Introduction - AVITSENA

Advanced Data Integrity for Pharmaceutical Manufacturing Introduction

Advanced Data Integrity for Pharmaceutical Manufacturing

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Introduction

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Learning Objectives

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Who Should Take This Course

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Module 1 ALCOA+ Principles

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Module 1 The Plus in the ALOCA+

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Module 1 Importance of Data Integrity in Pharmaceuticals

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Module 1 Regulatory Requirements for Data Integrity

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Module 1 Common Data Integrity Challenges

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Module 1 Ensuring Data Integrity – Best Practices Part 1

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Module 1 Ensuring Data Integrity – Best Practices Part 2

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Module 1 Summary and Key Takeaways

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Reflection Prompt for Journaling Exercise

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Module 2: Common Data Integrity Issues Highlighted by Regulators

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Module 2 : Key Regulatory Bodies and Standards

Module 2: Key Regulatory Bodies and Standards

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Module 2: Regulatory Frameworks and Compliance for Data Integrity

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Module 2: Summary & Key Takeaways

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Module 3: Data Integrity Risk Management in Manufacturing

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Module 3: Identifying Data Integrity Risks

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Module 3: Qualitative Risk Assessment Techniques

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Module 3: Quantitative RA Techniques

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Module 3: Risk Mitigation Strategies

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Module 3: Risk-Based Audit Plans

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Module 3: Case Study Risk Management in Action

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Module 3: Summary & Key Takeaways

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Advanced Data Integrity for Pharmaceutical Manufacturing Introduction

Advanced Data Integrity for Pharmaceutical Manufacturing