Excellence in Documentation Practices and Regulatory Compliance (FDA & EMA)

Description:

Robust Documentation Practices (RDP) are a cornerstone of success in regulated industries, ensuring that all processes, observations, and unexpected outcomes are meticulously recorded and verified. This 60-minute webinar provides a comprehensive overview of RDP, including its definition, purpose, and critical role in maintaining compliance. It also explores the key principles of RDP (US & EU), best practices for laboratory notebook documentation, and how regulatory authorities enforce these standards, supported by real-world examples from FDA citations.

Why This Webinar is Important:

For professionals involved in manufacturing, quality control, or regulatory affairs, a solid grasp of RDP is non-negotiable. It not only helps avoid costly errors but also ensures readiness for regulatory inspections and audits.

What You Will Learn:

By attending this session, you will gain a clear understanding of:

• The definition, purpose, and value of RDP
• Core principles and guidelines for RDP in the US and EU
• How RDP applies to laboratory notebook documentation
• An introduction to US Pharmacopeia General Chapter <1029> “Effective Documentation Guidelines”
• A snapshot of European Union (EU) RDP requirements
• Real-life examples of RDP enforcement through FDA warning letters

Webinar Agenda:

• Understanding RDP: Definition, Purpose, and Importance
• Key Principles and Best Practices for RDP
• Essential Requirements for Record-Keeping
• Practical Strategies for Effective Documentation:
• Proper use of signatures and initials
• Guidelines for copying and duplicating records
• Maintaining and organizing documents
• Accurate recording of dates and times
• Correcting errors without compromising integrity
• Rounding rules and their significance
• Avoiding backdating and addressing missing data
• Procedures for voiding or canceling records
• Recreating or rewriting records correctly
• Handling deviations and exceptions
• EU Standards for Medicinal Products (Vol. 4: Documentation)
• What’s New in the Latest RDP Updates?
• RDP Enforcement: Insights from FDA Warning Letters