PPT-21 CFR PART 11

Author : trish-goza | Published Date : 2018-01-10

AGENDA 21 CFR Part 11 Sections in 21 CFR Part 11 Terminology About Part 11 Importance of Part 11 Scope of Part 11 Applications Advantages Validation Predicate rule

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21 CFR PART 11: Transcript


AGENDA 21 CFR Part 11 Sections in 21 CFR Part 11 Terminology About Part 11 Importance of Part 11 Scope of Part 11 Applications Advantages Validation Predicate rule requirements Security Procedures. EP EH MEANINGFUL USE 42 CFR 495.6(j)(m) Stage 2 Objective MEANINGFUL USE 42 CFR 495.6(j)(m) Stage 2 Measure 2014 Edition EHR CERTIFICATION CRITERIA 45 CFR 170.314 STANDARDS CORE EP EH Record s A Post-Award Primer. Division of Grants Compliance and Oversight. Office of Policy for Extramural Research Administration, OER. National Institutes of Health, DHHS . NIH Regional Seminar – Baltimore, MD – June 2014. Pam Truitt, Grants Specialist. September 10, 2015. Why Environmental Review?. Avoid . or mitigate impacts that may harm . residents . Avoid . litigation that could . halt a project . on environmental grounds. Noam Brown. Carnegie Mellon University. Computer Science . Department. Review: Imperfect-Information Game Tree. Information . set. 0.3. 0.5. 0.2. 0.5. 0.5. Negotiations, security, poker. P1. P1. P1. C. Nonprofits. OMB Super Circular. Released 12/26/2013. 2 years of study, 2 drafts. Goal: Better Management of Federal Funds. 2 CFR Part 200. From 8 to 1. OMB Super Circular combines 8 grant related circulars into 1 document, supersedes current:. Geary Keeton, CFE. Chief of Enforcement . (Program Manager, Enforcement). Disclaimer. 2. The . statements or opinions expressed in all ONRR presentations and panel discussions at the 2017 PASO-Tulsa Federal/Indian Royalty Compliance Workshop do not necessarily represent the views of ONRR or the Department of the . Charles Yan, PhD. Senior Director, Clinical Data Management. Jiangsu . Hengrui. Pharmaceutical Co. LTD. Topics. What is Part 11. Background. Scope and Component . R. equirements. FDA 21CFR11 . Inspection . Division of Grants Compliance and Oversight. Office of Policy for Extramural Research Administration, OER. National Institutes of Health, DHHS . NIH Regional Seminar – New Orleans– May 2017. Diane Dean. 2. How do they effect . you everyday?. . NAADAC 2014 -. All photos © Gr8fulTed Productions. Objectives. We want you to come out of this session with enough of a general understanding to keep you (mostly) out of trouble regarding confidentiality rules and regulation.. 38 CFR Presented by Field Office Topics Covered How to Access the CFR 38 CFR Part 3 38 CFR Part 4 38 CFR Additional Useful Parts Good Sections to Tab Exercises Ways to Access the CFR CFR Book eCFR (www.ecfr.gov) U.S. Food & Drug 10903 New Hampshire Avenue 3 Silver Spring, MD 20993 www.fda.gov May 13, 2019 Tiffini Wittwer Consulting Director of Regulatory Affairs 221 Pine St #200 San Francisco, California 9 Page 2- Dr. GerkensmneierPlease be advised that FDA's issuance of a substantial equivalence determination does notmean that FDA has made a determination that your device complies with other requiremen U.S. Food & Drug 10903 New Hampshire Avenue Doc ID# 04017.04.1 7 Silver Spring, MD 20993 www.fda.gov VIDA Diagnostics Inc. August 7, 2020 ℅ Alex Morris Director, Quality and Regulatory 2500 Crosspa Classification Name: Colonoscope/Sigmoidoscope AccessoryEquivalence: 510O(K) K051004, ProtectiScope CS, Stryker GI(disposable sheath only)510O(K) K032688, Colonosight Model 51lOB,Sightline Technologie

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