FDA inspectors in recognizing th...

Member Price: $ 79.00
Non-Member Price: $ 149.00

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Approach to Computerized Systems Validation and Compliance

This course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals,...

Member Price: $ 79.00
Non-Member Price: $ 149.00

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Requirements for Computerized Systems Validation and Complia

This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of compute...

Member Price: $ 99.00
Non-Member Price: $ 149.00

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Decommissioning
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 400.00
Non-Member Price: $ 500.00

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Cleaning Fundamentals for the Pharmaceutical Industry
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 600.00
Non-Member Price: $ 700.00

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Biofármacos: Aspectos CMC

Bem-vindo ao Biofarmacêuticos: Aspectos CMC. A ciência e a tecnologia de desenvolvimento e fabricação biofarmacêuti...

Member Price: $ 750.00
Non-Member Price: $ 800.00

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Biofármacos: Introdução às Grandes Moléculas

O curso se concentrará em aspectos de Introdução à Química, Manufatura e Controles (CMC) do desenvolvimento biof...

Member Price: $ 750.00
Non-Member Price: $ 800.00

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Biopharmaceuticals: Introduction to Large Molecules

The course will focus on an Introduction to Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development and a secondary em...

Member Price: $ 750.00
Non-Member Price: $ 800.00

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