If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
10:00 AM PDT | 01:00 PM EDT
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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 manufacture 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 quality of products that are safe as well as success during audit situations. Consequently, GMP /GLP /GCP regulations from PIC/S, FDA, ICH and EU all include mandatory sections on documentation.
Why should you 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.
Areas Covered in the Session:
Who Will Benefit:
- 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
- Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff