Addressing Key FDA Citations with Training. Align UL EduNeering Courses to Top FDA Warning Letter Topics
|
|
- Nicholas Black
- 6 years ago
- Views:
Transcription
1 Addressing Key FDA Citations with Training Align UL EduNeering Courses to Top FDA Warning Letter Topics
2 Addressing Key FDA Citations with Training Align UL EduNeering Courses to Top FDA Warning Letter Topics This paper recommends specific UL EduNeering online courses from our FDA Inspection and Enforcement Library, as well as our GMP Medical Device Library, that cover the most cited Warning Letter topics from FDA inspectors to Medical Device companies. Many of the courses noted here are authored by the FDA, as well as EduQuest, a leading Life Science regulatory consulting firm, and David C. Peterson, UL s subject matter expert in the interrelated fields of organizational development, Good Manufacturing Practices (GMPs) and curriculum development. Identifying the GMP/QSR Deficiency Topics This paper is based on an analysis of the FDA Warning Letter topics sent to Medical Device companies (in cgmp/qsr/manufacture subject) from August to December In all, 112 deficiencies were identified where inspectors noted that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the current Good Manufacturing Practice (cgmp) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. UL provides courses that focus on these topics so quality and auditing teams can understand the expectations of the FDA. Here are the 8 most cited subjects (ranked from highest to lowest, listed with the percentage of instances) and our suggested courses. Page 2
3 1. Corrective and Preventive Action (15%) Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR (a). Key Topics QSIT 4 The Corrective and Preventive Actions Subsystem (FDA53): This course is one in a series of four written by the FDA for inspectors on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting Medical Device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course covers the inspectional objectives related to the Corrective and Preventive Actions subsystem. QS Regulation 7: Corrective and Preventive Action (QSR07): The seventh in a series of Quality System (QS) Regulations, this course focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart J). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The intent of 21 CFR is to correct or prevent poor practices, not simply to correct or prevent bad products. Correction and prevention of unacceptable quality system practices should result in fewer nonconformities related to products. Learners will become familiar with a manufacturer s responsibilities relative to the corrective and preventive action requirements of the QS Regulation. 2. Complaint Management (6%) Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). Identifying the GMP/QSR Deficiency Topics 1. Corrective and Preventive Action (15%) 2. Complaint Management (6%) 3. Document Control (6%) 4. Device History Record (5%) 5. Design Control (5%) 6. Design Validation Procedures (4.5%) 7. Training (3%) 8. Quality Audits (3%) FDA-Authored QSR Library Complaint Management for Medical Device Manufacturers (DEV46): This course reviews the importance of properly responding to reports of alleged medical device problems. The learner will be able to apply the knowledge acquired to handle complaint events in a manner that is compliant with FDA regulations. Learners will understand the FDA s definition of a complaint, effective complaint handling systems, including CAPA, and steps for investigating a complaint. Page 3
4 Special Investigations (FDA25): This course provides an overview of the broad spectrum of investigations performed by the FDA. These investigations include consumer complaints, disaster investigations, surveillance, health care fraud, tampering and criminal investigations. Learners will be able to identify the purpose of special investigations. You will also learn the properties of special investigations, as well as what to look for during each of these investigations. 3. Document Control (6%) Your firm failed to adequately document acceptance activities for finished devices as required by 21 CFR (e). QS Regulation 4 (QSR04): Document and Purchasing Controls: this course focuses on the Document Controls requirements of 21 CFR Part 820, Subpart D and the Purchasing Controls requirements of 21 CFR Part 820, Subpart E. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Design Control Regulations for Medical Device Manufacturers (DEV40): This course introduces FDA design control regulations and provides basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file and human factors. This course focuses on the importance of documentation. 4. Device History Record (5%) Failure to maintain adequate device history records (DHR), as required by 21 CFR Our suggested course: QS Regulation 9: Records (QSR09): This course focuses on Records (21 CFR Part 820 Subpart M). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.... Page 4
5 One of the basic themes of the Quality System Inspection Technique is the Establish Test. The QS Regulation requires many procedures to be established and defines establish as define, document (in writing or electronically), and implement. Records play a vital role in the FDA s ability to confirm that procedures have been appropriately implemented and, on a broader scope, that an adequate and effective quality system has been established and maintained by the firm being inspected. 5. Design Control (5%) Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR Design Control Regulations for Medical Device Manufacturers (DEV40): This course introduces FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file and human factors. Records play a vital role in the FDA s ability to confirm that procedures have been appropriately implemented. QS Regulation 3: Design Controls (QSR03): This course explains the purpose of design control requirements. The learner will be able to identify the scope of the regulation and recognize requirements for design control procedures, planning, input and output, review, verification, validation, transfer, changes and the design history file. Manufacturers establish a system to control their design process so devices meet user needs, intended uses and specified requirements. The FDA believes that unless manufacturers apply appropriate design controls during development, a finished device may not be safe or effective for its intended use. Therefore, to comply with and implement the requirements of 21 CFR , Design Controls, manufacturers must adopt current and effective methods and procedures for designing devices. Page 5
6 6. Design Validation Procedures (4.5%) Failure to establish and maintain adequate procedures for validating the device design in order to ensure that devices conform to defined user needs and intended uses, and perform risk analysis where appropriate, as required by 21 CFR (g). Our suggested course: QSIT 3 Design Controls Subsystem (FDA52): This course provides guidance for inspecting Medical Device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course covers the inspectional objectives related to the Design Controls subsystem. Topics include: Beginning to inspect the Design Controls subsystem, the design plan review, the inputs and outputs of the design process, assessing acceptance criteria and Design Verification, Design Validation, and Completing the Design Controls subsystem inspection. 7. Training (3%) Failure to establish adequate procedures for identifying training needs for ensuring that all personnel are trained to adequately perform their assigned responsibilities and for documenting training, as required by 21 CFR (b). Our suggested course: FDA Training and Qualification Requirements (PHA67): This course focuses on an effective personnel training and qualification process, which can produce a competent workforce, leading to a reduction of errors/deviations, customer complaints, regulatory risk and operational costs. This course will identify FDA requirements concerning training and qualification, responsibilities of personnel, records that need to be maintained and how to measure training and qualification. 8. Quality Audits (3%) Failure to establish written procedures for a third party to conduct quality audits (21 CFR ). A third party is performing quality testing on the protective lens, but no procedures have been established for the third party firm. Principles of Auditing (PHDV69): This course focuses on the purpose and conduct of internal and external quality audits. It discusses the purpose of conducting audits, and focuses on the benefits to be derived if audits are conducted properly. It begins with a discussion on establishing an audit program to achieve internal GMP compliance. The course focuses on the actual preparation, conduct and follow-up associated with an internal audit. Page 6
7 Finally, the importance of establishing corrective action and follow-up and how these aspects of the audit program can yield opportunities and quality improvements will be illustrated. Learners will be able to discuss the importance of an effective audit program, the benefits that can result, actual conduct of an audit and how proper corrective action and follow-up yield the ultimate benefits of the program. Vendor Certification for Pharmaceutical Manufacturers (PHDV85): This course discusses the process of vendor certification a means of ensuring that a company is receiving the best possible materials, products and services from its vendors or suppliers. This course covers the common practices and concepts associated with vendor certification includeing vendor audits and testing. FDA-Authored QSR Library The FDA-authored QSR courses, included in both the GMP and FDA Inspection and Enforcement Libraries, reflect the FDA s most current requirements, priorities and policies in the areas of quality systems, import operations, medical device regulations, drug safety and more. The QS Regulation requires that each manufacturer shall establish and maintain a quality system that is appropriate for the specific device(s) designed or manufactured, and that meets the requirements of this part. If manufacturers do not implement certain GMP requirements which are qualified by the term where appropriate, they should document their justification for nonimplementation. The 11 QSR courses specify general objectives such as use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc., rather than methods, because a specific method would not be appropriate to all operations. This course will identify FDA requirements concerning training and qualification, responsibilities of personnel, records that need to be maintained, and how to measure training and qualification. Page 7
8 About UL EduNeering UL EduNeering is a business line within UL Life & Health s Business Unit. UL is a global independent safety science company offering expertise across five key strategic businesses: Life & Health, Product Safety, Environment, Verification Services and Enterprise Services. UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute. 202 Carnegie Center Suite 301 Princeton, NJ UL and the UL logo are trademarks of UL LLC uleduneering.com WP/11/120913/MD
Library Guide: Active Pharmaceutical
Library Guide: Active Pharmaceutical Ingredients (API) Table of Contents Overview...3 Sample Curriculum...5 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)...7 A Tour of the
More informationPhoto. Technology s Role in Improving SOP Management Processes
Photo Technology s Role in Improving SOP Management Processes Technology s Role in Improving SOP Management Processes Executive Summary As the industry faces increased globalization, product supply chain
More information10 "Must-Haves" for the Life Sciences Learning Management System
10 "Must-Haves" for the Life Sciences Learning Management System Why the Life Sciences LMS Needs to Demonstrate Record Control UL talks to many Life Sciences companies that are exploring learning and development
More informationGxP Auditing, Remediation, and Quality System Resourcing
GxP Auditing, Remediation, and Quality System Resourcing TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing
More informationPrevent 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
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 5 GLP Auditing 6 Pharmacovigilance Auditing 6 Vendor/Supplier Auditing 7
More informationASEPTIC PROCESSING COMPETENCIES
Improving Process and Performance Through ASEPTIC PROCESSING COMPETENCIES UL Aseptic Processing Solutions Solutions that Improve Efficiency & Productivity With regulatory agencies focusing on aseptic processing,
More informationComplianceWire COMPLIANCE MANAGEMENT FOR LIFE SCIENCES ORGANIZATIONS
ComplianceWire COMPLIANCE MANAGEMENT FOR LIFE SCIENCES ORGANIZATIONS COMPLIANCE. PROFICIENCY. PERFORMANCE. ComplianceWire, the best-in-class solution for regulated industries, is a powerful, Part 11 compliant
More informationISO FDA QSR. ISO and FDA QSR: A Step by Step Guide to Complying with Medical Device QMS Requirements
ISO 13485 FDA QSR ISO 13485 and FDA QSR: A Step by Step Guide to Complying with Medical Device QMS Requirements Jon Speer Founder & VP of QA/RA greenlight.guru Table of Contents 1 Introduction 4 QMS Philosophy
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing 8
More informationAAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 1
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward, Owner, Ward Sciences
More informationPurchasing Controls. FDA Small Business Regulatory Education for Industry (REdI) Conference Denver, Colorado May 13, 2015
Purchasing Controls FDA Small Business Regulatory Education for Industry (REdI) Conference Denver, Colorado May 13, 2015 LCDR Samantha Spindel, Ph.D. Premarket Programs Branch Division of Industry and
More informationFDA 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
More informationISPE Annual Meeting 29 October 1 November 2017 San Diego, CA. Combination Product Updates, Initiatives, and Case Studies. Steven B. Hertz, P.E.
Combination Product Updates, Initiatives, and Case Studies Steven B. Hertz, P.E. Consumer Safety Officer, FDA/CDER/OPQ Agenda 1: CP Overview 2: CDER Updates : CP Application Info : Case Studies 5: Summary
More informationLibrary Guide: CrossKnowledge Courses
Library Guide: CrossKnowledge Courses Overview: CrossKnowledge CEO, Mickaël Ohana stated, We are fortunate to partner with a company like UL, which is a leader in providing online regulatory compliance
More informationAAMI Quality Systems White Paper
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017, Updated February 2018 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward,
More informationThe 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
More informationCombination Products Part 4 Compliance and Implementation at multi-site Network
Combination Products Part 4 Compliance and Implementation at multi-site Network Vijay Damodaran Eli Lilly & Company September 27, 2017 Contents Key cgmp requirements for combination products How to perform
More informationChoices IEC rd Edition and Component Selection
Choices IEC 60601-1 3rd Edition and Component Selection Choices IEC 60601-1 3rd Edition and Component Selection Abstract When the 3rd edition of IEC 60601-1 was published, it marked the beginning of a
More informationHow Pharma Should Monitor itself for GMP Compliance & How FDA Inspections Could Incorporate Pharmaceutical Inspection Cooperation Scheme (PIC/S)
How Pharma Should Monitor itself for GMP Compliance & How FDA Inspections Could Incorporate Pharmaceutical Inspection Cooperation Scheme (PIC/S) ASQ Northeast Pharmaceutical GMP/Quality Conference January
More informationRole of Industrial Engineer in Compliance with FDA Regulations
Role of Industrial Engineer in Compliance with FDA Regulations Wanda J. Torres Medical Device Specialist Libia M. Lugo Drug Specialist Simposio de Ingeniería Industrial Polytechnic University, San Juan
More informationCombination products Updates Final FDA Guidance
Compliance Seminars Combination products Updates Final FDA Guidance Presented by Anna Lundén Webinar, March 8, 2017 Intentionally blank Compliance Seminars Our international course program for GMP professionals
More informationThe SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies
The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies By Rob Sims, UL Compliance to Performance When Life Sciences companies
More informationGMP The Other Side of Chemistry, Manufacturing & Controls (CMC)
Overview of USFDA Drug Regulatory Requirements Pharmaceutical Quality and Facility Inspections (GMP) Session II 19 February 2014 Casablanca, Morocco GMP The Other Side of Chemistry, Manufacturing & Controls
More information21 CFR Ch. I ( Edition) Personnel Design controls Identification Traceability.
Pt. 820 device together with an explanation of the basis for the estimate; (iv) Information describing the applicant s clinical experience with the device since the HDE was initially approved. This information
More informationEU and FDA GMP Regulations: Overview and Comparison
THE QUALITY ASSURANCE JOURNAL, VOL. 2, 55 60 (1997) EU and FDA GMP Regulations: Overview and Comparison The increasing emphasis on global supply of drug products, as well as starting materials and investigational
More informationQuality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 11 Status : APPROVED Effective: 09/07/2017 Page 2 of 32 Quality Manual Table of Contents
More informationMedical 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..
More informationJournal 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;
More informationFDA Initiatives and Regulatory Trends for Life Sciences. Larry Spears President L. Spears Consulting
FDA Initiatives and Regulatory Trends for Life Sciences Larry Spears President L. Spears Consulting Before We Begin If you experience technical problems, please contact GoToMeeting Technical Support at
More informationQUALITY MANUAL Revision H
QUALITY MANUAL Revision H JADE PRECISION MEDICAL COMPONENTS, LLC 3063 B Philmont Avenue Huntingdon Valley, PA 19006 Page: 1 of 15 Table of Contents 1. Purpose & Scope... 2 2. Applicable Standards... 2
More informationFood and Drug Administration, HHS Pt Sec Scope Definitions Quality system.
Food and Drug Administration, HHS Pt. 820 authorized designee. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm
More informationInfor CloudSuite Industrial
Infor CloudSuite Industrial Stay current with the shifting standards of FDA compliance For medical device manufacturers, advancing and maintaining information management solutions that are compliant with
More informationQUALITY SYSTEM MANUAL
QUALITY SYSTEM MANUAL This Manual is a Proprietary Document and any Unauthorized Reproduction is prohibited. ISSUE DATE July 26, 2012 AUTHORIZED BY: Quality Management Representative Eric Hoff Managing
More informationZOLL Document Number: 90E0004 Page 5 of 15 Maintenance of Quality Records
ZOLL Number: 90E0004 Page 5 of 15 1. INTRODUCTION 1.1 Purpose 1.2 Scope The purpose of this document is to provide guidance regarding the identification of a quality record and the documentation practices
More informationGUIDE TO INSPECTIONS OF QUALITY SYSTEMS
FOOD AND DRUG ADMINISTRATION GUIDE TO INSPECTIONS OF QUALITY SYSTEMS 1 1 August 1999 2 Guide to Inspections of Quality Systems This document was developed by the Quality System Inspections Reengineering
More informationPAI Inspections, Observations and Data Integrity
PAI Inspections, Observations and Data Integrity Krishna Ghosh, Ph.D. Office of Pharmaceutical Quality Office of Process and Facilities Center for Drug Evaluation and Research November, 2017 20 November
More informationCorrespondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements
Correspondence Between and 21 CFR Part 820 QMS Requirements 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158 262.842.1250 262.842.1240 info@rcainc.com rcainc.com 2 4 Quality Management System
More informationEPICOR, INCORPORATED QUALITY ASSURANCE MANUAL
EPICOR, INCORPORATED QUALITY ASSURANCE MANUAL Revision: 6 Date 05/18/09 EPICOR, INCORPORATED 1414 E. Linden Avenue P.O. Box 1608 Linden, NJ. 07036-0006 Tel. 1-908-925-0800 Fax 1-908-925-7795 Table of Contents:
More informationPharmaceutical Reference Standards: Overview and Role in Global Harmonization
Matthew Borer, Ph.D., Advisor Pharmaceutical Reference Standards: Overview and Role in Global Harmonization 3rd DIA China Annual Meeting Beijing, China, 16-18 May, 2011 What is a Pharmaceutical Reference
More informationGMP On Site Series. GMP Essentials
GMP On Site Series GMP Essentials GMP Basics Objectives 1. State the critical definitions of the pharmaceutical industry. 2. Describe the law as it applies to various critical functions. 3. State the history
More information21CFR11 Compliance and Automated Manufacturing
Presented at the World Batch Forum North American Conference Woodcliff Lake, NJ April 7-10, 2002 107 S. Southgate Drive Chandler, Arizona 85226-3222 480-893-8803 Fax 480-893-7775 E-mail: info@wbf.org www.wbf.org
More informationQuality Agreements with CMO s. Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality
More informationTHE COMPLETE GUIDE TO FDA-REGULATED SUPPLIER QUALIFICATION & QUALITY MANAGEMENT
THE COMPLETE GUIDE TO FDA-REGULATED SUPPLIER QUALIFICATION & QUALITY MANAGEMENT A risk-based approach to qualifying, managing and auditing third party providers TABLE OF CONTENTS 1 Outsourcing under greater
More informationCompliance & Validation Validation of Software-as-a-Service (SaaS Solutions)
www.arisglobal.com A White Paper Presented By ArisGlobal Compliance & Validation Validation of Software-as-a-Service (SaaS Solutions) ARIS GLOBAL CORPORATE HEADQUARTERS ArisGlobal, 1266 East Main Street,
More informationFDA Inspections. Purpose of an Inspection. FD&C Act Section 704(a): Factory Inspections 1. Authority to Inspect
Purpose of an Inspection FDA Inspections David A. Pettenski, Supervisory Investigator U.S. Food & Drug Administration April 18, 2006 Determine if operations are in compliance with the laws and regulations
More informationMDSAP 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,
More informationVendor Qualification Survey
1200 West 96 th St Minneapolis, MN 55431 Ph: 952-888-7900 Fax: 952-888-2719 Vendor Qualification Survey Vendor Information Company Name: Date: Address: City: Phone Number: email address: Product or Service
More informationQuality Agreements and Managing Contract Supplier Quality
Quality Agreements and Managing Contract Supplier Quality American Society for Quality Lloyd Bailey November 3, 2005 Service Mark of The Dow Chemical Company TM Trademark of The Dow Chemical Company Abstract
More informationUPPLIER 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
More informationTechnical updates medicines inspections: Finished Pharmaceutical Products (FPP)
Technical updates medicines inspections: Finished Pharmaceutical Products (FPP) Vimal Sachdeva, Technical Officer (Inspector) WHO Prequalification Team (PQT), WHO/HIS/EMP/RHT 20 Avenue Appia, CH - 1211,
More information6/9/2016. Blytheco.com 1. Preparing For and Surviving FDA Inspections: Today s Agenda. Guidance for Nutraceutical Manufacturers
Presented by Beginning now Preparing For and Surviving FDA Inspections: Guidance for Nutraceutical Manufacturers Today s Agenda Introductions Discussion Q & A How to Participate Today Arrow = Open/close
More informationEFFECTIVE MANAGEMENT OF THE PROCESS VALIDATION LIFECYCLE VALIDATION MASTER PLAN DEVELOPMENT
EFFECTIVE MANAGEMENT OF THE PROCESS VALIDATION LIFECYCLE VALIDATION MASTER PLAN DEVELOPMENT Paul L. Pluta, PhD Journal of Validation Technology Journal of GXP Compliance University of Illinois at Chicago
More informationASTM D10-F02 Workshop FDA Regulatory Perspective. Patrick Weixel FDA Center for Devices and Radiological Health
ASTM D10-F02 Workshop FDA Regulatory Perspective Patrick Weixel FDA Center for Devices and Radiological Health 1 FDA Regulatory Perspective Focus of talk: Use of Standards Auditing Packaging Process Deficiencies
More informationStrategies for Risk Based Validation of Laboratory Systems
Strategies for Risk Based Validation of Laboratory Systems Video Web Seminar September 23, 2004 Ludwig Huber E-mail: ludwig_huber@agilent.com Today s Agenda Background information: why risk assessment,
More informationElectronic Records and Electronic Signatures (21 CFR Part 11)
Training Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003 Electronic Records and Electronic Signatures (21 CFR Part 11) Hans-Beat Jenny, SwissMedic, Basel
More informationUsing Capacity Building to Drive Continuous Improvement in Global Supply Chains
Using Capacity Building to Drive Continuous Improvement in Global Supply Chains Using Capacity Building to Drive Continuous Improvement in Global Supply Chains Corporate social responsibility (CSR) programs
More informationUL Pharmaceutical Good Manufacturing Practices (GMP) Procedure for Certification: RETAIL AND NATIONAL BRAND CERTIFICATION PROGRAMS (RCP, NBCP)
UL Pharmaceutical Good Manufacturing Practices (GMP) Procedure for Certification: RETAIL AND NATIONAL BRAND CERTIFICATION PROGRAMS (RCP, NBCP) About UL UL is a premier global independent safety science
More informationDocket No. FDA-2015-D-0198: Current Good Manufacturing Practice Requirements for Combination Products.
701 Pennsylvania Avenue, Ste. 800 Washington, DC 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org April 29, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630
More informationFSC36 SAFE FEED/SAFE FOOD GUIDANCE DOCUMENT
FSC36 SAFE FEED/SAFE FOOD GUIDANCE DOCUMENT FSC36 Safe Feed/Safe Food (www.safefeedsafefood.org) is a facility certification program for the American Feed Industry Association (www.afia.org) Version 7.0
More informationAn FDA Perspective on Atypical Active Ingredients
An FDA Perspective on Atypical Active Ingredients Presented by Steven Wolfgang, Ph.D. Center for Drug Evaluation and Research Office of Compliance Office of Drug Security, Integrity and Response steven.wolfgang@fda.hhs.gov
More informationQ10 PHARMACEUTICAL QUALITY SYSTEM
Q10 PHARMACEUTICAL QUALITY SYSTEM This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights
More informationFSMA Food Safety Seminar Japan External Trade Organization
FSMA Food Safety Seminar Japan External Trade Organization U.S. Food and Drug Administration s Risk-Based Preventive Controls for Human Food & Supply Chain Preventive Controls January 2017 Jolyda Swaim
More informationProcess validation in medical devices
Process validation in medical devices Fulfil requirements with expert regulatory guidance 1TÜV SÜD Contents INTRODUCTION 4 VALIDATION PLANNING 5 INSTALLATION QUALIFICATION 7 OPERATIONAL QUALIFICATION 9
More informationSupplier Quality Agreements
Supplier Quality Agreements Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 OMBU ENTERPRISES, LLC 1 Outline QSR Requirements
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 8 Inspections, Compliance, Enforcement, and Criminal Investigations Lupin Limited 5/7/09 Department of Health and Human Services Public Health Service Food and Drug Administration CENTER FOR
More informationDATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS
GLOBAL PROVIDER, LOCAL SOLUTIONS IN YOUR LANGUAGE DATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS Francesco Amorosi PhD Octorber 2017 DATA INTEGRITY & CSV:
More informationPART 820 QUALITY SYSTEM REGULATION. 21 CFR Ch. I ( Edition)
814.126 (b) Withdrawal of IRB approval. A holder of an approved HDE shall notify FDA of any withdrawal of approval for the use of a HUD by a reviewing IRB within 5 working days after being notified of
More informationImpacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
More informationISO 9001:2015. Quality Management System. Manual
ISO 9001:2015 Quality Management System Manual Introduction Company has made the Strategic Business Decision to develop and implement an effective Quality Management Systems (QMS) across all areas of the
More informationC.A.S.E. AIR CARRIER SECTION POLICIES AND PROCEDURES
C.A.S.E. 3-A STANDARD DISTRIBUTORS OF NEW AND SURPLUS PARTS QUALITY PROGRAM REQUIREMENTS Section Subject Page 1. Policy.... 2 2. Quality System and Quality Manual.... 3 3. Quality Organization..... 3 4.
More informationKathy Weil Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health US Food and Drug Administration
Kathy Weil Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health US Food and Drug Administration Kathy.Weil@fda.hhs.gov Follow the protocol and IDE regulations
More informationDrug and Device Makers Cited in 483s for CAPAs, Poor Documentation in 2014
Drug and Device Makers Cited in 483s for CAPAs, Poor Documentation in 2014 Copyright 2015 by FDAnews. All rights reserved. Photocopying or reproducing this report in any form, including electronic or facsimile
More informationUnderstanding GxP Regulations for Healthcare
Understanding GxP Regulations for Healthcare GxP Guidelines What is GxP? GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their
More informationEnabling Improvement through the Product Lifecycle: Change Management within a PQS
Enabling Improvement through the Product Lifecycle: Change Management within a PQS Denise DiGiulio, Senior Advisor OPQ Office of Process and Facilities PDA Chapter Meeting Melbourne, Australia April 3,
More information2015 > 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
More informationDarshit S. Patel, IJPSR, 2012; Vol. 3(12): ISSN: FDA WARNING LETTER ANALYSIS: A TOOL FOR GMP COMPLIANCE. Darshit S.
IJPSR (2012), Vol. 3, Issue 12 (Review Article) Received on 20 August, 2012; received in revised form 28 September, 2012; accepted 20 November, 2012 FDA WARNING LETTER ANALYSIS: A TOOL FOR GMP COMPLIANCE
More informationCombination Products: A 40 Year Regulatory Evolution
The right people. The right solution. The first time. Combination Products: A 40 Year Regulatory Evolution Technological advances in healthcare products and the delivery of those products will continue
More informationwww.ulehssustainability.com YOUR PARTNER IN EHS, SUSTAINABILITY AND SUCCESS UL EHS Sustainability is the leading environmental, health, safety and sustainability software provider for enterprise clients
More informationYOU RE CLOSER THAN YOU THINK
YOU RE CLOSER THAN YOU THINK ISO 13485:2016 READINESS CHECKLIST We understand that some of our customers would like to be able to check how close they are to meeting the requirements of ISO 13485:2016.
More informationFDA Drug Compliance. Pepe Rodriguez-Perez, PhD Business Excellence Consulting Inc / BEC Spain SL.
FDA Drug Compliance Presented by Pepe Rodriguez-Perez, PhD Business Excellence Consulting Inc / BEC Spain SL www.calidadpr.com email pepe@calidadpr.com Agenda 1. FDA s Strategic Priorities 2014-18 2. CDER
More informationGMP Requirements. Gabriel Kaddu, Senior GMP Specialist Promoting the Quality of Medicines Program (PQM) U.S. Pharmacopeial Convention (USP)
GMP Requirements Gabriel Kaddu, Senior GMP Specialist Promoting the Quality of Medicines Program (PQM) U.S. Pharmacopeial Convention (USP) 2016. ALL RIGHTS RESERVED. Outline GMP Procedures and standards
More informationCSV Inspection Readiness through Effective Document Control. Eileen Cortes April 27, 2017
CSV Inspection Readiness through Effective Document Control Eileen Cortes April 27, 2017 Agenda Background CSV Readiness CSV and Change Management Process Inspection Readiness Do s and Don ts Inspection
More informationSUPPLIER AUDITS AND FSMA CERTIFICATION. Hank Karayan, SGS Global FSMA Program Director May 24, 2018
SUPPLIER AUDITS AND FSMA CERTIFICATION Hank Karayan, SGS Global FSMA Program Director May 24, 2018 1 FSMA RULES & THEIR APPLICABILITY 7 Rules of FSMA Manufacture, Processing, Dist n Centers & Warehouses
More information9 th Annual Inspections Summit Oct , 2014 Bethesda, MD
9 th Annual Inspections Summit Oct. 22-24, 2014 Bethesda, MD Pre-Conference Agenda 12:00 p.m. 1:00 p.m. Registration 1:00 p.m. 5:00 p.m. Flawless FDA Inspection Handling and Response We found your response
More informationMEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 EXECUTIVE SUMMARY Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part
More informationPAT & Risk-Based Initiatives: Implementation Issues PDA New England - 8 th Dec Cliff Campbell B.E., C.Eng. CC&A Ltd., Cork, Ireland
PAT & Risk-Based Initiatives: Implementation Issues PDA New England - 8 th Dec 2004 Cliff Campbell B.E., C.Eng. CC&A Ltd., Cork, Ireland cca@iol.ie 1 FDA Context 1) FDA 5-Part Strategic Plan Protect &
More informationQuality Manual ISO 9001:2000
Quality Manual ISO 9001:2000 Page 2 of 23 TABLE OF CONTENTS COVER PAGE...1 TABLE OF CONTENTS...2 SIGNATURES...3 QUALITY POLICY...4 INTRODUCTION...5 CORPORATE PROFILE...9 4.O QUALITY MANAGEMENT SYSTEM...10
More informationZOLL Document Number: 90E0021 Page 6 of 50 QUALITY SYSTEM MANUAL ZOLL Document Number: 90E0021 Page 7 of 50 1 EXECUTIVE MANAGEMENT APPROVAL... 10 2 INTRODUCTION... 11 3 QUALITY SYSTEM... 12 3.1 QUALITY
More informationOvercome the Top Challenges of Handling OOS Results by Knowing FDA Observations
Overcome the Top Challenges of Handling OOS Results by Knowing FDA Observations Jerry Lanese Ph.D. The Lanese Group, Inc. 2015 The Lanese Group, Inc. 1 Who decided you should come to this conference? On
More informationOsprey Technologies, LLC. Quality Manual ISO9001:2008 Rev -
February 8, 2015 1 Osprey Technologies, LLC Quality Manual ISO9001:2008 Rev - February 8, 2015 Released by Dave Crockett President 6100 S. Maple Avenue, Suite 117 Tempe, AZ 85283 www.osprey-tech.com February
More informationAnnex 4. Guidance on good manufacturing practices: inspection report. Background
Annex 4 Guidance on good manufacturing practices: inspection report Background The need for revision of the Guidance on good manufacturing practices: inspection report (World Health Organization (WHO)
More informationFSMA Information & Compliance for Fuel Ethanol Producers
FSMA Information & Compliance for Fuel Ethanol Producers Compli Associates 605.254.1077 compli@compliassociates.com www.compliassociates.com About Compli Associates Compli Associates specializes in developing
More informationINTERNATIONAL ASSOCIATION OF PLUMBING AND MECHANICAL OFFICIALS UNIFORM EVALUATION SERVICES
INTERNATIONAL ASSOCIATION OF PLUMBING AND MECHANICAL OFFICIALS UNIFORM EVALUATION SERVICES EVALUATION CRITERIA FOR STRUCTURAL STEEL APPROVED FABRICATOR INSPECTION PROGRAMS 1.0 PURPOSE EC 020-2014 (Adopted
More informationQuality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:
NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a
More informationOn-Site GMP Training GMP COMPLIANCE TECHNICAL
PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program
More informationGeneral Requirements for the Competence of Testing and Calibration Laboratories
ISO 17025:2005 POSITION PAPER General Requirements for the Competence of Testing and Calibration Laboratories EXECUTIVE SUMMARY This position paper provides a high-level overview of how LabVantage supports
More informationSupplement FSSC & FSMA for Human Food FOOD SAFETY SYSTEM CERTIFICATION Supplement FSSC & FSMA for Human Food
Supplement FSSC & FSMA for Human Food FOOD SAFETY SYSTEM CERTIFICATION 22000 Supplement FSSC 22000 & FSMA for Human Food Version 1.0: September 2017 Supplement FSSC 22000 & FSMA for Human Food Contents
More informationRegulatory Overview Annex 11 and Part 11. Sion Wyn Conformity +[44] (0)
Regulatory Overview Annex 11 and Part 11 Sion Wyn Conformity +[44] (0) 1492 642622 sion.wyn@conform-it.com 1 Two Key Regulations Annex 11 21 CFR Part 11 Apply to the regulated company, but often have a
More informationNavigating an FDA GMP and Validation Inspection- Best Practices and Pitfalls
Navigating an FDA GMP and Validation Inspection- Best Practices and Pitfalls Sonali P. Gunawardhana FDA Practice Group Wiley Rein LLP 1776 K Street NW Washington, DC (202) 719-7454 sgunawardhana@wileyrein.com
More information