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Taking risks ICH Q9 (R1) quality risk management

Taking risks: ICH Q9 (R1) Quality Risk Management

Learn how to apply the key elements of pharmaceutical risk management, implement the ICH Q9 risk model in your business, and access tools for natural risk management integration. Join us to elevate your product lifecycle with effective risk assessment and control strategies.

How to Respond Effectively to Non-conformances Cited During Regulatory Inspections

How to Respond Effectively to Non-conformances Cited During Regulatory Inspections

Join our exclusive webinar and learn how to navigate regulatory authority inspections. Led by industry expert Charley Maxwell, this one-hour session will provide valuable insights into responding to non-conformances cited during inspections. Gain a clear understanding of expectations, timelines, and effective root cause analysis. Designed for senior management, quality professionals, and compliance heads, this webinar will equip you with the knowledge to address regulatory challenges and prioritize patient safety. Don’t miss this opportunity to ensure a successful outcome following inspections. Register now to secure your spot!

Setting up a Risk-Based Audit Program

Setting up a Risk-Based Audit Program: What to Consider and Why?

Gain in-depth knowledge of what to consider when setting up an audit program within a GDP or GMP environment, specifically about factoring in risk analysis methodologies. In addition to understanding ‘what’ is important, participants will understand precisely ‘why’ this is important, why we must consider the wider risk element and why reducing its overall impact is critical to its success.

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This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.

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