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    21 CFR part 11 Compliance - electronic records & electronic signatures

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    Website https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1429&speakerid=48 | Want to Edit it Edit Freely

    Category

    Deadline: May 06, 2019 | Date: May 06, 2019

    Venue/Country: Online, U.S.A

    Updated: 2019-04-25 18:42:46 (GMT+9)

    Call For Papers - CFP

    Overview

    This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained

    Why should you attend this webinar?

    Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483's at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation. This webinar will explain what all this means.

    Areas Covered in the Session:

    Company certification

    Records covered

    Audit trails

    Open /closed system access rules

    Electronic signatures

    Training requirements

    Who can Benefit:

    Engineering personnel

    Regulatory personnel

    IT

    Management

    Speaker Profile:

    Edwin Waldbusser is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing.

    Register: https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1429&speakerid=48

    Contact Info:

    Compliance Key

    Email: supportatcompliancekey.us

    Visit: https://www.compliancekey.us/upcoming-webinars

    Phone: 717-208-8666


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.