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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 / € 135.00
Non-Member Price: $ 460.00 / € 418.00

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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 / € 0.00
Non-Member Price: $ 0.00 / € 0.00

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Expert Xchange: Risk Based Decision Making: Advancing the In

Expert Xchange: Risk Based Decision Making: Advancing the Integration of QRM & KM...

Member Price: $ 0.00 / € 0.00
Non-Member Price: $ 0.00 / € 0.00

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Complying with Part 11 - Risk Management

The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the Europe...

Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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Complying with Part 11 - Risk Management

The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the Europe...

Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

add to your shopping cart

The ISPE Quality Metrics Initiative

** Permanently Retired Due to Lack of Enrollment **

 

Why is the Quality Metrics Initiative so important? What are the latest ...

Member Price: $ 49.00 / € 40.00
Non-Member Price: $ 149.00 / € 110.00

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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 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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Operationalizing a Quality Metrics Program: Critical Success
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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Maintenance: Reliability, Engineering and Asset Management

Do you have a framework for a risk-based approach for maintenance systems or component best practices?

Maintenance programs have long been ...

Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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Maintenance: Reliability, Engineering and Asset Management
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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Good Engineering Practice: Risk and Cost Management, Organiz

Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part ...

Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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Good Engineering Practice: Risk and Cost Management, Organiz

Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part ...

Member Price: $ 400.00 / € 365.00
Non-Member Price: $ 500.00 / € 440.00

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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 / € 70.00
Non-Member Price: $ 149.00 / € 110.00

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Computerized Systems Inspections in the Pharmaceutical Indus
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 79.00 / € 65.00
Non-Member Price: $ 149.00 / € 122.00

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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 / € 70.00
Non-Member Price: $ 149.00 / € 110.00

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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 / € 70.00
Non-Member Price: $ 149.00 / € 110.00

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The ISPE Drug Shortages Initiative

** Permanently Retired Due to Lack of Enrollment **

 

The prevention of drug shortages is critically important to public healt...

Member Price: $ 49.00 / € 40.00
Non-Member Price: $ 149.00 / € 110.00

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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 / € 328.00
Non-Member Price: $ 500.00 / € 410.00

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Clinical Trial Materials
This self-paced, pre-recorded course includes a downable presentation for note-taking, engaging graphics, links to regulatory information, assessments...
Member Price: $ 600.00 / € 492.00
Non-Member Price: $ 700.00 / € 574.00

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Containment Fundamentals

This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and...

Member Price: $ 300.00 / € 235.00
Non-Member Price: $ 400.00 / € 310.00

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Containment Fundamentals

This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and...

Member Price: $ 300.00 / € 235.00
Non-Member Price: $ 400.00 / € 310.00

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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 / € 492.00
Non-Member Price: $ 700.00 / € 574.00

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Calibration Management: A Robust, Cost Effective Approach U

Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure succes...

Member Price: $ 700.00 / € 540.00
Non-Member Price: $ 800.00 / € 620.00

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Calibration Management: A Robust, Cost Effective Approach U

Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure succes...

Member Price: $ 700.00 / € 540.00
Non-Member Price: $ 800.00 / € 620.00

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Biotech Basics: Fundamental Principles of the Biotechnology

This course will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants w...

Member Price: $ 300.00 / € 235.00
Non-Member Price: $ 400.00 / € 310.00

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