Pharmaceutical Quality System (PQS)

🚀 Pharmaceutical Quality System (PQS) & Beyond: A Comprehensive Training Course 🏫

Welcome to the Pharmaceutical Quality System (PQS) course, where we delve into the critical aspects of product quality review, change management, deviation and CAPA, out-of-specification/out-of-trend (OOS/OOT), and much more. This 7-section training program is designed to equip you with the knowledge and skills necessary to navigate the complex landscape of pharmaceutical quality systems as per the latest ICH Q10, ISO, EUGMP guidelines, and beyond.

🎓 Course Structure Overview 📚

Section 1: Crafting Your Pharmaceutical Training Strategy 🎫

• We begin by understanding the training requirements for pharmaceuticals and establish a robust strategy to meet these needs.

Section 2: Mastering Product Quality Review (PQR) 🔍

• Gain insights into the expectations of different regulatory bodies such as FDA, WHO, EUGMP, etc., regarding PQR.
• Dive into the key elements of PQR and learn how statistical evaluations play a pivotal role.
• Explore the differences in expectations between EU and FDA regulations.
• Discover common non-conformances in PQR and how to address them.
• Engage in an interactive Q&A session for a deeper understanding of PQR requirements.

Section 3: Navigating the Pharmaceutical Quality System (PQS) 🏗️

• Unravel the complexities of ICH Q10 and learn about its objectives, life cycle approach, and management responsibilities.
• Understand the core elements of PQS and how they contribute to quality assurance.
• Clarify key requirements through a dedicated Q&A session on PQS.

Section 4: Change Management System (Change Control) 🔄

• Understand the importance of change control within pharmaceutical industries and align with regulatory expectations from EU, FDA, ICH, PIC/S, ISO, etc.
• Explore the PDCA cycle's role in change controls and learn about the life cycle approach.
• Discover how AI can revolutionize change control processes and understand cGXP implications.
• Identify common oversights in change control, as indicated by FDA citations.

Section 5: Deviation Management - Turning Challenges into Opportunities 🚦

• Learn about regulatory expectations for deviations and master the scientific categorization of deviations using a simplified risk assessment tool.
• Understand how to effectively document and communicate deviations, and identify trends for continuous improvement.

Section 6: Out-of-Specification (OOS) and Out-of-Trend (OOT) Management 📈

• Grasp the regulatory requirements for OOS/OOT situations and learn about FDA citations.
• Understand the importance of resampling, retesting, outlier tests, and the implications of OOT.

Section 7: Corrective and Preventive Actions (CAPA) - The Poka Yoke Philosophy 🛡️

• Explore the guidelines for CAPA and understand some FDA citations.
• Learn the terminology of CAPA, differentiate between corrective and preventive actions, and apply the principles of Poka Yoke for mistake-proofing processes.
• Gain insights into the benefits of Poka Yoke and explore real-world examples to see the philosophy in action within pharmaceutical settings.

📅 Why You Should Enroll Today ✨

• Stay ahead of industry changes with up-to-date content reflecting the latest guidelines and best practices.
• Engage with a community of peers and professionals through interactive discussions and learning opportunities.
• Apply what you learn to real-world scenarios, enhancing your practical skills and knowledge.

🚀 Embark on Your Quality Journey 🌟 Are you ready to elevate your understanding of pharmaceutical quality systems? Enroll in the Pharmaceutical Quality System (PQS) course now and transform your approach to product quality, change management, and quality assurance. Don't miss this opportunity to become a quality champion in the dynamic world of pharmaceuticals! 🎓✨