Good Documentation Practice (GDocP) Training Course

• 3-Hour Course
• Webinar or Face to Face (F2F) Learning
• Expert Trainer With Actual GDocP Regulatory Inspection Experience

This 3-hour course aims to provide the knowledge and skills required to complete GxP documentation to the required standard for regulatory authority inspections.

Learning Outcomes

In this course you’ll learn about essential concepts and practices to ensure that documentation is produced to the required standard for regulatory authority inspection. The ultimate learning goal is to equip students with the knowledge and skills to ensure documentation provides integrity to help ensure patient safety.

Understand The Importance Of Documentation In The Life Science Industry:

• Familiarity with regulatory requirements and guidelines governing documentation practices, such as FDA regulations, ISO standards, GMP (Good Manufacturing Practice), etc.
• Gain knowledge of different types of documents commonly used in regulated environments, including SOPs (Standard Operating Procedures), batch records, validation protocols, reports, etc.
• Learn of the impact poor documentation practices have on product quality, regulatory compliance, and patient safety.

Gain Document Generation, Completion And Management Skills:

• Gain the ability and skills to create clear, concise, accurate, and compliant documentation following GDocP completion principles.
• Learn the best practices for document control, including version control, change control, and document lifecycle management.
• Understand the importance of data integrity and traceability in documentation.
• Gain competence in handling documentation deviations, corrections, and investigations in accordance with regulatory requirements.
• Understand how to apply GDocP principles in everyday work activities to ensure compliance and contribute to a culture of quality and continuous improvement.

Target Audience

This course will be of great value to anyone currently working in the Life Sciences Industry, or any other highly regulated industry that is subject to regulatory inspections.

Examination

The course is concluded with an optional examination.