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

  • ID: 4997647
  • Webinar
  • April 2020
  • Region: Global
  • 90 Minutes
  • NetZealous LLC
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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.
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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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  • Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff
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