Achieving Compliance Through Effective Documentation Practices (FDA & EMA)

Date: Mar 28, 2025.

Time: 1PM – 2 PM ET

Duration: 60 Min

Description:

Strong Documentation Practices (SDP) are a vital element in regulated industries, ensuring that all processes, observations, and unexpected findings are accurately documented and verified. This 60-minute webinar offers a detailed exploration of SDP, covering its definition, purpose, and importance in maintaining regulatory compliance. It also delves into the fundamental principles of SDP (US & EU), practical advice for laboratory notebook documentation, and how regulatory agencies enforce these standards, illustrated with examples from FDA citations.

Why Attend This Webinar?

If you work in manufacturing, quality assurance, or regulatory compliance, mastering SDP is essential. It helps you avoid errors, stay audit-ready, and ensure adherence to regulatory requirements.

Key Takeaways:

By the end of this session, you will have a solid understanding of:

1. The definition, purpose, and significance of SDP
2. Core principles and guidelines for SDP in the US and EU
3. How SDP applies to laboratory notebook documentation
4. An overview of US Pharmacopeia General Chapter <1029> “Best Practices in Documentation”
5. A brief look at European Union (EU) SDP standards
6. Real-world examples of SDP enforcement through FDA warning letters

Webinar Outline:

1. Introduction to SDP: Definition, Purpose, and Value
2. Fundamental Principles and Guidelines for SDP
3. Critical Requirements for Effective Record-Keeping
4. Best Practices for Documentation Excellence:
5. Proper use of signatures, initials, and their implications
6. Guidelines for copying and reproducing records
7. Organizing and maintaining documents effectively
8. Accurately recording dates and times
9. Correcting errors while maintaining data integrity
10. Understanding rounding rules and their application
11. Avoiding backdating and managing missing data
12. Procedures for voiding or canceling records
13. Recreating or rewriting records appropriately
14. Addressing deviations and exceptions
15. EU Guidelines for Medicinal Products (Vol. 4: Documentation)
16. Updates in the Latest SDP Standards
17. SDP Enforcement: Lessons from FDA Warning Letters

Event Venue

Online