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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: 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

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

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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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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: 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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Basic Principles of Computerized Systems Compliance: Applyin

This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tri...

Member Price: $ 700.00
Non-Member Price: $ 800.00

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Basic Principles of Computerized Systems Compliance: Applyin

This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tri...

Member Price: $ 700.00
Non-Member Price: $ 800.00

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Airflow Pattern Visualization (AFPV)

Airflow pattern visualization provides a visual record of actual airflow patterns in a pharmaceutical facility.  It is currently the most wide...

Member Price: $ 400.00
Non-Member Price: $ 500.00

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Biopharmaceutical Bundle: Bundle of 3 Courses

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

Member Price: $ 2300.00
Non-Member Price: $ 2500.00

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Biopharmaceuticals: C> and ATMP

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

Member Price: $ 1125.00
Non-Member Price: $ 1195.00

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Biopharmaceuticals: CMC Development

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

Member Price: $ 1200.00
Non-Member Price: $ 1275.00

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Biopharmaceuticals: Intro to Large Molecule Therapeutics

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

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

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