If it is not written down, it did not happen – Complying with FDA’s Good Documentation Practices

GDP is commonly abbreviation for Good Documentation Practice. It has been recommended to be abbreviated as GDocP to distinguish from “good distribution practice” also abbreviated GDP. Now, GDP is a term in the regulated industry to characterize standards by which documents are created and maintained.

In both pharmaceutical and medical device environment documentation plays a crucial role in meeting the essential requirements to ensure product quality and 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 for any reason an instruction or record is not documented properly, then the QA/QC team or the manufacturer of a product as well as patient safety can be affected, to the extent of bringing a negative impact on the organization. The guidelines of documentation within your organization can directly impact the success of an Audit situation. 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 a best practice, that all companies have a policy or procedure outlining the expected GDocP standards, especially for those specifics that may be exclusive to your organization – for example, using a distinct 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 Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • IT and Software Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Marketing Departments
  • Documentation Departments
  • Laboratory Professionals
  • Clinical Research Associates
  • GXP Professionals
  • Everyone that creates records in a regulated industry

FDB1600

Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

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.

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.

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