Good Documentation Practices (GDocP)

This Good Documentation Practices (GDocP) webinar is designed by an experienced industry professional to help personnel working with controlled documents understand GDocP requirements, their role in compliance, and the consequences of non-compliance. Unlike other courses, this session focuses on practical solutions making it highly applicable to daily operations.

WHY YOU SHOULD ATTEND:

Good Documentation Practices (GDocP) are essential for ensuring compliance in the regulated industries such as the pharmaceutical industry. Regulatory authorities such as the FDA, EMA, and WHO require organizations to maintain clear, accurate, and traceable documentation to prevent data integrity issues and regulatory violations. Poor documentation can result in regulatory actions, product recalls, and reputational damage.

This webinar provides a comprehensive understanding of GDocP principles, including documentation requirements, proper record-keeping, and compliance strategies. Participants will learn how to identify and correct common documentation errors, understand the lifecycle of controlled documents, and implement best practices to maintain regulatory compliance. The session will also address common challenges in document management and offer practical solutions to ensure consistency, accuracy, and reliability in documentation.

Whether you are a quality professional, regulatory affairs specialist, or production team member, this training will equip you with the necessary skills to implement and maintain best documentation practices within your organization. 

LEARNING OBJECTIVES:

• Understand the importance of GDocP. 
• Learn key guidelines and regulatory expectations for maintaining accurate documentation. 
• Identify common documentation errors and best practices for correction. 
• Understand best practices for addressing torn, damaged, or missing records
• Recognize data tampering and its impact on regulatory compliance. 
• Understand the significance of signatures and their proper use. 
• Gain insights into the document lifecycle, from creation to archiving.
• Explore challenges in document management and how to overcome them. 
• Analyze real-world observations and regulatory expectations for compliance.

AREAS COVERED:

* You will also receive a Whitepaper 'Good Documentation Practices' by Tim Sandle

• Introduction
• Documentation:
  • Definition of Documentation
  • Why documentation is essential
  • Documentation main rules
• Good documentation practices (GDocP):
  • What are Good documentation practices (GDocP)
  • Common guidelines for GDocP
• How are mistakes corrected?
  • Error correction steps
  • Explanations codes
  • Common guidelines for error correction
• Torn/damaged Documents:
  • What to do in case torn/ damaged documents
• Data tampering:
  • What is data tampering?
• Signatures:
  • What does my signature mean?
  • Common guidelines for signatures
• Documents:
  • Types of documents
  • Document Lifecycle
  • Generation and control of documentation.
• Common Challenges in Document Management
• Common Observations
• Real Examples of Observations
• Q&A

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Production Departments
• Research and Development Departments
• Compliance Departments
• Engineering Departments
• Validation Personnel 
• Auditors and Inspectors 
• Regulatory Affairs Departments
• Everyone who need a fundamental understanding of the GDocP requirements for pharmaceutical products

Course Director: Esraa Abu-Karaki

Esraa Abu-Karaki is a seasoned expert with over 20 years of experience in quality management, compliance, and continuous improvement within the pharmaceutical industry. She has held leadership roles at leading pharmaceutical companies, including Hikma Pharmaceuticals. Esraa specializes in auditing, training, quality system development, and digital transformation. She has established and led multiple departments, including the Corporate Quality Department, driving quality excellence. She has successfully prepared pharmaceutical facilities for inspections, leading and playing a crucial role in securing certification and recertification of multiple sites by global regulatory authorities, such as the EU and US FDA. Her work ensures compliance with GMP and GxP standards, strengthens regulatory compliance, and improves and unifies quality systems through the development and implementation of comprehensive quality policies. As an independent consultant and trainer, Esraa provides expert guidance on pharmaceutical quality systems, data integrity, and regulatory compliance. She has trained professionals across various regions, making complex regulations practical and easy to implement through structured training and hands-on experience.