Mastering Documentation Practices&Compliance Regulatory Standards( FDA&EMA)

Date: June 13, 2025.

Time: 1PM – 2 PM ET

Duration: 60 Min

Description:

Effective Documentation Practices (EDP) are a critical component that must be diligently adhered to by professionals in regulated environments to ensure successful project execution. This includes accurately recording and verifying observations, including any unexpected outcomes. This 60-minute webinar delves into the fundamentals of EDP, its definition, purpose, and significance. It further explores the general guidelines and principles of EDP (US & EU), practical tips for maintaining laboratory notebooks, and concludes with a discussion on how regulatory agencies enforce EDP across various regions, including examples of FDA citations.

Why You Should Attend:

If you are engaged in product manufacturing or quality assurance, understanding EDP regulations is essential. It helps prevent errors, ensures compliance, and reduces the risk of non-conformance during regulatory audits.

Key Topics Covered:

By the end of this webinar, you will have a foundational to intermediate understanding of:

1. The definition, purpose, and importance of EDP
2. General principles and rules of EDP
3. Application of EDP to laboratory notebook documentation
4. An overview of US Pharmacopeia General Chapter <1029> “Good Documentation Guidelines”
5. A brief introduction to European Union (EU) EDP standards
6. Enforcement of EDP, including real-world examples from FDA warning letters

Webinar Outline:

1. Definition, Purpose, and Significance of EDP
2. General Principles and Guidelines of EDP
3. Record-Keeping Requirements

Practical Tips for Effective Documentation:

1. Signatures, initials, and their implications
2. Copying and duplicating records
3. Document retention and maintenance
4. Timely recording of dates and times
5. Correcting errors appropriately
6. Rounding rules and their application
7. Avoiding backdating and handling missing data
8. Voiding or canceling records
9. Recreating or rewriting records
10. Managing deviations
11. EU Guidelines on Medicinal Products (Vol. 4: Documentation)
12. Updates in the Latest Version of EDP Standards
13. Enforcement of EDP: Case Studies from FDA Warning Letters