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Overview of the Consolidated ICH Q1 Replacing Q1A-F and Q5C

SLIDE 1 — OPENING HOOK (≈45 sec)

SLIDE 2 — CONCEPT SIMPLIFIED (≈60 sec)

10 Key Concepts from the ICH Q1 Draft Guideline

SLIDE 3 — CASE STUDY WITH CHARACTERS AND DIALOGUE (≈90 sec)

SLIDE 4 — PRACTICAL APPLICATION (≈60 sec)

10-Point Audit / Readiness Checklist

Assessment — 5 Multiple-Choice Questions

MCQ 1

MCQ 2

MCQ 3

MCQ 4

MCQ 5

Survey and Course Feedback

Part B — Reflection

Who Is the Mini-Course For?

Welcome to "Understanding the Draft Consolidated ICH Q1 Stability Guideline," a comprehensive mini-course designed to help pharmaceutical professionals navigate the latest regulatory updates in stability testing. The International Council for Harmonisation (ICH) has proposed a major consolidation, replacing legacy stability guidelines (Q1A(R2) through Q1F, and Q5C) with a single, unified document.

Welcome to "Understanding the Draft Consolidated ICH Q1 Stability Guideline," a comprehensive mini-course designed to help pharmaceutical professionals navigate the latest regulatory updates in stability testing. The International Council for Harmonisation (ICH) has proposed a major consolidation, replacing legacy stability guidelines (Q1A(R2) through Q1F, and Q5C) with a single, unified document. This course breaks down the primary purpose, scope, and rationale behind this monumental shift, addressing historical fragmentation and the need for clear guidance on newer modalities like biologics, vaccines, and ATMPs. Throughout this course, you will explore the structural shape of the new draft guideline and its place within the broader ICH Q8–Q12 quality framework. We will differentiate between concepts that are genuinely changing—such as lifecycle thinking and formalized lean/model-based designs—and those that remain intact. Through engaging case studies and practical applications, you will learn how to handle the current Step 2b draft status, avoiding the compliance risks of premature adoption while proactively preparing your QA, QC, Manufacturing, and Regulatory Affairs teams. Finally, you will gain access to a 10-Point Audit and Readiness Checklist to evaluate your site's current compliance baseline, identify gaps in SOPs, and organize a proactive readiness strategy. Join us to ensure your stability programs remain compliant, efficient, and ready for the future of global regulatory submissions.

Overview of the consolidated ICH Q1 replacing Q1A-F and Q5C

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            <p>The pharmaceutical and biopharmaceutical industries are currently navigating a significant regulatory transition with the introduction of the draft consolidated ICH Q1 Stability Guideline. Historically, stability testing principles were fragmented across multiple documents, including the legacy Q1A through Q1F series and Q5C, which often led to inconsistent interpretations and challenges when applying standards to newer therapeutic modalities. This comprehensive program examines the newly proposed framework, which aims to harmonize stability expectations across an expanded scope of product types, ranging from traditional synthetic molecules to complex biologics, vaccines, and Advanced Therapy Medicinal Products (ATMPs). By consolidating these requirements into a single, cohesive document, the International Council for Harmonisation (ICH) seeks to streamline global regulatory submissions, integrate lifecycle thinking, and support formalized, model-based study designs.</p>

<p>Throughout this curriculum, professionals across Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, and Validation will bridge the gap between emerging regulatory theory and practical, site-level application. Participants will analyze the foundational concepts of the draft guideline and evaluate its current Step 2b regulatory status, gaining a clear understanding of the compliance risks associated with prematurely adopting unfinalized guidance. Furthermore, the course provides actionable strategies for organizational readiness. Utilizing a structured 10-point audit checklist and targeted case studies, cross-functional teams will learn how to conduct effective gap and impact assessments. This proactive approach ensures that facilities can systematically evaluate their current standard operating procedures and analytical capabilities, preparing their stability programs for future enforcement without disrupting currently validated operations.</p>
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