If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

In this webinar, the speaker will explain how to write or record information in a compliant way (includes text, numbers, electronic signatures, etc), In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Documentation provides both:

• Information on when, where, who, why and how to complete tasks, and
• Evidence proving that the tasks have been completed as they should be

If an instruction or record is poorly documented, then the manufacturer or Quality assurance/control of a product, as well as patient safety, can be negatively impacted. The standard of documentation within a company can directly impact the level of success in the quality of products that are safe as well as a success during audit situations. Consequently, GMP /GLP /GCP regulations from PIC/S, FDA, ICH, and EU all include mandatory sections on documentation.

Areas Covered in the Session:-

• Basics of Good Documentation Practices
• Documents vs records
• How to write or record information in a compliant way (includes text, numbers, electronic signatures, etc)
• How to amend documents or records in a compliant way
• Specific contents will include but are not limited to:
  • Document Creation
  • Document Approval
  • Handwritten Entries
  • Copies of Documents
  • Document Maintenance
  • Document Modification
  • Warning Letters for GDocP

Why you should Attend:-

As the FDA and TGA say "If it isn't written down, then it didn't happen". To meet industry standards, it is critical that all documentation follows GDP when it affects:

• GMP /GLP /GCP processes
• Material or product identity, quality, purity, strength, and safety
• The validated state of GMP /GLP /GCP product manufacture, facilities, equipment, computer systems, and testing methods

It is recommended that your company has a policy or procedure outlining the expected GDocP standards, particularly for those requirements that may be unique to your company - for example, using a specific pen color or when and how to use scanned documents/records as original data.

Who Will Benefit:-

Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff