Product Quality Review (Annual Product Quality Review)

🎓 Product Quality Review (Annual Product Quality Review) - Master the Essentials!

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Course Overview:

Discover the critical role of the annual Product Quality Review (PQR) in maintaining a robust Quality Management System within your organization. This comprehensive course, led by industry expert Hitendrakumar Shah, will guide you through the intricacies of quality assurance and help you master the PQR process as per regulatory requirements.

Module 1: Process Capability & Index

Dive deep into the concept of process capability and learn how to evaluate it effectively. This lecture is designed to give you a clear understanding of this core aspect of PQR, ensuring you can analyze and optimize your processes with confidence.

🔹 Key Takeaways:

• Grasp the fundamentals of process capability and index.
• Learn how these metrics are crucial for evaluating process performance during PQR.

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Module 2: Pharmaceutical Quality System

A detailed exploration awaits you in this module, where we will cover all the critical elements that make up a Pharmaceutical Quality System (PQS). This includes:

• Importance of the Topic and Agenda: Understand the significance of PQS in pharmaceutical quality management.
• Know Your Trainer: Get to know Hitendrakumar Shah, your course instructor, and his expertise in the field.
• Guidelines Discussion: Navigate through various international guidelines that shape the PQS framework.
• ICH Q10 Objectives: Align with the International Council for Harmonisation (ICH) objectives for quality.
• Life Cycle Approach: Implement a life cycle approach to better manage the product lifecycle.
• Management Responsibility: Appreciate the managerial responsibilities within the PQS.
• Elements of Pharmaceutical Quality System: Explore the key elements that define a robust PQS.
• Key Message: Summarize the core objectives and applications of PQS.

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Module 3: Key Questions Related to PQR

Gain clarity on the key questions that are often challenging during a PQR. This module is crafted to help you understand the finer nuances, avoid common pitfalls, and ensure your PQR process is error-free and fully compliant.

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Module 4: Conducting Product Quality Review

Understand the expectations from regulatory bodies like the FDA and WHO through this detailed lecture. We will explore:

• Importance of Topic & Know Your Trainer: Learn why PQR is a critical function in quality assurance.
• Expectations about PQR from Different Regulatory Agencies: Tailor your PQR to meet global standards.
• Specific Key Expectations from Regulatory Guides (FDA, WHO): Learn the non-negotiable aspects of PQR according to leading regulatory agencies.
• Elements of Product Quality Review: Identify and understand each element of a successful PQR.
• Practical Approach towards Each Element: Apply practical strategies to each part of the review process.
• Role of Statistical Evaluation in PQR: Master the integration of statistical analysis in your PQR process.
• Live Examples for Statistical Evaluations: Learn through real-world examples, enhancing your understanding of statistical evaluation.
• Broad Differences in Expectations Between EU and FDA: Recognize and adapt to different regulatory perspectives.
• Common Non-Conformances Identified in PQR: Avoid common mistakes by learning from failures in past PQRs.

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Module 5: Continued Process Verification

Differentiate between Continued Process Verification (CPV) and PQR, and understand the unique role CPV plays post-PQR. This module will clarify any confusion and strengthen your knowledge of end-to-end process verification.

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Why Take This Course?

• Regulatory Compliance: Navigate complex regulatory requirements with ease.
• Expert Led: Learn from the experience and expertise of Hitendrakumar Shah.
• Real-World Insights: Gain practical knowledge applicable to your current role.
• Risk Management: Understand how to effectively manage and mitigate risks in quality assurance processes.
• Continuous Improvement: Apply continuous improvement principles to enhance your PQR process after each cycle.

Sign up today and elevate your understanding of Product Quality Reviews! 🌟