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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 Packaging and Labeling

** Permanently Retired Due to Lack of Enrollment **

 

This highly interactive online course reviews the Packaging and Labeling...

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

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USFDA GMP Inspection Approach for Materials Systems

** Permanently Retired Due to Lack of Enrollment **

 

This highly interactive pre-recorded online course reviews the Productio...

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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Industry Overview: Drug Dosage Forms

** Permanently Retired Due to Lack of Enrollment **

 

This interactive online course reviews the key industry segments for che...

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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Product Quality Lifecycle Implementation® (PQLI®) 101: Visio

** Permanently Retired Due to Lack of Enrollment **

 

This course provides the background for the origins of the ICH guideline...

Member Price: $ 49.00 / € 0.00
Non-Member Price: $ 149.00 / € 110.00

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Life After GAMP 5: What Comes Next?

** Permanently Retired Due to Lack of Enrollment **

 

GAMP 5 was published in 2008 to great acclaim around the world. Just hav...

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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Manufacturing Execution Systems (MES) Good Practice Guide: A

** Permanently Retired Due to Lack of Enrollment **

 

Industry professionals David Lerner & Justin Iovino, senior members ...

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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Introduction to the Water and Steam Systems Baseline Guide P

** Permanently Retired Due to Lack of Enrollment **

 

This course provides a look at new information in the Water and Steam Sy...

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

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