If it Isn’t Written Down, then it Didn’t Happen: Complying with FDA’s Good Documentation Practices
April 14 @ 10:00 am - 1:00 pm CDT$150
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 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.
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
Who Will Benefit:
- Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.
Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.
Netzealous LLC, DBA -Compliance4all
Email: [email protected]