Regulatory compliance 2019 - If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

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, http://morflearning.com/angelabazigos/, 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 http://www1.diahome.org/~/media/4FA562336EBD46C58C... on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/... 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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144....
Event link: https://www.traininng.com/webinar/if-it-isn't-written-down,-then-it-didn't-happen:-complying-with-fda's-good-documentation-practices-200447live?researchbib-seo
Contact Details:
Joseph Wilcox
Traininng.com LLC
traininngdotcom-AT-gmail.com
Phone:
US: (510) 962-8903
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