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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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ICH Q9 Quality Risk Management

** Permanently Retired Due to Lack of Enrollment **

 

Right now the pharma industry needs quality risk management (QRM) advice...

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

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Delivering Manufacturing Projects in a Risk-based World: The

** Permanently Retired Due to Lack of Enrollment **

 

The new FDA Guidance for Industry on Process Validation states that &ldq...

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

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Science and Risk Based C&Q Approach (Recorded)

** Permanently Retired Due to Lack of Enrollment **

 

This presentation discusses the challenges and benefits of applying a sc...

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

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Understanding Process Validation in Biotechnology Manufactur

US FDA’s Draft 2008 Process Validation Guidelines provide and excellent framework for understanding Process Validation. They describe the pri...

Member Price: $ 99.00 / € 70.00
Non-Member Price: $ 149.00 / € 110.00

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Biopharmaceutical Manufacturing Processes

** Permanently Retired Due to Lack of Enrollment **

 

This online course is an introduction to the processes used to manufactu...

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

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USFDA GMP Inspection Approach for Quality Systems

This highly-interactive, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the r...

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

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USFDA GMP Inspection Approach for Production Systems

This highly interactive pre-recorded online course reviews the Production System and its importance within the USFDA Systems Inspection Approach. T...

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

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USFDA GMP Inspection Approach for Laboratory Control Systems

This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Ap...

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

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Product Quality Lifecycle Implementation (PQLI®): Focusing o

** Permanently Retired Due to Lack of Enrollment **

 

Topics that are new to PQLI will be introduced as the project expands to...

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

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Introduction to Process Analytical Technology
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 0.00 / € 0.00
Non-Member Price: $ 149.00 / € 122.00

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ICH Q11: Development and Manufacture of Drug Substances Stat

** Permanently Retired Due to Lack of Enrollment **

 

ICH Q11 has been an industry hot topic for years, and now the guideline ...

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

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HVAC and Utilities: Special Requirements

** Permanently Retired Due to Lack of Enrollment **

 

Understand - utility requirements and system capacity evaluation - how t...

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

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HVAC: Practical Guidance for GMP Facilities

Good operational practices may be the key to good cGMP operations. A poor facility design can weaken even the best operations. In this webinar, lea...

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

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A GAMP Interpretation - Annex 11

** Permanently Retired Due to Lack of Enrollment **

 

A detailed and comprehensive GAMP interpretation of the new revised EU G...

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

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GAMP® 5 Series: IT Infrastructure Compliance and Control

** Permanently Retired Due to Lack of Enrollment **

 

How do you apply the new risk-based approach to IT infrastructure? Wheth...

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

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GAMP® 5: End-User Applications

** Permanently Retired Due to Lack of Enrollment **

 

Ever wonder whether your spreadsheet or other desktop application requir...

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

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GAMP® 5 Series: Changing the Industry

** Permanently Retired Due to Lack of Enrollment **

 

The pharmaceutical industry is responding to the challenge of significan...

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

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FDA Process Validation Guidance: A Review with Implications

** Permanently Retired Due to Lack of Enrollment **

 

A review of the recent changes in the FDA's thinking on lifecycle based ...

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

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Product Development: Technology Transfer
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 250.00 / € 205.00
Non-Member Price: $ 480.00 / € 394.00

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Regulatory Compliance: Standards, Practices, and Guides

** Permanently Retired Due to Lack of Enrollment **

 

Explore the role industry-generated guidance plays in relation to intern...

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

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Quality Systems: Risk Management and Quality Management Syst

Review the purpose, elements, and implementation of quality management systems, and risk management strategies. Highlights include a review of chan...

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

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Product Development: Production Scale-up and Optimization

Recap critical factors (i.e., rate change, mechanistic properties, equipment design) for scale-up, the impact on manufacturability, and options to ...

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

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Production Systems: Production Management

** Permanently Retired Due to Lack of Enrollment **

 

Review best practices for production management including storage requir...

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

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Production Systems: Production Control

Analyze batch records, contamination controls (cleaning, segregation, HVAC, etc.) and changeover. Gather details on critical factors that impact qu...

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

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Facilities and Equipment: Operation and Maintenance
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessm...
Member Price: $ 250.00 / € 205.00
Non-Member Price: $ 480.00 / € 394.00

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