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

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

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

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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 / € 349.00
Non-Member Price: $ 1195.00 / € 399.00

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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 / € 349.00
Non-Member Price: $ 1275.00 / € 399.00

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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 / € 349.00
Non-Member Price: $ 800.00 / € 399.00

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2021 ISPE Best of Pharma Series: Quality & Regulatory

2021 ISPE Best of Pharma Series: Quality & Regulatory

Best & Brightest Aseptic Content from the 2021 Conferences

78 Pr...

Member Price: $ 199.00 / € 0.00
Non-Member Price: $ 299.00 / € 0.00

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2021 ISPE Best of Pharma Series: Pandemic

ISPE Best of Pharma Series: Pandemic

Best & Brightest Aseptic Content from the 2021 Conferences

18 Presentations Featuring...

Member Price: $ 199.00 / € 0.00
Non-Member Price: $ 299.00 / € 0.00

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2021 ISPE Best of Pharma Series: ATMP & Biotechnology

ISPE Best of Pharma Series: ATMP & Biotechnology

Best & Brightest ATMP & Biotechnology Content from the 2021 Conferences

Member Price: $ 199.00 / € 0.00
Non-Member Price: $ 299.00 / € 0.00

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2021 ISPE Best of Pharma Series: Aseptic

ISPE Best of Pharma Series: Aseptic

Best & Brightest Aseptic Content from the 2021 Conferences

33 Presentations Featu...

Member Price: $ 199.00 / € 0.00
Non-Member Price: $ 299.00 / € 0.00

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Facilities and Equipment: Commissioning and Qualifications a

This course provides an overview of success factors for Commissioning and Qualification projects. It examines key planning steps at the program lev...

Member Price: $ 250.00 / € 195.00
Non-Member Price: $ 480.00 / € 385.00

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Facilities and Equipment: Commissioning and Qualifications a

This course provides an overview of success factors for Commissioning and Qualification projects. It examines key planning steps at the program lev...

Member Price: $ 250.00 / € 195.00
Non-Member Price: $ 480.00 / € 385.00

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Cloud Concepts - Cyber Security and Blockchain

The cloud is the future and the future is now. But is the cloud a safe place for pharmaceutical companies to operate?...

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

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Asset Information Lifecycle Modelling
** Permanently Retired Due to Lack of Enrollment **
Member Price: $ 49.00 / € 40.00
Non-Member Price: $ 149.00 / € 110.00

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Adaptive Mobile BioPharma Production Suite: Case Study
This is a self-paced, pre-recorded webinar that includes a downloadable presentation for note-taking.

Approximate Course Duration
Member Price: $ 49.00 / € 40.00
Non-Member Price: $ 149.00 / € 122.00

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Virtual Discovery Stage
...
Member Price: $ 15000.00 /
Non-Member Price: $ 15000.00 /

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

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