FDA and EMA Expectations for Good Documentation Practices (GDP) in GMP and GCP Environments

Good Documentation Practices (GDP) are a critical requirement in both Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) environments, ensuring the accuracy, integrity, and reliability of records that support regulatory compliance.

This webinar will explore the FDA and EMA expectations for GDP, covering key regulatory frameworks, including FDA 21 CFR Parts 211, 820, 312, and 812, as well as EMA EudraLex Volume 4 and ICH E6 (R2). Participants will learn how to implement ALCOA+ principles, manage paper and electronic records, handle documentation errors, and ensure compliance in audits and inspections. Through practical examples and case studies, attendees will gain valuable insights into maintaining documentation integrity, reducing regulatory risks, and aligning with global standards for GMP and GCP.

Why you should Attend:
Accurate and compliant documentation is the backbone of regulatory success in GMP and GCP environments, and failure to meet FDA and EMA expectations can lead to serious compliance risks.

This webinar is essential for professionals in manufacturing, clinical research, quality assurance, and regulatory affairs who want to strengthen their understanding of Good Documentation Practices (GDP). Participants will learn how to apply ALCOA+ principles, manage paper and electronic records, and prevent common documentation pitfalls. Through expert insights and real-world case studies, this session will provide practical strategies to improve documentation integrity, streamline compliance efforts, and confidently prepare for regulatory inspections.

Areas Covered in the Session:

• Introduction
• Welcome and Objectives
• Importance of Good Documentation Practices (GDP)
• Overview of Regulatory Authorities: FDA vs. EMA
• Key Differences in GMP and GCP Documentation Requirements
• Regulatory Framework and Expectations
• GMP Requirements for GDP
• FDA 21 CFR Part 211 & 21 CFR Part 820
• EMA EudraLex Volume 4 (Annex 11 & Annex 15)
• GCP Requirements for GDP
• FDA 21 CFR Part 312 & Part 812
• EMA ICH E6 (R2) - Good Clinical Practice
• Documentation Expectations: Accuracy, Legibility, Traceability, and Compliance
• Common Documentation Deficiencies Identified in Inspections
• Principles of Good Documentation Practices
• ALCOA+ Principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
• Handling Paper vs. Electronic Documentation
• Requirements for Raw Data, Records, and Reports
• Change Control and Version Control in Documentation
• Documentation Integrity: Audit Trails, Data Security, and Retention
• Documentation Best Practices in GMP and GCP
• Writing Clear, Concise, and Compliant SOPs, Protocols, and Reports
• Review and Approval Processes: Roles and Responsibilities
• Handling Corrections and Deviations in Documentation
• Ensuring Consistency Between GMP Batch Records and GCP Study Records
• Training Staff on GDP Compliance
• Case Studies & Common Pitfalls
• Real-World Examples of GDP Non-Compliance and Its Consequences
• Best Practices for Avoiding Regulatory Findings

• Quality Assurance (QA) Manager
• Quality Control (QC) Specialist
• Regulatory Affairs Specialist
• Compliance Officer
• Clinical Research Associate (CRA)
• Clinical Research Coordinator (CRC)
• Clinical Quality Manager
• Documentation Specialist
• Manufacturing Supervisor
• GMP Auditor
• GCP Auditor
• Validation Specialist
• Process Engineer
• Laboratory Manager
• Pharmacovigilance Specialist
• Medical Writer
• R&D Scientist
• Training Manager
• Supplier Quality Manager
• Operations Manager