Code of Conduct: Our Principles of Ethics & Integrity
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Product Retrieval Procedures
PRODUCT RETRIEVAL PROCEDURES X-1 INDEX PAGE Overview 3 Analysis of FDA Recall Guidelines 4 A Product Retrieval Blueprint for Action 11 Food & Drug Regulations Title 21, Chapter 1 32 Subchapter A, Parts 7, 7.1 through 7.49 Method for Conducting Retrieval Effectiveness Checks 46 Published by Food and Drug Administration Example -- Corporate Retrieval Program 56 X-2 FOOD AND DRUG RECALL GUIDELINES OVERVIEW The regulations set forth in the Federal Register on June 16, 1978, established the following facts: 1. If an emergency of retrieval arises, it is the responsibility of a manufacturer or distributor to initiate voluntarily and carry out a retrieval of its product that is found to be in violation of the Food and Drug Act. 2. The retrieval must be initiated when the manufacturer discovers or is informed of the infraction. 3. The burden in carrying out a retrieval is totally that of a manufacturer or distributor. 4. Although a retrieval will be conducted by a manufacturer or distributor, it must be carried out to satisfaction of the FDA. To be able to conduct a product retrieval to the satisfaction of the FDA, the following preparation and conditions are essential: 1. An established contingency plan. 2. Assigned responsibility and authority to specific management personnel to carry out the contingency plan. 3. A thorough understanding of the regulation guidelines on retrieval. 4. Recognition of the urgency that FDA places on effectiveness, promptness and thoroughness. 5. Accurate documentation of ingredient and materials used. 6. Accurate documentation of distribution of products. 7. Accurate coding. The proof of effectiveness can only be learned through Trial Runs. -
Collaboration Dignity Quality Sustainability Teamwork
20 REPORT TO THE 16COMMUNITY QUALITY SUSTAINABILITY COLLABORATION TEAMWORK DIGNITY VOLUNTEERISM OUR MISSION: Through the effective reuse of donated items, Bridging improves lives by providing quality furniture and household goods to those transitioning out of homelessness and poverty. A MESSAGE FROM LEADERSHIP FINANCIALS Dear Friends, Wow, what a year! 2016 certainly was REVENUE 2016 2015 a tremendous year for Bridging in many In-Kind $6,416,138 $5,926,394 ways. Through amazing partnerships Foundations, Grants, $2,159,043 $3,859,066 with our agencies, volunteers and donors, Contributions* we accomplished much: • Successfully moved into our NEW Service Fees $1,142,927 $1,036,224 Roseville warehouse. Other Revenue $393,823 $224,892 • Completed a $4 million capital Total Revenue $10,111,931 $11,046,576 campaign. * Total includes Capital Campaign: launched in 2015, • Reached record numbers in attendance and funds raised completed in 2016. for all three of our special events. • Developed a three-year strategic plan; simply called, EXPENSES 2016 2015 “Serve More, Better.” Program Services $8,284,311 $8,051,167 • Provided a complete, basic home set-up for 4,474 clients Fundraising $348,541 $314,166 in our community. Management and General $221,112 $209,277 These clients represent 13,527 individual lives (more than half are children) that have been touched by YOU. Each life has Total Expenses $8,853,964 $8,574,610 an important story. I hope that you enjoy reading this year’s Report to the Community and learning more about the impact BALANCE SHEET 2016 2015 of your partnership; most importantly, I hope you read about a few of the lives you have touched. -
PEOPLE SERVING PEOPLE 2016 Annual Report 2016 Was a Year of Significant Growth for People Serving People
“Spending time with the kids here re-charges me. Their positivity, humor, and resiliency brings light to my week, and fills me with a sense of hope.” – Cora, Volunteer Tutor PEOPLE SERVING PEOPLE 2016 Annual Report 2016 was a year of significant growth for People Serving People. People Serving RYAN STRACK Recognizing the trauma our guests have experienced and Minneapolis Public Schools the lasting impact it has on physical and emotional health, we People, Inc. undertook an initiative to become trauma-informed throughout ANDREA TURNER our operations and service delivery. An organizational self- DREW FESLER, CHAIR General Mills assessment, professional development trainings, and staff-led ECMC Group work groups have helped us identify and implement changes to make People Serving People a more supportive, healing space JOSEPHINE PUFPAFF, People Serving People for both guests and staff. VICE CHAIR Corporation for Charities, Inc. This year we also designed and completed construction on a Supportive Housing new external initiative, the Center of Excellence, opening in GUY BECKER, CHAIR 2017. This initiative expands our physical presence to two sites and marks a shift in our service population to include STEFANI TYGAR BARNES Kristopher James Company children and families at-risk of experiencing homelessness. In Wells Fargo Insurance, Inc. CHRISTOPHER CLARK, addition to direct care services, the Center will feature research, development, and training to improve the field of family JESSE BERGLANDK VICE CHAIR resilience and trauma-informed education and service. Northwestern Mutual Xcel Energy Our shelter’s Early Childhood Development Program received LATOYA BURRELL ELIZABETH HINZ national accreditation in September 2016 by the National North Central University Formerly at Minneapolis Public Early Childhood Program Accreditation. -
Gossip, Exclusion, Competition, and Spite: a Look Below the Glass Ceiling at Female-To-Female Communication Habits in the Workplace
University of Tennessee, Knoxville TRACE: Tennessee Research and Creative Exchange Masters Theses Graduate School 5-2013 Gossip, Exclusion, Competition, and Spite: A Look Below the Glass Ceiling at Female-to-Female Communication Habits in the Workplace Katelyn Elizabeth Brownlee [email protected] Follow this and additional works at: https://trace.tennessee.edu/utk_gradthes Part of the Organizational Communication Commons Recommended Citation Brownlee, Katelyn Elizabeth, "Gossip, Exclusion, Competition, and Spite: A Look Below the Glass Ceiling at Female-to-Female Communication Habits in the Workplace. " Master's Thesis, University of Tennessee, 2013. https://trace.tennessee.edu/utk_gradthes/1597 This Thesis is brought to you for free and open access by the Graduate School at TRACE: Tennessee Research and Creative Exchange. It has been accepted for inclusion in Masters Theses by an authorized administrator of TRACE: Tennessee Research and Creative Exchange. For more information, please contact [email protected]. To the Graduate Council: I am submitting herewith a thesis written by Katelyn Elizabeth Brownlee entitled "Gossip, Exclusion, Competition, and Spite: A Look Below the Glass Ceiling at Female-to-Female Communication Habits in the Workplace." I have examined the final electronic copy of this thesis for form and content and recommend that it be accepted in partial fulfillment of the requirements for the degree of Master of Science, with a major in Communication and Information. Michelle Violanti, Major Professor We have read this thesis -
A Thesis Entitled Quality of Life of People Who Stutter by Emily
A Thesis entitled Quality of Life of People who Stutter by Emily Figliomeni Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Arts Degree in Speech Language Pathology _________________________________________ Dr. Rodney Gabel, Ph.D., CCC-SLP, BCS-F, Committee Chair _________________________________________ Dr. Stephanie Hughes, Ph.D., CCC-SLP, Committee Member _________________________________________ Mrs. Jennifer Glassman, M.A. CCC-SLP, Committee Member _________________________________________ Dr. Patricia R. Komuniecki, Ph.D., Dean College of Graduate Studies The University of Toledo May 2015 Copyright 2015, Emily Figliomeni This document is copyrighted material. Under copyright law, no parts of this document may be reproduced without the expressed permission of the author. An Abstract of Quality of Life of People who Stutter by Emily Figliomeni Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Arts Degree in Speech Language Pathology The University of Toledo May 2015 Stuttering is a communication disorder that can impact a person’s life. The purpose of this study was to qualitatively explore the impact of stuttering on quality of life (QOL), and the differences between the beliefs of people who stutter (PWS) and the speech-language pathologist (SLP) regarding this issue. Individual experiences were obtained through the process of open-ended interviews with six PWS, and six SLPs who work with PWS. Major recurring themes included: 1) restriction, 2) identity, 3) positivity, 4) control, and 5) therapy impact. Similar beliefs were shared among individuals in both groups of participants, and were reflected in additional minor themes including therapy impact on QOL, physical impact, empowerment, acceptance, authenticity, and restriction regarding occupation and personal relationships. -
Sound Ethics in Health Care in Depth: Speak Up! Listen Up! May 14, 2018
Sound Ethics in Health Care In Depth: Speak Up! Listen Up! May 14, 2018 Dr. John Billig: Hello, and thank you for joining today's IntegratedEthics Improvement Forum Call. I'm John Billig, Chief of IntegratedEthics. As you probably know, today marks the beginning of National Compliance and Ethics Week in VA. This year's theme is Speak up! Listen up! And today's call will celebrate that theme. It promises to be an interesting and enlightening discussion. And now to kick things off, it's my great pleasure today to introduce our first speaker, Dr. Gerard Cox. Dr. Cox is Acting Deputy Under Secretary for Health for Organizational Excellence while continuing to serve as Assistant Deputy Under Secretary for Health for Integrity. Prior to his current role, he served as Assistant Deputy Under Secretary for Health for Policy and Services, Interim Medical Inspector, and Assistant Deputy Under Secretary for Health for Integrity. Before joining VA in 2014, Dr. Cox spent more than 30 years in military medicine. As a U.S. Navy medical officer, he served in a series of hospital leadership roles with increasingly complex management responsibilities, including service chief, service line leader, chief operating officer, and chief executive officer. He also held executive positions with the Navy Surgeon General, the commandant of the Marine Corps, the commander of U.S. Navy forces in the Middle East, and the Naval Inspector General. In addition, Dr. Cox served as a White House physician for Presidents William J. Clinton and George W. Bush. Dr. Cox, thank you for joining us today. -
The Office” Sample Script
“THE OFFICE” SAMPLE SCRIPT “The Masseuse” by John Chang [email protected] FADE IN: INT. OFFICE – MORNING MICHAEL enters and stops by PAM’S desk. MICHAEL Morning, Pam. Did you catch the ‘L Word’ last night? PAM No. I missed it. MICHAEL It was a great episode. Tim found out that Jenny was cheating on him with Marina, and Dana and Lara broke up. But the whole thing was totally unbelievable. PAM Why? MICHAEL Because. There’s no way that lesbians are that hot in real life. I know that we all have our fantasies about a pair of hot lesbian chicks making out with each other, but that’s just not how it is in the real world. PAM Um, o-kay. MICHAEL I mean, seriously, Pam. There’s no way in a million years that a smoking hot lesbian babe would come up to you and ask you out on a date. It just wouldn’t happen. I mean, I’m sure you must be very attractive to plenty of lesbians out there, but let’s face facts: they don’t look like Jennifer Beals, they look like Rosie O’Donnell. 2 MICHAEL (cont’d) That’s why the ‘L Word’ is just a TV show, and this is real life. And Pam, for what it’s worth, if you were a lesbian, you’d be one of the hotter ones. PAM Um, thanks. As Michael heads for his office, Pam turns to the camera. Her expression asks, “Did he just say that?” END TEASER INT. OFFICE - DAY It’s business as usual, when the entrance of an extremely attractive young woman (MARCI) interrupts the office’s normal placid calm. -
Preventing Falls in Hospitals: a Toolkit for Improving Quality of Care
Preventing Falls in Hospitals A Toolkit for Improving Quality of Care The information in this toolkit is intended to assist service providers and hospitals in developing falls prevention protocols. This toolkit is intended as a reference and not as a substitute for professional judgment. The opinions expressed in this document are those of the authors and do not necessarily reflect the views of AHRQ. No statement in this toolkit should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services. In addition, AHRQ or U.S. Department of Health and Human Services endorsement of any derivative product may not be stated or implied. Preventing Falls in Hospitals A Toolkit for Improving Quality of Care Prepared for: Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Prepared by: RAND Corporation Boston University School of Public Health ECRI Institute Contract No. HHSA290201000017I TO #1 AHRQ Publication No. 13-0015-EF January 2013 Authors RAND Corporation David A. Ganz, M.D., Ph.D., VA Greater Los Angeles Healthcare System, University of California at Los Angeles, and RAND Corporation Christina Huang, M.P.H., RAND Corporation Debra Saliba, M.D., M.P.H., VA Greater Los Angeles Healthcare System, UCLA/JH Borun Center for Gerontological Research, and RAND Corporation Victoria Shier, M.P.A., RAND Corporation Boston University School of Public Health Dan Berlowitz, M.D., M.P.H., Bedford VA Hospital and Boston University School of Public Health Carol VanDeusen Lukas, Ed.D., VA Boston Healthcare System and Boston University School of Public Health ECRI Institute Kathryn Pelczarski, B.S. -
Department of Health and Human Services
Vol. 78 Wednesday, No. 39 February 27, 2013 Part II Department of Health and Human Services 45 CFR Parts 144, 147, 150, et al. Patient Protection and Affordable Care Act; Health Insurance Market Rules; Rate Review; Final Rule VerDate Mar<15>2010 15:19 Feb 26, 2013 Jkt 229001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\27FER2.SGM 27FER2 erowe on DSK2VPTVN1PROD with RULES_2 13406 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations DEPARTMENT OF HEALTH AND A. Part 144—Requirements Relating to Federal Register proposed rule entitled HUMAN SERVICES Health Insurance Coverage ‘‘Patient Protection and Affordable Care 1. Subpart A—General Provisions Act; Health Insurance Market Rules; 45 CFR Parts 144, 147, 150, 154 and B. Part 147—Health Insurance Reform Rate Review’’ (77 FR 70584). These 156 Requirements for the Group and Individual Health Insurance Markets standards apply to health insurance [CMS–9972–F] 1. Fair Health Insurance Premiums issuers offering non-grandfathered 2. State Reporting health insurance coverage both inside RIN 0938–AR40 3. Guaranteed Availability of Coverage and outside of the new competitive 4. Guaranteed Renewability of Coverage marketplaces called Affordable Patient Protection and Affordable Care C. Part 150—CMS Enforcement in Group Insurance Exchanges, or ‘‘Exchanges.’’ Act; Health Insurance Market Rules; and Individual Insurance Markets This final rule: (1) Provides that Rate Review D. Part 154—Health Insurance Issuer Rate health insurance issuers may vary the Increases: Disclosure and Review AGENCY: Department of Health and premium rate for health insurance Requirements coverage in the individual and small Human Services. -
Casino Skills for Working with Others Participant Manual: Edition 1.0
Casino Skills for Working with Others Participant Manual: Edition 1.0 Casino Skills for Working with Others: Essential Skills for the Gaming Industry Produced By: The Canadian Gaming Centre of Excellence (An operating division of The Manitoba Lotteries Corporation) 983 St. James Street Winnipeg, Manitoba R3H 0X2 (204) 957-2504 ext. 8498 e-mail: [email protected] Contact: Judith Hayes, Director Dayna Hinkel, Business Development Officer © 2010 Canadian Gaming Centre of Excellence (CGCE). All rights reserved. All material in this manual is the property of the CGCE. This publication, or any part thereof, may be used free of charge and permission is granted to reproduce for personal or educational use only. Commercial copying or selling is prohibited. In all cases this copyright notice must remain intact. Special Thanks: The Canadian Gaming Centre of Excellence would like to acknowledge the assistance of the following organizations and individuals in producing this manual: Aseneskak Casino Judy Goodridge, Chief Operating Officer Eleanor Gabriel, Human Resources Delores Lavallee, Manager, Human Resources Atlantic Lottery Corporation Alison Stultz, Director Organizational Development British Columbia Lottery Corporation: Mitch Romanchook, Manager Technical Services Talent Management – Human Resources Canadian Gaming Association Paul Burns, Vice President of Public Affairs Casino Rama Debra Pratt, Chief People Officer Century Casino & Hotel Nicole Jofre, Human Resources Great Canadian Gaming Corporation Sally Hart, Executive Director Human Resources -
Overview of Key Readmission Measures and Methods
HCUP Methods Series Contact Information: Healthcare Cost and Utilization Project (HCUP) Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 http://www.hcup-us.ahrq.gov For Technical Assistance with HCUP Products: Email: [email protected] or Phone: 1-866-290-HCUP Recommended Citation: Barrett M, Raetzman S, Andrews R. Overview of Key Readmission Measures and Methods. 2012. HCUP Methods Series Report #2012-04. ONLINE December 20, 2012. U.S. Agency for Healthcare Research and Quality. Available: http://www.hcup- us.ahrq.gov/reports/methods/methods.jsp. TABLE OF CONTENTS OVERVIEW ............................................................................................................................... 1 MEASURE CHARACTERISTICS ............................................................................................... 2 Primary Purpose ..................................................................................................................... 2 Target Population ................................................................................................................... 3 Data Sources .......................................................................................................................... 3 Risk Adjustment of Rates ........................................................................................................ 3 DEFINING INDEX ADMISSIONS (DENOMINATORS) ............................................................... 3 Index Admissions ................................................................................................................... -
ACEC Guide to Returning to the Office and the Job Site
ACEC Guide to Returning to the Office and the Job Site Member Firms across the country are facing the challenge of returning to the workplace and the job site during the COVID-19 pandemic. The purpose of this resource is to help your firm respond to this challenge safely while managing legal risk. The Guide is divided into five sections: (1) Planning the Return; (2) Health Policy and Procedures; (3) Returning to the Office; (4) Returning to the Job Site; and (5) links to additional COVID-19 resources. It incorporates information from a number of sources, including the CDC, OSHA, FDA, private sector organizations both in and outside the engineering industry, and legal counsel. We hope the Guide will help your firm to navigate the “new normal” of working in the midst of an ongoing public health emergency. freepik.com www.acec.org #RescueRecoverRebuild 1 Table of Contents Section 1: Planning the Return Appoint Return to Work Team.................................................................................... 3 Determine Transition Plan..........................................................................................3 Determine Which Shelter-in-Place Laws and Orders Apply........................................3 Identify Who Returns to the Workplace/Job Site and When...................................... 3 Develop and Train in Workplace Policies and Other Practices.................................. 4 Consider Administrative Measures.............................................................................4 Transition from Telework