The objective of this course is to provide the student with a good understanding and the best practices for medical device documents, documentation, and record keeping known as Good Documentation Practices through hands-on experiences.

Participants will also acquire knowledge about essential principles related to Good Documentation Practices (GDPs) for data record elements and standards for maintaining quality documentation.

At The End Of The Course You Will Be Able To

• Develop general understanding of what Good Documentation Practices (GDPs) are and why they are relevant for the Medical Devices Industry to ensure compliance to the quality system.

• Learn about key concepts of GMPs for data records elements such as:
  • Data Accuracy
  • Data Integrity
  • Precision
  • Time
  • Legibility
  • Identifiability

• Learn about Good Documentation Standards and the best practices for:
  • Creation
  • Approval
  • Signatures
  • Handwritten Entries
  • Document modification, corrections and review.

• Apply GDP requirements and gain knowledge to solve multiple real case situations through out the class.

Course Content

1. What are Good Documentation Practices.
2. Data Record Elements:
   • Data Accuracy
   • Data Integrity / Validation
   • Time
   • Legibility
   • Identifiable
3. Good Documentation Standards
   • Creation
   • Approval
   • Signatures
   • Handwritten Entries
   • Corrections
   • Review