Expert Insight: New guidelines and modern chromatographic solutions converge to ensure data quality in the pharmaceutical laboratory

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Heather Longden, Waters Corporation (top left), Dr. Horacio Pappa, US Pharmacopeia (top right), Dr. Phil Borman, GSK (bottom left) and James Pound, MHRA (bottom right)

Advancements in laboratory instruments and consumables continue to enable the improvement of analytical measurements. However, the post-approval regulatory burden to revalidate analytical procedures and amend global licenses can be significant, creating barriers to improved analytical procedures and enhanced data quality. New regulatory guidelines are emerging as proactive approaches to control risk, improve quality and alleviate these challenges.

In this upcoming SelectScience webinar, Waters experts will show the benefits of improved technology with robust, fit-for-purpose methods using the new Arc HPLC System. Examples will highlight enhancements that minimize day-to-day, instrument-to-instrument, and analyst-to-analyst variability, leading to greater confidence in data quality and ‘right first time’ data processing.

Highlighting new regulatory guidelines, Dr. Horacio Pappa, Director General Chapters of the United States Pharmacopeia, will present updates on: USP Chapter<1220> The Analytical Procedure Lifecycle; ICH Q2 guideline for validation; and the proposed ICH Q14 guidance on analytical procedure development.

The session will culminate in an expert panel discussion with Dr. Phil Borman, Senior Fellow and Product Quality Director at GSK, James Pound, Secretary & Scientific Director, British Pharmacopoeia Commission, Medicines and Healthcare products Regulatory Agency (MHRA), Dr. Pappa, and Heather Longden, Regulatory Expert at Waters, to discuss strategies for managing analytical procedure and technology improvements in the pharmaceutical laboratory within the context of new regulatory guidelines.

Key Learning Objectives:

• Benefits of the new Arc HPLC System
• Updates on USP Chapter <1220> The Analytical Procedure Lifecycle; ICH Q2 guideline for validation; and the proposed ICH Q14 guidance
• Strategies for managing analytical procedure and technology improvements in the pharmaceutical laboratory within the context of new regulatory guidelines

Who should attend:

• Pharmaceutical directors, managers, and analysts

This webinar will run on Wednesday, October 7, at:

• 16:00 BST
• 17:00 CEST
• 08:00 PDT
• 11:00 EDT

Register for this webinar here>>

SelectScience runs more than 10 webinars a month across various scientific topics, discover more of our webinars here>>