** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

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

** Permanently Retired Due to Lack of Enrollment **

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

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

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

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

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...

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

** Permanently Retired Due to Lack of Enrollment **

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

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

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

** Permanently Retired Due to Lack of Enrollment **

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

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