Quality System Basics Awareness of the Quality Policy, Manual, and QMS. ENT Version 2.0
|
|
|
- Juniper Gregory McGee
- 6 years ago
- Views:
Transcription
1 Quality System Basics Awareness of the Quality Policy, Manual, and QMS ENT Version 2.0
2 In this module you will learn MDT Quality Policy Location of the Quality Manual and Quality Documents Definition of the Quality Management System (QMS) Regulations and Standards we must follow Difference between a Paying vs. Permitting Customer Common Quality Acronyms Impact of Not Following Procedures 2 MDT Confidential
3 Quality Policy The policy is displayed in various locations around the facility and on specific badge cards. 3 MDT Confidential
4 Quality Manual and QMS The Quality Manual describes the Quality Management System (QMS), including quality procedures and quality related activities used by Medtronic Xomed, employees, operations, products and facilities located in Jacksonville, Florida and Mystic, Connecticut. The QMS is a process based system that takes system inputs from customers that are used for product development, manufacturing, distribution and servicing, and then monitors and analyzes feedback from customers as improvement input into the QMS and/or product. 4 MDT Confidential
5 Regulations and Standards The QMS provides activities that meet the requirements of the following laws, regulations and/or industry standards: U.S. FDA Quality Systems Regulations (QSR) European Communities Directive 93/42/EEC Medical Devices Canadian Medical Device Regulations ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. Japanese Quality Management System Ordinance (MHLW Ministerial Ordinance No. 169) Medtronic Corporate Policies and other applicable quality system regulations or standards. Specific Regulations and Standards 21CFR Part 820 Code of Federal Regulations (Sec. 820.XX) U.S. Law that governs Medical Devices Also referred to as Good Manufacturing Practices (GMPs) ISO International Standard Rules to sell and produce in Europe. Governs Medical We must follow all laws, regulations, and/or industry standards! 5 MDT Confidential
6 Paying vs. Permitting Customer When we think about our overall types of customers, we have two types: The paying customer (e.g. Doctors, Patients) Buy and pay for products Keep us in business The permitting customer (e.g. FDA) Certify our products and processes Allow (permit) us to do business 6 MDT Confidential
7 Quality Acronyms SOP Standard Operating Procedure This is just a short list of the numerous acronyms used around the organization! SSOP Sector Standard Operating Procedure QCFM Quality Controlled Form FDA Food and Drug Administration Additional Mystic Acronyms: PR Product Specification LS Label Specification MS Material Specification CFR Code of Federal Regulations (21 CRF 820) ISO International Organization for Standardization (ISO 13485) TM Test Method PS Process Specification GMP Good Manufacturing Practices 7 MDT Confidential
8 Where can I find SOPs SSOPs QCFMs PRs, TMs, LSs, MSs Quality Manual and Policy Agile: 8 MDT Confidential
9 Impact of Not Following Procedures (NFP) We have procedures (i.e. SOPs) in place for many important reasons. One reason is to ensure quality and consistency in the products we design, manufacture, and deliver to the customer. When procedures are not followed (and in the order they are designed too) we can cause harm to the company and most importantly to our patients. The cost to society for people not following procedures is enormous. Personal and Financial Information Exposed Safety, Injury, and/or Death The cost to a company for an individual not following procedures can be extremely high. FDA Fines Production Stopped Facility Closure 9 MDT Confidential
10 What can I do? FOLLOW THE PROCEDURE Compare the procedure to the work actually being performed Notify your supervisor if there are differences. It s Everyone s Responsibility! 10 MDT Confidential
11 What if I don t follow the procedure? Process for Violations Compliance is Mandatory Adherence to the Quality Management System (QMS) is a condition of employment for all Jacksonville and Mystic employees Violations will be handled promptly 11 MDT Confidential
12 Factual Determination/Investigation Process Failure to follow Procedure Investigation Quality System Training Resources If there is a suspected violation, the Department Manager and Human Resources will conduct an investigation to determine the root cause. The investigation will review the Quality System, Training, Resources, and/or Personal Responsibility (e.g. employee chose not to follow the procedure) as the possible cause. Depending on the outcome, the disciplinary process may be initiated. Personal Responsibility Disciplinary Process 12 MDT Confidential
13 Factual Determination/Investigation The goal is to find and correct system issues. The investigation seeks to identify: General facts Employee s explanation Employee s awareness of QMS requirements Factors outside the employee s control Was violation willful or inadvertent? Did violation increase risk or patient safety? Did violation increase regulatory or legal risks? Does employee have history of prior violations? Investigation team determines if violation occurred. If so, disciplinary action is taken 13 MDT Confidential
14 Suspected Violation Disciplinary Actions: As determined to be appropriate, an employee who is found to have violated the QMS may be subject to any of the disciplinary actions outlined below, up to and including immediate termination: Verbal Warning/Coaching First violation appears to be inadvertent and is determined not to have given rise to a risk to patient safety or material legal or regulatory risk for Medtronic. Not documented. Written Warning gave rise to a risk to patient safety or material legal or regulatory risk for Medtronic, second warning within past 24 months; and is determined to have been a knowing or willful violation. Suspension is preceded at any time by a written warning for any prior violation within past 24 months; resulted in a substantial risk to patient safety or substantial legal or regulatory risk for Medtronic, is determined to have been a knowing or willful violation. Termination is preceded at any time by a suspension; gave rise to a severe risk to patient safety or serious legal or regulatory risk for Medtronic; is determined to have been a knowing or willful violation. 14 MDT Confidential
15 Summary The Quality Management System is in place to meet the requirements of particular laws, regulations, and/or industry standards (such as QSR and ISO). The Quality Manual, Policy, and Documents (e.g. SOPs and QCFMs) can be found on the Agile Portal. Not following procedures can have a large negative impact on society and the company. All employees should be aware and follow the Quality Policy are responsible for following established procedures and notifying management of any differences must adhere to the Quality Management System (QMS) For more information: Review the Quality Manual Contact your manager, Human Resources, and/or Compliance Dept. 15 MDT Confidential
CAPA Management: Best Practices and FDA QSR Mandate WHITE PAPER. ComplianceQuest In-Depth Analysis and Review
CAPA Management: Best Practices and FDA QSR Mandate WHITE PAPER ComplianceQuest In-Depth Analysis and Review CAPA Management: Best Practices and FDA QSR Mandate Establishing a corrective and preventive
The Impact of Quality Culture on Quality Risk Management. FDA Perspective on Quality Culture; how it Impacts Risk Management
The Impact of Quality Culture on Quality Risk Management FDA Perspective on Quality Culture; how it Impacts Risk Management Teresa Gorecki Practice Lead Compliance Architects Agenda The WHAT Definitions
Privacy and Information Security Sanction Policy
Effective Date: November 2018 Policy Statement Privacy and Information Security Sanction Policy All workforce members, including faculty, staff, and students, are expected to comply with the organization
Progressive Discipline
Progressive Discipline A Management Perspective Basic Parameters Manager should be familiar with: Any applicable collective bargaining agreements Organizational personnel policies, civil service rules,
FOOD AND DRUGS AUTHORITY GUIDELINES FOR CONDUCTING PHARMACOVIGILANCE INSPECTIONS
FOOD AND DRUGS AUTHORITY GUIDELINES FOR CONDUCTING PHARMACOVIGILANCE INSPECTIONS Document No. : FDA/SMC/SMD/GL-PVI/2013/02 Date of First Adoption : 1 st February, 2013 Date of Issue : 1 st March, 2013
Safety compliance: Address OSHA requirements and get employees on board
Safety compliance: Address OSHA requirements and get employees on board As an employer, you probably know you need to comply with a variety of workplace safety rules. The federal Occupational Safety and
ROLE OF THE RESEARCH COORDINATOR Investigational New Drug Application-Sponsor Responsibilities 21CFR Part , subpart D
Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Investigational
Medical Device Communiqué
Medical Device Communiqué Q2 2013 Demonstrating the Safety of Medical Devices in the Human Body 1 DOJ: The Focus is on GMPs in 2013 2 ROHS II Impacts Medical Device Companies 3 Demonstrating the Safety
Sharp HealthCare s 2017 Compliance Education. Compliance and Ethics Module 1
Sharp HealthCare s 2017 Compliance Education Compliance and Ethics Module 1 1 Learning Objectives In this module you will learn about the following: Sharp HealthCare s Compliance and Ethics Program The
1.0 SAFETY PROGRAM OVERVIEW
1.0 SAFETY PROGRAM OVERVIEW 1.1 PURPOSE It is the policy of W. W. Gay Mechanical Contractor, Inc. to strive for the highest safety standards on our projects. Safety does not occur by chance. It is the
Chapter 10: Disciplinary Policy. or that results in unacceptable performance. Disciplinary action is to be in proportion
Chapter 10: Disciplinary Policy Section 10-1: Policy It is the policy of the County to discourage behavior that violates rules, policies, procedures, acceptable standards of ethical conduct, regulations,
Optimize Your Field Safety Corrective Actions Systems
Optimize Your Field Safety Corrective Actions Systems Patrick Caines, Ph.D. Baxter Healthcare 9 December 2016 1 Agenda International regulatory requirements and expectations for FSCA and recalls Developing
Prevent Quality System Deficiencies by Conducting Effective Internal Audits. Whitepaper
Prevent Quality System Deficiencies by Conducting Effective Internal Audits Whitepaper An internal audit system is one of the most effective ways to monitor, analyze, control, and improve quality management
The Theranos 483s. What can we learn? David Amor, MS, CQA Principal, Medgineering
The Theranos 483s. What can we learn? David Amor, MS, CQA Principal, Medgineering www.medgineering.com david@medgineering.com @Medgineering The good. The bad and the ugly. What can we learn? 2006. The
2015 > Soft Computer Consultants, Inc. 4/30/15
Page 1 of 7 U.S. Food and Drug Administration Protecting and Promoting Your Health Soft Computer Consultants, Inc. 4/30/15 SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFO
Medicare Parts C and D General Compliance Training
Medicare Parts C and D General Compliance Training Developed by the Centers for Medicare & Medicaid Services Martin Health System Annual Compliance Education Rev. 10/2016 PREFACE The Centers for Medicare
Medical Device Purchasing Controls Challenges of Compliance in a World Market June, 2013 OMTEC
Medical Device Purchasing Controls Challenges of Compliance in a World Market June, 2013 OMTEC - 2013 Quality Business Acceptance Activities 1 ..FDA Across the Globe.. 2 ..Warning Letters and FDA 483 update..
Effective Date Chapter 4 PROGRESSIVE DISCIPLINE
Effective Date Chapter 4 July 9, 2003 AUTHORITY PROGRESSIVE DISCIPLINE This guideline draws from concepts and principles included in Article III, Section 3.01 (3) and (12) of the City Charter; Sections
1 PROCEDURE S OBJECT 2 PROCEDURE S SCOPE 3 RESPONSIBILITIES AND AUTHORITIES
SOP FOR THE DECLARATION OF NON COMPLIANCE, DEVIATION, VIOLATION, UNEXPECTED EVENTS OCCURRING DURING AN EXPERIMENT. N : AAHRPP-SOP-040 / REV005 N ENGLISH VERSION : 108 "Please do take into account that
Corporate Safety Policies and Procedures
Safety & Health Program Corporate Safety Policies and Procedures 10627 Midwest Industrial Boulevard, St. Louis, MO Phone: 314-785-6425 Fax: 314-785-6426 Many companies involved in construction have written
API EUROPEAN GMP REQUIREMENTS. Alessio Ferrari
API EUROPEAN GMP REQUIREMENTS Alessio Ferrari SUMMARY GUIDELINES IMPLICATIONS FOR THE INDUSTRY ARTICLE 46 (F) OF DIRECTIVE 2001/83/EC PART I EU GMP Chapter 5 OFFICIAL MEASURES TO PROTECT. PROCEDURE TO
Introduction. Module Objective
Introduction Managing Safety and Health Time: About two hours, Objectives: 1: Explain the importance of an effective health & safety program 2: Explain worker rights to a safe & healthful workplace 3:
DRUG FREE WORKPLACE. Objective: To provide a safe and healthful environment for patients and employees.
Objective: To provide a safe and healthful environment for patients and employees. Policy: UHS policy prohibits the unlawful use, manufacture, possession, distribution or dispensing of drugs ("controlled
FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru
FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru FDA QSR (21 CFR Part 820) ISO 13485:2016 820.1 Scope 1 Scope 2 Normative References 820.3 Definitions 3 Terms and Definitions
Quality Management in PV. Andrea Lohée, Pharm-AD DCVMN training on PV, May 2017
Andrea Lohée, Pharm-AD DCVMN training on PV, May 2017 - Pharmacovigilance System - Overall Quality objectives in PV - Quality Management System overview - Quality Management System requirements - Quality
Course Outline for ISO 19011:2002 QMS & EMS Auditor
Course objective Course Outline for ISO 19011:2002 QMS & EMS Auditor The auditor training program is based on ISO 19011:2002, which is a guideline document for auditing and implementing quality systems
Subject: Definitions: None.
Office of Human Resources Standard Operating Procedure HR SOP #403 Subject: Employee Discipline Effective Date: November 16, 2012 Policy Statement: The purpose of this document is to establish a disciplinary
ISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes. Theresa McCarthy
ISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes Theresa McCarthy Welcome and Introductions Please interview and collect: Name Primary Quality Management
Medtronic XOMED PURPOSE SCOPE ASSOCIATED DOCUMENTS Applicable Documents SOP 037 SOP 040 QCFM 293 Corporate Procedure 035-P295 Reference Documents
Medtronic XOMED S.O.P. 359 Rev. N Ref. 7.5.3 Page 1 of 5 1.0 PURPOSE: 1.1 The purpose of this procedure is to provide for a system and instructions, to assign responsibilities and to meet the requirements
GCP Basics - refresher
p. 01 GCP Basics - refresher Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues Brief History of GCP 3 Brief History
GUIDE TO STUDENT EMPLOYMENT:
GUIDE TO STUDENT EMPLOYMENT: Information for New Hires and Returning Student Staff DRURY UNIVERSITY Human Resources 1 Table of Contents Imporatant Contact Information...3 Purpose of this Guide.4 Getting
DOCUMENT REVISION HISTORY PAGE. 90C0010 X 2 of 20. Revision History Of Document
DOCUMENT REVISION HISTORY PAGE Document Number: Rev: Page: 90C0010 X 2 of 20 Title: Corrective and Preventive Action Rev Revision History Of Document CO Number Description of Change Author Effective Date
Duplin County Alcohol and Drug-free Workplace Policy Adopted
Duplin County Alcohol and Drug-free Workplace Policy Adopted 9-21-09 Purpose and Goal Duplin County is committed to protecting the safety, health and well being of all employees and other individuals in
BEHAVIOUR ON SAFE SITES
Page: 1 of 8 P932 (a) Introduction: Black & Veatch has set a target of achieving ZERO incidents and injuries across all of its business operations. At B&V, we believe that zero incidents and injuries are
BSS Disciplinary Policy
BSS Disciplinary Policy 1. Introduction This document contains British Ski and Snowboard s (BSS) disciplinary policy. It sets out standards of conduct for employed & voluntary personnel & coaches and athletes
R&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Trial Closure and End of Trial SOP021 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration
Workplace Health & Safety Policy
Workplace Health & Safety Policy Labour Solutions Australia is one of Australia s leading workforce management and labour hire companies. Labour Solutions Australia is committed to providing a safe work
Disciplinary Action Policy
Town of Chapel Hill, NC Personnel Policy Policy Number: PP 5-3 Effective Date: 09/01/2015 Modified: 12/18/2015 08/05/2016 I. POLICY II. PURPOSE III. PROCEDURE IV. FORMS/INSTRUCTIONS V. ADDITIONAL CONTACTS
Progressive Discipline Policy
Progressive Discipline Policy Purpose. To establish rules pertaining to employee conduct, performance, and responsibilities so that all personnel can conduct themselves according to certain rules of good
Discipline and Dismissal Policy
The Management of Drakes Supermarkets is committed to a staff discipline and dismissal policy that complies with the principles of fairness as set out in the Fair Work Act 1994 (SA), the Industrial Relations
Dalton State College Progressive Discipline Policy for Staff May 13, 2013
Policy A system of progressive discipline may be used to encourage an employee to correct unacceptable behavior and to adhere to existing Dalton State College Policies & Procedures. Dalton State College
Code of Ethics for Senior Financial Officers
Code of Ethics for Senior Financial Officers Department Issuing Code: Corporate Compliance Executive Sponsor: Chief Compliance Officer, Black Knight, Inc. Code Owner: Chief Compliance Officer, Black Knight,
Medtronic XOMED PURPOSE SCOPE ASSOCIATED DOCUMENTS Applicable Documents SOP 037 SOP 040 QCFM 293 Corporate Procedure 035-P295 Reference Documents
Medtronic XOMED S.O.P. 359 Rev. O Ref. 7.5.3 Page 1 of 5 1.0 PURPOSE: 1.1 The purpose of this procedure is to provide for a system and instructions, to assign responsibilities and to meet the requirements
MODULE I: MEDICARE & MEDICAID GENERAL COMPLIANCE TRAINING
MODULE I: MEDICARE & MEDICAID GENERAL COMPLIANCE TRAINING 2 0 1 4 A Message From Our CEO and Compliance Officer At PacificSource, we pride ourselves on maintaining a culture of compliance and high ethical
Temple University. Rules of Conduct
Temple University Rules of Conduct Disclaimer The Temple University Employee Manual sets forth the expected standards of conduct and performance of Temple University employees. The official copy of policies
Carolina Hearts Medical Equipment, LLC
EMPLOYMENT APPLICATION Referred By: Date OFFICE USE ONLY Human Resource Representative Application Received Last Name First Middle Application Reviewed Interview Job Offer Date Start Salary Position Applied
Performance Management, Employee Discipline and Termination of Employment Effective Date: 06/29/2015 Last Revision Date: 06/29/2015
SOP Title: Performance Management, Employee Discipline and Termination of Employment Effective Date: 06/29/2015 Last Revision Date: 06/29/2015 The following has been defined by Tavistock Restaurant Collection
MDSAP AUDIT PROCESS. A Manufacturer s Perspective. Connie Hoy EVP Regulatory Affairs Cynosure, Inc.
MDSAP AUDIT PROCESS A Manufacturer s Perspective Connie Hoy EVP Regulatory Affairs Cynosure, Inc. Cynosure Located in Westford, MA Largest manufacturer of Medical Lasers Second location in Hicksville,
Merge Healthcare, Inc. 9/30/15
Page 1 of 5 U.S. Food and Drug Administration Protecting and Promoting Your Health Merge Healthcare, Inc. 9/30/15 Department of Health and Human Services Public Health Service Food and Drug Administration
Accountability in a Safety Culture. Berry Bairrington, OHST
Accountability in a Safety Culture Berry Bairrington, OHST OUTLINE Who is responsible for safety at your organization? Safety Culture: Are your leaders engaged? Principals for leaders to foster safety
SECTION 2. Recordkeeping. Counseling and Corrective Action Training Module 05/18/18
SECTION 2 Recordkeeping 1 Recordkeeping Performance management must be documented. This section seeks to outline what is to be documented and how it is to be done. The primary goal of proper documentation
Safety reporting requirements in the post marketing phase. Pharmacovigilance Specialty Committee SQA Conference March 2017 Washington
Safety reporting requirements in the post marketing phase Pharmacovigilance Specialty Committee SQA Conference March 2017 Washington DISCLAIMER These materials have been prepared solely for educational
The Company seeks to comply with both the letter and spirit of the laws and regulations in all jurisdictions in which it operates.
1. Policy Statement CRC HEALTH GROUP, INC. CRC HEALTH CORPORATION CODE OF BUSINESS CONDUCT AND ETHICS It is the policy of CRC Health Group to conduct its business affairs honestly and in an ethical manner.
CBS Television Studios Roles and Responsibilities
Responsibilities In order to ensure a safe working environment and production, each supervisor, manager and employee is obligated to uphold the safety guidelines set forth in the CBS Television Studios
B&B Gas Well Services, LLC Health, Safety and Environmental Manual DISCIPLINARY POLICY
B&B Gas Well Services, LLC Health, Safety and Environmental Manual DISCIPLINARY POLICY 1 DISCIPLINARY POLICY Table of Contents Topic Page 1.0 Objective 3 2.0 Scope 3 3.0 References 3 4.0 Training 3 5.0
Jose Giron 5/19/16. Protecting and Promoting Your Health. Public Health Service Food and Drug Administration Silver Spring, MD WARNING LETTER
U.S. Food and Drug Administration Protecting and Promoting Your Health Jose Giron 5/19/16 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993
3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor.
SOP #: RCO-100 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational New Drug Application (IND) and who is the Sponsor of the research has additional responsibilities
JUN WARNING LETTER
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service JUN 2 8 2006 WARNING LETTER Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 VIA FEDERAL EXPRESS Scott A. Spiro, MD 101 Old
Rogue Community College and Oregon School Employee Association Chapter 152. Classified Employee Discipline Manual
Rogue Community College and Oregon School Employee Association Chapter 152 Classified Employee Discipline Manual Revised November 1, 2014 PREAMBLE The Progressive Discipline Manual (PDM) is intended to
1.4. Ermha adheres to a progressive discipline approach as a means of ensuring a method which is fair and responsive.
PURPOSE 1.1. Ermha is committed to providing a high quality system that supports Ermha s organisational objectives, vision and mission and does so through linking those objectives with staff goals, achievements
Software Recalls Issues and Challenges
ASQ: Meeting the Compliance Challenge Perspectives from Government, Industry and Quality Professionals: April 28, 2010 Software Recalls Issues and Challenges Jeme Wallace Director Regulatory Affairs GE
Annual Research Administrators Symposium IRB Compliance. Thursday, July 31, 2014
Annual Research Administrators Symposium IRB Compliance Thursday, July 31, 2014 Why IRB Compliance Is Required for Grant Submissions Topics to Cover Today What is an IRB? Why IRB review is required? Regulatory
Assume that any action you take could ultimately be publicized, and consider how you and PCA would be perceived. When in doubt, stop and reflect.
CODE OF ETHICS ( Code ) 8.1 Purpose The purpose of the Code of Ethics and Business Conduct is to set forth basic principles to guide you in your day-to-day activities as an employee, officer, or director
GCP Convergence Improves Transportability of Medical Device Clinical Data
GCP Convergence Improves Transportability of Medical Device Clinical Data By Harmonization-by-Doing Working Group 4 The safety, performance and effectiveness of medical devices are often evaluated by well-controlled
date: 7/12 Rev: 8/12 Approval: dept: HR Executive Director page: 1 of 5
CALIFORNIA STATE UNIVERSITY FULLERTON, AUXILIARY SERVICES CORPORATION Standard Procedure TITLE VOLUNTARY AND INVOLUNTARY TERMINATION POLICY date: 7/12 Rev: 8/12 Approval: dept: HR Executive Director page:
3 14. Drug Abuse and Controlled Substances
3 14. Drug Abuse and Controlled Substances Vectrus will not tolerate illegal drugs, controlled substances or alcohol abuse and will take all reasonable steps to ensure that drug and alcohol abuse does
DRUG AND ALCOHOL-FREE WORKPLACE POLICY
DRUG AND ALCOHOL-FREE WORKPLACE POLICY Mister Car Wash (MCW) is committed to protecting the safety, health and well-being of all employees and other individuals in our workplace. Drug and alcohol use pose
Postmarketing Safety Reporting and cgmp Requirements for Combination Products. Katlin McKelvie Backfield November 2, 2017
Postmarketing Safety Reporting and cgmp Requirements for Combination Products Katlin McKelvie Backfield www.backfieldpllc.com November 2, 2017 Background: What is a Combination Product? Combination product:
Journal home page: RESEARCH ARTICLE
Journal home page: http://www.journalijiar.com INTERNATIONAL JOURNAL OF INNOVATIVE AND APPLIED RESEARCH RESEARCH ARTICLE QUALITY AUDIT AND GMP INSPECTION OF PHARMACEUTICAL INDUSTRY WITH REFERENCE TO USFDA;
A. Code of Conduct Code of Conduct and Disciplinary Actions 3/8/2016
OFFICIAL POLICY 9.1.2 Code of Conduct and Disciplinary Actions 3/8/2016 THE LANGUAGE USED IN THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT BETWEEN EMPLOYEES AND THE COLLEGE OF CHARLESTON. THIS DOCUMENT
SHRINERS HOSPITALS FOR CHILDREN CORPORATE COMPLIANCE PLAN
SHRINERS HOSPITALS FOR CHILDREN CORPORATE COMPLIANCE PLAN 1.0 INTRODUCTION Shriners Hospitals for Children ( SHC ) is committed to conducting itself according to applicable business ethical standards and
SECTION 24 DISCIPLINE
SECTION 24 DISCIPLINE A. PURPOSE: To provide guidance regarding disciplinary action being taken against career service employees and to outline the procedure that must be followed when imposing discipline.
Food Fight: FSMA and the FDA s New Era of Enforcement. July By Sandra J. Wunderlich
Food Fight: FSMA and the FDA s New Era of Enforcement July 2017 By Sandra J. Wunderlich Panelists: Michael Landa, Retired Director, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Documenta tion and Records
Documenta tion and Records Page 1 of 30 Training Outcome of the Module: After completing this module, you will be able to: Recognize the importance of procedures Recognize the importance of record keeping
The Convergence of Software in the Medical Device Industry. Joseph Azary
The Convergence of Software in the Medical Device Industry Joseph Azary 203-944-9320 Info@azarytech.com FDA Regulations & Quality Requirements Clinical Sterilization FDA Regulations & Quality Requirements
SFCC EMPLOYEE CORRECTIVE ACTION AND DISCIPLINARY ACTION POLICY 4-2
SFCC EMPLOYEE CORRECTIVE ACTION AND DISCIPLINARY ACTION POLICY 4-2 Policy Overview SFCC strives to provide a safe and harmonious work environment where employees are able to perform their work productively
LIBERTY Dental Plan General Compliance Training
LIBERTY Dental Plan General Compliance Training 1 IMPORTANT NOTICE IMPORTANT NOTICE This training module will assist Medicare Parts C and D plan Sponsors in satisfying the Compliance training requirements
Drug Testing In The Workplace
Drug Testing In The Workplace Drug Testing In The Workplace Under Texas and federal laws, there is almost no limitation at all on the right of private employers to adopt drug and alcohol testing policies
Speak Up & Reporting Policy of AMG ADVANCED METALLURGICAL GROUP N.V. Strawinskylaan XX Amsterdam The Netherlands
Speak Up & Reporting Policy of AMG ADVANCED METALLURGICAL GROUP N.V. Strawinskylaan 1343 1077 XX Amsterdam The Netherlands Speak Up & Reporting Policy At AMG Advanced Metallurgical Group ( AMG ) we all
This means making sure that all employees understand what the law requires and act accordingly.
Competition Law and Anti Competitive Practices Policy Introduction The Bathroom Brands Group Limited (the Company ) is committed to compliance in full with all laws and regulations governing its businesses
ADMINISTRATIVE PROCEDURE. Number IV-1
ADMINISTRATIVE PROCEDURE SUBJECT: DISCIPLINARY PROCEDURES Number IV-1 Effective Date: Issued: 2/13/87 Revised: 11/15/00 Page 1 of 8 PURPOSE: To outline procedures and policies relating to employee counseling,
IDENTIFYING & MANAGING GCP COMPLIANCE RISKS FOR THE PHARMACEUTICAL, BIOTECH & DEVICE INDUSTRIES
IDENTIFYING & MANAGING GCP COMPLIANCE RISKS FOR THE PHARMACEUTICAL, BIOTECH & DEVICE INDUSTRIES Karen Weaver Epstein, Becker & Green Health Care & Life Sciences Practice APPLICABLE REGULATIONS 21 CFR 312
WARNING LETTER AUG 3, 2016
Ropack, Inc. 8/3/16 Department of Health and Human Services Public Health Service Food and Drug Administration 10903 New Hampshire Avenue White Oak Building 66 Silver Spring, MD 20993 WARNING LETTER AUG
Quality Assurance QA STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits
Quality Assurance QA 601.01 STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick
RELM WIRELESS CORPORATION (the Company ) CODE OF BUSINESS CONDUCT AND ETHICS
RELM WIRELESS CORPORATION (the Company ) CODE OF BUSINESS CONDUCT AND ETHICS Introduction This Code of Business Conduct and Ethics covers a wide range of business practices and procedures. It does not
Your Guide to the Compliance Process
Your Guide to the Compliance Process Our Commitment and Your Responsibilities Disciplinary Action Guidelines Guidance for Managers Investigations Process Overview US Reporting Process Overview Corporate
Safety Program. For Packaging, Manufacturing, Distribution
Safety Program For Packaging, Manufacturing, Distribution SAFETY PROGRAM Clarification This document is provided only as a guide to assist employers and employees in developing a Safety Program designed
LOCK OUT/ TAG OUT PROGRAM
INTRODUCTION Purpose: This program is established to enhance employee safety by identifying procedures for affixing appropriate lockout or tagout (herein after LOTO) devices to energy isolating devices,
CERTIFIED MAIL RETURN RECEIPT REQUESTED
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 NOTICE OF INITIATION OF DISQUALIFICATION PROCEEDINGS AND OPPORTUNITY
The Organizational Integrity Program
The Organizational Integrity Program Supporting Right Relationships SJMHS New Associate Orientation 1 Overview Integrity Why is this important? Standards of Conduct Supporting Right Relationships Key Areas:
Allergy Laboratories, Inc. 10/4/13
Allergy Laboratories, Inc. 10/4/13 SEP 04, 2013 Department of Health and Human Services Public Health Service Food and Drug Administration Office of Regulatory Affairs 12420 Parklawn Drive ELEM-2152 Rockville,
Discipline for Unsafe Practices. Betsy Reeve Reeve Shima PC, (206) April 6, 2017
Discipline for Unsafe Practices Betsy Reeve Reeve Shima PC, ereeve@reeveshima.com (206) 624-4004 April 6, 2017 Why, When and How can a school district discipline an employee for unsafe acts? WHY: The Role
Generally, there are three conditions leading to the need for discipline at Tennessee State University. They are:
PERSONNEL Personnel Disciplinary Procedures (Non-Faculty) (6.12) PURPOSE The purpose of this policy is to establish a disciplinary process which will provide consistency in application and equitable treatment
INTRODUCTION TO ISO 9001:2015. A One-Day Awareness On ISO 9001:2015 Quality Management Systems And The Impact On The Work Place
Course no.: ISO 01 INTRODUCTION TO ISO 9001:2015 A One-Day Awareness On ISO 9001:2015 Quality Management Systems And The Impact On The Work Place What is Quality What is ISO 9001:2015 a Quality Management
UCLA Procedure 615.1: Employee Driving Records
UCLA Procedure 615.1: Employee Driving Records I. REFERENCES Issuing Officer: Administrative Vice Chancellor Responsible Dept: Transportation Fleet & Transit Effective Date: May 9, 2008 Supersedes: UCLA
UPPLIER ANUAL. Issued: 01 Aug 13
UPPLIER ANUAL Issued: 01 Aug 13 Table of Contents Our Company 3 Our Vision 3 Scope and Purpose 4 Responsibilities 4 General Expectations and Requirements 5 Supplier Quality Management System 6 Supplier
Any fraudulent information provided on this application will be cause for rescinding any and all WC benefits.
This package contains the following documents: Employment Application Accidents and Injuries Procedures Substance Abuse Policy Drug and/or Alcohol Testing Consent Form Form I-9 Form W-4 Completion of this
COMPANY ORIENTATION POLICIES AND PROCEDURES
Your next move matters, make it count! COMPANY ORIENTATION POLICIES AND PROCEDURES Congratulations, with this assignment, you are now an employee of ADVANCE CAREER SERVICES (ACS), an Equal Opportunity
Positive Corrective Action
Positive Corrective Action THIS POLICY REPLACES POLICY Policy Number: 501 Policy Number: 501 Effective Date: 9/26/2017 Effective Date: 11/1/2002 PAGE: 1 of 5 Policy: It is the policy of Wesley Woods Senior
Lessons from Pharmaceutical Laboratory related FDA Warning Letters
Lessons from Pharmaceutical Laboratory related FDA Warning Letters The Agilent Critical Compliance Seminar 2016 Ludwig Huber Ludwig_huber@labcompliance.com Overview FDA Inspections and reports GMP compliance