OCT 22, 2019 9:00 AM PDT

Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter

Sponsored by: Advanced Instruments
C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • CEO, Touchstone Technologies, Inc.
    Biography
      Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Drugs, Biologics, Medical Devices, Healthcare & Food. Experience combines GxP regulations in Quality Assurance, Regulatory Compliance, Clinical Trial Science, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers, Veracyte and other Medical Device Companies & Stanford Hospital. Consults to startups, investors, pharma, biotech, medical device and food companies. Past Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA and comments on GaMP5 and FDA guidance documents. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx 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 http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Vice President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview .
    • Application Scientist, Advanced Instruments
    • Senior Product Manager - Biotechnology, Advanced Instruments

    Abstract
    DATE:  October 22, 2019
    TIME:   9:00am PDT, 12:00PM EDT
     
    Lack of data integrity is the main reason for most FDA warning letters
     
    In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the Pharma and Biotech Industries this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as Compliance with Data Integrity. The highest risks, when not working in a compliant manner, lie in import bans, product re-calls or even the closing of production plants.
     
    Data integrity in the context of 21 CFR part 11/EU Annex 11 & Computer Systems Validation (CSV) Compliance
     
    The US FDA and European Commission have defined the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of regulated pharmaceutical industries. Regulations and standards such as FDA (21 CFR Part 11), EU (Annex 11), GMP, and ISO (ISO 17025) have recognized both the advantages and limits of electronic data systems and have increasingly established further controls for the use of such systems all the way down to bench top instruments. The goals of reducing errors, simplifying processes, and reinforcing compliance can be enabled by compliance with 21 CFR 11/Annex 11 and Computer Systems Validation. 
     
    OsmoTECH® PRO osmometer supports 21 CFR part 11/EU Annex 11 & CSV Compliance in the measure of Osmolality
     
    Osmolality testing is a valuable parameter for process control and final QC—giving you increased confidence in your products. Designed specifically to fit your Pharma and Biotech compliance needs, the OsmoTECH® PRO Multi-Sample Micro-Osmometer from Advanced Instruments Osmometers support Data Integrity Compliance by delivering the highest level of data management, accuracy and precision, and ease-of-use available on the market today. They provide valuable concentration measurements while delivering unsurpassed data management capabilities, operational efficiency, ease of use, and features that support GMP, 21 CFR Part 11, and EU Annex 11 compliance.
     
    Attendees will Learn the Following During this Presentation:
    • Explain what data integrity is for pharma and biotech industry.
    • Demonstrate how your analytical instruments can be 21 CFR part 11/ EU Annex 11 compliant for data integrity and electronic record management.
    • Recognize the value of osmolality testing as a key process parameter in pharma and biotech industry and how it supports 21 CFR part 11/EU annex 11
     
     
    Webinars will be available for unlimited on-demand viewing after live event.
     
    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.

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