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

In this webinar 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.

Angela Bazigos
Instructor:
Angela Bazigos
Duration:
90 Minutes
Product Id:
502246
Access:
6 months

More Trainings by this Expert

Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
Overview:

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:
  • 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


Speaker Profile
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 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.




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