TSCA Compliance Best Practices
|
|
- Dorthy Norton
- 6 years ago
- Views:
Transcription
1 TSCA Compliance Best Practices Bonita G. Reynolds November 20, 2017
2 Objectives 1. SHARE proven best practices 2. MAKE the case for establishing and maintaining a TSCA Compliance program 3. PROVIDE an outline for a TSCA Compliance Manual and other documentation
3 In general: 1. Stay informed, well connected, and compliant 2. Create a compliance culture 3. Document your program 4. Count the costs 5. Self assess/audit routinely 6. Do not delay 7. Manage change
4 TSCA Compliance Program Make it a way of life!
5 The Program: 1. Company compliance policies 2. Guiding principles 3. Trained, engaged/empowered personnel 4. Comprehensive/communicated plans 5. Protected products 6. SMART protocols, processes, procedures 7. Reliable platforms 8. Relevant Perspectives 9. Timely preparation 10. Managed pain points
6 Intelligent Compliance: 1. Be savvy about the law and its impact on your business define and maintain your TSCA profile 2. Seek and secure buy-in company wide from Cleaner to CEO 3. Make TSCA Compliance a budget line item, or more 1. Human, literature, training, travel 2. Compliance efforts including feed 4. Maintain a robust TSCA Compliance program 1. Written 2. Audit ready 3. Covering activities from dock to dump, shower to Wall St. 4. Mirroring the Statute focusing on which parts are applicable
7 Sustainable Progress: 1. TSCA is the premier chemical management law in the USA difficult to escape, bad business to ignore. 2. TSCA Compliance impacts the health and wealth of your business. 3. TSCA compliance, while complex, is completely doable. 4. Non-compliance is costly fines, bans/restrictions, damage to your brand, other 5. TSCA Compliance, when effective, is a value proposition
8 A safer world: Made so by policies : Corporate commitment Include statement of purpose, quality goals, due diligence, responsible care Departmental goals S.M.A.R.T. Complete with roles and responsibilities Personal responsibility Each stakeholder to acknowledge his/her own part to play and principles: 1. That compliance is good business, it is a value proposition 2. That compliance is part of the fabric of our lives 3. That ignorance is no excuse, and knowledge is power
9 People trained and authorized: Upper Management Coordinators Specialists CDX Submitter roles: AO, TC Consultants Contractors Others: Purchasing, Production, Customer Service, R&D, Salespersons, Shipping and Receiving Every employee
10 Proactive plans: Know your compliance burdens and allowances Ensure the persons with relevant expertise are assigned to tasks and functions Keep processes simple, but documented Ensure procedures are complete, current and communicated Compile and maintain your own Inventory Protect your CBI, designate sanitization conventions Keep in touch with EPA, Industry, legal team, Consultants, Suppliers, trade brokers, Customers
11 Products: identify them by chemistry and function/use Raw Materials = components/ingredients/base chemicals Intermediates Finished Products Naturally occurring Pure vs. Mixtures vs. reacted products Polymers Articles R&D Reagents/processing aids Impurities and by-products
12 Your own Inventory: Categorize by how regulated by TSCA and status! Listed, active, inactive Exempt Regulated - 4, 5, 6, 8, 12, 13, SNUR, hi/lo priority CDR reportable Manufactured, imported, tolled, processed, distributed, how disposed Keep current on a retrievable spreadsheet, or database Maintain a catalog of supporting documentation: 8b Searches, CAS RN results, certifications, notifications, tests, studies, P2 Modeling, PNCs, letters to and from EPA, supplier questionnaires, Self Assessment / Audit Findings, training Submissions to EPA SDS and Labels CBI Federal Register notices
13 Preparation/platform: Maintain a posture of preparedness people, products, records, site Ensure records are retrievable Practice for audit readiness Designate a host/ spokesperson Self disclose if necessary, under strict protocol Host a reliable platform- Simple to complex Training formal and on the job EPA CDX presence roles and IDs
14 Perspectives: 1. Owners, Executive Board, Shareholders 2. Functional importer/manufacturer; processor; 3. Supporting R&D, Production, Purchasing, Marketing, Waste Management 4. Knowledge Managers 5. Advocates and Consultants 6. Analysts 7. Those who prepare submissions 8. Every stakeholder 9. Customers and downstream users 10. Competitors
15 Management of Change Products formulations, uses, sites, where distributed, how notified Processes internal and external especially any submitted and binding adhere to record keeping/retention schedules Documents current and consistent Persons responsible in supply/value chain purchasing to disposal People trained in the workflow Statutory rules and requirements
16 TSCA Compliance Manual Write it down!
17 The Manual: 1. Title page 2. Dates and Signatures of Preparers 3. Table of contents 4. Policy statements corporate, purpose 5. Applicable sections of the statute 6. Definitions and 40 CFR references 7. Your Inventory and TSCA Status 8. Training, Roles and Responsibilities, functions and tasks 9. Affiliations and contacts 10. SOPs 11. Calendar 12. Documents templates and examples 13. Attachments and links to supporting documentation
18 Other looks for a Manual: Who, what, which, whom, when, why, how, how many, how not, where The Regulation, its rules, its requirements, relevant parts, references, roles and responsibilities, records, Reform Make the Manual a part of your Product Stewardship Portfolio
19 Practical considerations: Do you have a written program? Has it been tested or audited? How often do you review and update? Have you updated for CDR, TSCA Reform? What are funds needed for this endeavor? What are the risks involved? What misconceptions do you harbor about TSCA Compliance?
20 Q A Thank You!
Toxic Substance Control Act Reform and Chemical Data Reporting Requirements: A Roadmap for TSCA CDR Compliance
Toxic Substance Control Act Reform and Chemical Data Reporting Requirements: A Roadmap for TSCA CDR Compliance Table of Contents 1. Executive Summary 2. Introduction 3. Regulations and Responsibilities
More informationSupply Chain Management for Composite Wood Products
Supply Chain Management for Composite Wood Products AHFA January 2017 Brian Kniebel & Dr. Pratik Ichhaporia January 18, 2017 Agenda 01 02 03 Overview Supply Chain Requirements Risk Mitigation & Implementation
More informationEnterprise Compliance Management for Credit Unions
Enterprise Compliance for Credit Unions Streamline Regulatory Compliance with a Unified Platform to Manage Requirements and Demonstrate Compliance to Regulators Industry Challenge Credit unions are subject
More informationDHL THERMONET SETTING NEW STANDARDS IN TEMPERATURE CONTROLLED SHIPPING
DHL THERMONET SETTING NEW STANDARDS IN TEMPERATURE CONTROLLED SHIPPING YOUR COLD CHAIN SOLUTION TO COVER THE WORLD Transporting temperature controlled shipments for the Life Sciences and Healthcare industry
More informationOPW Engineered Systems
1 of 5 1.0 Purpose 1.1 The purpose of this manual is to promote a clear understanding of OPW Engineered Systems (OPW-ES) expectations and requirements for suppliers. This manual explains the process OPW-
More informationToxic Substance Control Act for Laboratories: Compliance Essentials to Avoid Costly Penalties
Toxic Substance Control Act for Laboratories: Compliance Essentials to Avoid Costly Penalties Presented by: Stan Abramson Arent Fox Anne Sefried BIOVIA Sponsored By: Thursday, November 11, 2014 2:00 p.m.
More informationCHEMICAL COMPLIANCE THEWERCS.COM 1
CHEMICAL COMPLIANCE THE.COM 1 FACTS AND FIGURES Nearly 22 billion UL Marks appeared on products 69,795 Customers worldwide 152 Number of facilities in the UL family of companies 106 Countries with UL customers
More informationJanuary 17, Attention: Docket Number EPA-HQ-OPPT
Document Control Office (7407M) Office of Pollution Prevention and Toxics 1200 Pennsylvania Avenue N.W. Washington, DC 20460-0001 Attention: Docket Number EPA-HQ-OPPT-2016-0658 Re: Comments of the Color
More informationT S C A INVENTORY NOTIFICATION ACTIVE-INACTIVE REQUIREMENTS
T S C A INVENTORY NOTIFICATION ACTIVE-INACTIVE REQUIREMENTS NOTIFICATION DEADLINE WHAT IS TSCA Manufacturer / Importer Reporting Deadline Processor Reporting Deadline February 7, 2018 October 5, 2018 RISKS
More informationInfor EAM for Life Sciences
Infor EAM Infor EAM for Life Sciences Protect your bottom line The stringent regulations imposed on life sciences companies are in place for a good reason to reduce the health, safety, and security risks
More information#12 1 / DoD Chief FOIA Officer Report COMPLETE. PAGE 1: Please use the online tool to submit your 2017 Chief FOIA Officer Report.
#12 COMPLETE Collector: Email Invitation 1 (Email) Started: Monday November 14 2016 10:49:00 AM Last Modified: Friday November 18 2016 2:19:28 PM Time Spent: Over a day Email: yashmina.reed@dodiis.mil
More informationEVALUATING CONTRACT LIFECYCLE MANAGEMENT SOLUTIONS: BEST-IN-CLASS FEATURES
EVALUATING CONTRACT LIFECYCLE MANAGEMENT SOLUTIONS: BEST-IN-CLASS FEATURES INTRODUCTION INTRODUCTION CONTRACTS FORM THE FOUNDATION OF ALL BUSINESSES AND EVERY BUSINESS RELATIONSHIP. THEY DEFINE EVERY ASPECT
More informationThe Regulation of Renewable Chemicals under the Toxic Substances Control Act (TSCA)
1 The Regulation of Renewable Chemicals under the Toxic Substances Control Act (TSCA) By Lynn L. Bergeson Biobased Chemicals a Fast-Growing Sector are Subject to TSCA The United States government is committed
More informationProduct Compliance for Discrete Manufacturers
SAP Brief SAP s for Sustainability Product Safety and Stewardship s from SAP Objectives Product Compliance for Discrete Manufacturers Protect marketability and automate product compliance Protect marketability
More informationCorporate Overview. Intelligent compliance. Sustainable progress. A safer world. 1
Corporate Overview Intelligent compliance. Sustainable progress. A safer world. 1 Intelligent compliance. Sustainable progress. A safer world. Regulatory requirements that directly impact business activities
More informationTHE TOXIC SUBSTANCES CONTROL ACT FREQUENTLY ASKED QUESTIONS. 1. What is a chemical substance for purposes of regulation under TSCA?
1203 Nineteenth Street, NW Suite 300 Washington, DC 20036-2401 tel 202.557.3800 fax 202.557.3836 web www.lawbc.com THE TOXIC SUBSTANCES CONTROL ACT FREQUENTLY ASKED QUESTIONS 1. What is a chemical substance
More informationWestern Diversified Plastics, LLC. Supplier Requirements Manual
Western Diversified Plastics, LLC. Supplier Requirements Manual Revision Date: 12/10/2019 TABLE OF CONTENTS 1.0 Introduction.. 3 2.0 WDP Supplier Policy.. 4 3.0 Scope... 4 4.0 Launch Readiness Measures...
More informationEPA s Formaldehyde Rule: Importer Best Practices
EPA s Formaldehyde Rule: Importer Best Practices International Wood Products Association Mark N. Duvall April 7, 2017 Overview Reasonable precautions Labeling Import certification Non-complying lots 2
More informationEnhanced calibration High quality services from your global instrumentation partner
Products Solutions Services Enhanced calibration High quality services from your global instrumentation partner Services 2 Calibration One trusted advisor Get the best to meet all your critical application
More informationTitle: ISO 9001 Quality Manual Doc. No: CAP-1004 Page 1 of 22
Doc. No: CAP-1004 Page 1 of 22 Doc. No: CAP-1004 Page 2 of 22 Table of Contents 1. ABOUT THE ORGANIZATION... 4 1.1. ORGANIZATIONAL STRUCTURE... 4 2. PURPOSE, SCOPE AND USERS... 5 3. TERMS AND DEFINITIONS...
More informationUSE OF REMOTE RODENT MONITORING WITH REGARD TO FOOD SAFETY REGULATIONS AND CURRENT PEST CONTROL PRACTICES
V 2.0 USE OF REMOTE RODENT MONITORING WITH REGARD TO FOOD SAFETY REGULATIONS AND CURRENT PEST CONTROL PRACTICES 2019 BAYER CROPSCIENCE LP TABLE OF CONTENTS 01 SUMMARY 1. SUMMARY 3 2. INTRODUCTION 4 3.
More informationSOLUTION BRIEF DOSSIER MANAGEMENT
SOLUTION BRIEF DOSSIER MANAGEMENT BUSINESS CHALLENGES The end-to-end submission management process is very complex, supporting many cross-functional processes such as manufacturing, R&D document authoring
More informationbluesign system Version 1.0 April 01, 2014
bluesign system Version 1.0 April 01, 201 Content 1 Introduction 2 Scope Definitions.1.2...5.6.7.8.9.10.11 BAT bluesign system bluesign system partner bluesign applications bluesign system substances list
More informationPCI FOR HIGHER EDUCATION. John Musgrove, MS, CISA Deputy Director, Technology Audit
PCI FOR HIGHER EDUCATION John Musgrove, MS, CISA Deputy Director, Technology Audit Mandate Everyone involved in the payment process has a duty to consumers to protect their data to the highest standard.
More informationAN ENTIRELY NEW PROCESS- AND EXECUTION- CENTRIC APPROACH TO LIMS IMPLEMENTATIONS
DATASHEET ACCELRYS LIMS AN ENTIRELY NEW PROCESS- AND EXECUTION- CENTRIC APPROACH TO LIMS IMPLEMENTATIONS Accelrys LIMS is purpose-built to manage 21st-century product and process informatics requirements
More informationEPA Assessing Utility of Toxic Substances Control Act to Obtain Information on Hydraulic Fracturing Chemical Substances and Mixtures
EPA Assessing Utility of Toxic Substances Control Act to Obtain Information on Hydraulic Fracturing Chemical Substances and Mixtures By Lynn L. Bergeson The United States Environmental Protection Agency
More informationSimplifying Clinical Trials
Simplifying Clinical Trials A division of Phoenix Progressive Certifications Enterprise Pvt. Ltd. A division of Phoenix Progressive Certifications Enterprise Pvt. Ltd. Company Overview : PPCE is an efficient
More informationAs discussed in Chapter 5, 21 CFR introduces the concept of and basic requirements for preventive controls. Recall that a preventive control
(The supply chain program described in this chapter is not the same as a supply chain program typically thought of by the animal food industry. In fact, supplychain applied controls may have limited applicability
More informationCharles River Software as a Service (SaaS)
Charles River Software as a Service (SaaS) A Managed Solution that Supports Critical Business Needs Charles River deploys its investment management solution as a cloudbased service to help firms simplify
More informationConfiguring E-Procurement to Achieve Early Wins
Configuring E-Procurement to Achieve Early Wins The automation of business processes enables procurement departments to go beyond savings in creating business value for stakeholders. Failure to do so negatively
More information4. RELATED DOCUMENTS AND FORMS 4.1. AS ISO Cambridge Valley Machining, Inc. QMS procedures, including, but not limited to:
Approved By: Purchasing Manager Candice Lane (signature on file) Date: 5/26/17 Approved By: Process Owner James D. Moore (signature on file) Date: 5/26/17 1. PURPOSE 1.1. To define Cambridge Valley Machining,
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 informationJOB DESCRIPTION: FACILITIES MANAGER. The Principal via the Senior Assistant Principal (Finance & Resources)
JOB DESCRIPTION: FACILITIES MANAGER Post Title: Responsible to: Purpose: Liaising with: Context: Facilities Manager The Principal via the Senior Assistant Principal (Finance & Resources) To lead the estates
More informationA High-Touch Approach to Improving Patient Access. Using field support to navigate reimbursement challenges
A High-Touch Approach to Improving Patient Access Using field support to navigate reimbursement challenges For the brand and reimbursement teams who must develop commercial strategies for the biopharmaceutical
More informationThomson Reuters Regulatory Change Management
Thomson Reuters Regulatory Change Management TRACK AND MANAGE THE IMPACT OF REGULATORY CHANGE 2 Thomson Reuters Regulatory Change Management provides your organization with enhanced mapping capabilities
More informationLast Updated November 7, Hanna Gustafson. TSCA Training Tier I Modula A
Hanna Gustafson 1 Background Introduction Challenge Solution Result 2 SAP ERP EHS module is common EHS module is base for other extensions SAP software extensions 3 rd Parties Verisk 3E s 3E Insight for
More informationWhile the recognition
Designing the Perfect Change Control System Change control systems today are expected to be designed in a way that provides a system to not only document and approve changes, but also to anticipate change
More informationFinding a safe harbor within the IT storm
Finding a safe harbor within the IT storm Managing the delivery of IT services is a turbulent process. The unified capabilities of Dell and BMC Software can help you find a safe harbor within the IT storm.
More informationGeneral Data Privacy Regulation: It s Coming Are You Ready?
General Data Privacy Regulation: It s Coming Are You Ready? Presenters Tristan North Worldwide ERC Government Affairs Adviser, Moderator William R. Tehan General Counsel, Graebel Companies, Inc. Hank A.
More informationPOLICIES. 1.3 Certification Criteria In order for a company to be eligible for FIRST Company Certification, the following criteria must be met:
POLICIES Section 1: ABOUT FIRST COMPANY CERTIFICATION The Flexographic Technical Association (FTA) is the body responsible for the FIRST Company Certification Program. FTA will grant certification to companies
More informationPROPOSAL OUTLINE PRIVACY IMPACT ASSESSMENT
PROPOSAL OUTLINE PRIVACY IMPACT ASSESSMENT 1. Introduction A great deal of confusion surrounds the application of the Personal Information and Electronic Documents Act (PIPEDA) and the various provincial
More information~_Awl (99' ~.,..,~., ~.. FEDERAL EXPRES S. Cahill, Dear Mr.
~_Awl (99' ~.,..,~., ~.. ~J+ DEPARTMENI.OF HEALTH & HUMAN SERVICES Public Health Serv ice FEDERAL EXPRES S WARNING LETTER Food and Drug Administratio n Center for Devices and 1 ~ ~yy Radiological ~ Health
More information11.0 FDA-Regulated Research
11.0 FDA-Regulated Research The HSC evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationSafe Supply Chains Help Produce Sustainable Businesses
Safe Supply Chains Help Produce Sustainable Businesses While international supply chains have created tremendous business opportunities for companies, they have spurred great risks, too. It is no longer
More informationOFFICE OF INSPECTOR GENERAL PALM BEACH COUNTY AUDIT REPORT: 2012-A-0004 CHILDREN S SERVICES COUNCIL REPORT ON EXTERNAL QUALITY REVIEW
PALM BEACH COUNTY AUDIT REPORT: 2012-A-0004 CHILDREN S SERVICES COUNCIL REPORT ON EXTERNAL QUALITY REVIEW Sheryl G. Steckler Inspector General Enhancing Public Trust in Government SUMMARY RESULTS AT A
More informationAccuratus Lab Services Quality Manual. Revision 003. Index
This quality policy manual is for the use of, its clients, vendors and the appropriate regulatory agencies. Unauthrized duplication or transfer to others is prohibited. Index Authorization... 3 Introduction...
More informationWORKING WITH THIRD PARTIES POLICY POLICY ADOPTED MARCH 2015, REVISED FEBRUARY 2017
WORKING WITH THIRD PARTIES POLICY POLICY ADOPTED MARCH 2015, REVISED FEBRUARY 2017 TABLE OF CONTENTS WORKING WITH THIRD PARTIES POLICY... 3 Introduction... 3 Working with third parties... 3 Due diligence
More informationProduct Stewardship: Impact on Brand, Compliance, and Risk Management
Product Stewardship: Impact on Brand, Compliance, and Risk Management John Phillips Technical Director Product Stewardship, North America December 2016 www.erm.com The business of sustainability Product
More informationThe New Old TSCA. Imogene Treble, PhD Elaine Freeman, MS DABT E x ponent, Inc.
The New Old TSCA Imogene Treble, PhD Elaine Freeman, MS DABT E x ponent, Inc. The New Old TSCA TSCA Overview TSCA New Chemicals TSCA Chemical Data Report TSCA Existing Chemicals TSCA Reform 2 TSCA Overview
More informationIntroducing a hosted CRM system designed exclusively for telecoms, fixed-line & IT resellers. ordering
thelayer.com thelayer.com Introducing a hosted CRM system designed exclusively for telecoms, fixed-line & IT resellers Platform Introduction The Layer takes advantage of everything that is unique about
More informationOutsource or in-house? The evolving role of analytical services in pharmaceutical manufacturing
Outsource or in-house? The evolving role of analytical services in pharmaceutical manufacturing By Impact Analytical Introduction About Impact Analytical Impact Analytical is a contract analytical testing
More informationSTATE OF OHIO DEPARTMENT OF TRANSPORTATION SUPPLEMENT 1069 PRE-QUALIFIED AGGREGATE SUPPLIER PROGRAM. April 18, 2008
STATE OF OHIO DEPARTMENT OF TRANSPORTATION SUPPLEMENT 1069 PRE-QUALIFIED AGGREGATE SUPPLIER PROGRAM April 18, 2008 1069.01 Description 1069.02 Definitions 1069.03 General Pre-qualification Requirements
More informationPlanning for and Managing FDA Inspections. Focus: 21 CFR, Part 820
Planning for and Managing FDA Inspections Focus: 21 CFR, Part 820 Information, Preventive Action and Strategy 1 The Authority behind Inspections The Safe Medical Devices Act of 1990 (the SMDA), enacted
More informationPURCHASING QUALITY CLAUSES
Page 1 of 5 These requirements apply to all suppliers A. Right of Entry Tri Models, Tri Model s customer and their customers or applicable regulatory agencies shall have right of access to all facilities,
More informationSupplier Quality Manual
Supplier Quality Manual Approvals: Quality Manager: Patrick Eckrich Date: 08/18/2017 Materials Manager: Dennis Okocha Date: 08/18/2017 Supplier Quality Manual Rev. _E_, Dated _August 18, 2017 Page 1 of
More informationTualatin Valley Water District
We are a Sustainably Oriented, SHARP Safety Graduate and an Equal Opportunity Employer Tualatin Valley Water District Full-Time Job Opening: Business Analyst Salary Grade 7: start $31.70 to midpoint $39.63
More information11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics
11.0 FDA-Regulated Research The IRB evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More information*** DRAFT - NOT YET FILED ***
*** DRAFT - NOT YET FILED *** 3745-36-10 Alternative conditions specific to categorical industrial users. [Comment: For dates of non-regulatory government publications, publications of recognized organizations
More informationDHL INTERNATIONAL SUPPLY CHAIN DISCOVER THE ADVANTAGE OF A SMARTER SUPPLY CHAIN
DHL INTERNATIONAL SUPPLY CHAIN DISCOVER THE ADVANTAGE OF A SMARTER SUPPLY CHAIN DHL Global Forwarding Excellence. Simply delivered. ARE YOU READY TO GROW YOUR BUSINESS? The international trade landscape
More informationThe EU REACH Regulation
The EU REACH Regulation CMS Supply Chain Innovation Workshop WSP Environmental Strategies October 25, 2007 Agenda Introduction How Will REACH Impact Industry? Key Elements and Timetable Potential Consequences
More informationThe way to optimize business conditions
The way to optimize business conditions DEKRA Business Assurance Services Assuring standards, ensuring business ... Why Mr. Lothar Weihofen Managing Director DEKRA Certification ... Running a business
More informationSIMPLIFIES AND STREAMLINES THE CLAIMS SUBMISSION, MONITORING AND RESOLUTION PROCESS
SIMPLIFIES AND STREAMLINES THE CLAIMS SUBMISSION, MONITORING AND RESOLUTION PROCESS A Jardine Matheson Associate Company what is? JLT Interactive s 3rd generation online claims management product helps
More informationA COMPLIANCE SOLUTION DESIGNED TO HELP PLANS MEET CMS REQUIREMENTS
A COMPLIANCE SOLUTION DESIGNED TO HELP PLANS MEET CMS REQUIREMENTS Founded on the Common Conditions, Improvement Strategies, and Best Practices based on 2013 Program Audit Reviews HPMS memo, dated August
More informationBrilliant Manufacturing from GE Digital: The Manufacturing Software for Hybrid Industries
Brilliant Manufacturing from GE Digital: The Manufacturing Software for Hybrid Industries Increase productivity, ensure quality, and reduce costs The Industrial Internet of Things (IIoT) is bringing about
More informationHealth Authority Inspection Management. GMP Inspection practices L. Mansolelli, Group Compliance & Auditing June 2012
Health Authority Inspection Management GMP Inspection practices L. Mansolelli, Group Compliance & Auditing June 2012 Abstract As global health authorities align in inspection standards and practices, key
More informationThe Future Moves Fast: Are You Ready to Respond?
The Future Moves Fast: Are You Ready to Respond? Embracing change with confidence: the future of indirect tax Disruption is here. Are you on the right side? In an age of nonstop innovation, simplicity
More informationTURBO MACH A DIVISION OF VT SAA
TERMS AND CONDITIONS PAGE: 1 OF 5 1. PURPOSE To define specific terms and conditions for the purchase of product, materials and services. 2. SCOPE All products, materials and services purchased for use
More informationPRINCIPLES OF KING IV AND DISCLOSURE REQUIREMENTS
Principles of King IV and disclosure requirements This report is to be read in conjunction with the remaining provisions of Gemgrow s 2017 integrated annual report in particular the corporate governance
More informationImplementation & Documentation Requirements for ISO 22716:2007 Certification
Implementation & Documentation Requirements for ISO 22716:2007 Certification ISO 22716 is an international standard that gives guidance for the production, control, storage and shipment of cosmetic products.
More informationJOB DESCRIPTION: FACILITIES MANAGER. The Principal via the Director of Finance, Resources & Estates
JOB DESCRIPTION: FACILITIES MANAGER Post Title: Responsible to: Purpose: Liaising with: Context: Facilities Manager The Principal via the Director of Finance, Resources & Estates To lead the estates and
More informationConnecticut s Dam Safety Program Safer Dams Initiative & House Bill 6441 Art Christian, P.E.
Connecticut s Dam Safety Program Safer Dams Initiative & House Bill 6441 Art Christian, P.E. Supervising Civil Engineer CT DEEP Office of Dam Safety Connecticut Department of Energy and Environmental Protection
More informationU. S. Department of Energy. Consolidated Audit Program Treatment, Storage and Disposal Facilities. Checklist 1 Quality Assurance Management Systems
U. S. Department of Energy Consolidated Audit Program Treatment, Storage and Disposal Facilities Checklist 1 Quality Assurance Management Systems Revision 1.3 December 2013 Audit ID: Date: Quality Assurance
More informationQuality Manual. Index
This quality policy manual is for the use of, its Clients, Vendors, and the appropriate Regulatory Agencies. Unauthorized duplication or transfer to others is prohibited. Index Authorization... 3 Introduction...
More informationSQF 2000 Code. 6th Edition AUGUST A HACCP-Based Supplier Assurance Code for the Food Manufacturing and Distributing Industries
SQF 2000 Code A HACCP-Based Supplier Assurance Code for the Food Manufacturing and Distributing Industries 6th Edition AUGUST 2008 Safe Quality Food Institute 2345 Crystal Drive, Suite 800 Arlington, VA
More information11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics
11.0 FDA-Regulated Research The IRB evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationGMPs: Distribution Centers
SkillsPlus International Inc. The On-Site Series GMPs: Distribution Centers Learn to apply the GMP regulations as they relate to distribution center operations! FDA Past, Present, and Future and opener
More informationCUSTOMER AND SUPPLIER ROLES AND RESPONSIBILITIES FOR 21 CFR 11 COMPLIANCE ASSESSMENT. 21 CFR Part 11 FAQ. (Frequently Asked Questions)
21 CFR Part 11 FAQ (Frequently Asked Questions) Customer and Supplier Roles and Responsibilities for Assessment of METTLER TOLEDO STARe Software Version 16.00, including: - 21 CFR 11 Compliance software
More informationGDPR SMART. The Neopost Guide to Managing GDPR. ermissions Personal Data Right of Access. nal Data Right of Access Consent Permissi
s Personal Data Right of Access l Data Right of Access Consent P f Access Consent Permissions Pe sent Permissions Personal Data Rig ions Personal Data Right of Access nal Data Right of Access Consent P
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 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 informationApproved Supplier Guidance
Approved Supplier Guidance Administrative Office: 2420 W. R. Larson Rd. San Antonio, Texas 78261 (210) 384-3484 FAX (830) 438-2309 D&D Machinery and Sales Inc. Approval by: Original copy retained in D&D
More information2012 Brazilian Electronic Test and Measurement Customer Service Leadership Award
2012 2012 Brazilian Electronic Test and Measurement Customer Service Leadership Award 2012 Frost & Sullivan 1 We Accelerate Growth Customer Service Leadership Award Electronics Test and Measurement Brazil,
More informationEnterprise Risk Management: Ways to Prepare for and What to Do During a Recall
Enterprise Risk Management: Ways to Prepare for and What to Do During a Recall The creation and implementation of an enterprise risk management ( ERM ) plan at your company is integral to minimizing and
More informationISD SENIOR MANAGER STRATEGY AND ARCHITECTURE. Purpose. More information
ISD SENIOR MANAGER STRATEGY AND ARCHITECTURE Information Technology (IT) and end-to-end communication systems are a critical enabler to HPUK s successful business operations. The Information Systems Department
More informationIntroduction to Toxic Release Inventory Reporting. A&WMA Iowa Chapter May 2014
Introduction to Toxic Release Inventory Reporting A&WMA Iowa Chapter May 2014 Agenda Introduction to TRI Reporting Applicability Determinations Activity Threshold Determinations Manufacture, Process, Otherwise
More informationIoD Code of Practice for Directors
The Four Pillars of Governance Best Practice Institute of Directors in New Zealand (Inc). IoD Code of Practice for Directors This Code provides guidance to directors to assist them in carrying out their
More informationAuditing Your Global GHS Program
Auditing Your Global GHS Program Employee health and product safety, stewardship, and compliance Medical Department Toxicology & Compliance Solutions Occupational Medicine & Health Physics EHS Information
More informationXerox LiveKey and Xerox Transactional Content Manager (XTCM) Technology and Innovation White Paper
Xerox LiveKey and Xerox Transactional Content Manager (XTCM) Technology and Innovation White Paper 1 Executive Summary For hundreds of years, business has been driven by paper. From letters to forms, from
More informationQUALITY AGREEMENT. The following Agreement has been concluded between
QUALITY AGREEMENT The following Agreement has been concluded between LLC LABORATORIES The contract laboratory and service provider 1625 Trinity Dr., Unit 11 Mississauga, Ontario Canada L5T 1W9 Hereinafter
More informationQUALITY ASSURANCE. Pharma Quality Agreements: What Are They, and Why They Matter For Your Study ABSTRACT
WHITE PAPER PRESENTED BY PREMIER RESEARCH Pharma Quality Agreements: What Are They, and Why They Matter For Your Study ABSTRACT Quality Agreements are an effective bridge to a successful future for companies
More informationNew Hazardous Waste Rules
New Hazardous Waste Rules Changes and How They Affect Arizona David R. Janke Environmental Scientist II Rule Changes Reporting Changes How ADEQ is Affected New Hazardous Waste Rules Introduction Signed
More informationAre you our new EU Funding Manager?
Are you our new EU Funding Manager? The basics Location: Reporting to: Salary: Working Hours: Holidays: Contract: Equal Opportunities: Central London (with some travel including Brussels) Head of CR&D
More informationThe Smart ERP Choice for the Metals Industry
Crowe Metals Accelerator for Microsoft Dynamics 365 for Operations Software The Smart ERP Choice for the Metals Industry Audit / Tax / Advisory / Risk / Performance Smart decisions. Lasting value. Fully
More informationUNIFIED FACILITIES GUIDE SPECIFICATIONS ************************************************************************** SECTION TABLE OF CONTENTS
USACE / NAVFAC / AFCEC / NASA UFGS-01 45 00.00 40 (November 2017) ----------------------------------- Preparing Activity: NASA Superseding UFGS-01 45 00.00 40 (November 2014) UNIFIED FACILITIES GUIDE SPECIFICATIONS
More informationPossible Noncompliance Review Processing
Possible Noncompliance Review Processing October 31, 2018 RAM-200 3000 Bayport Drive, Suite 600 Tampa, Florida 33607-8410 (813) 289-5644 - Phone (813) 289-5646 Fax www.frcc.com Table of Contents Page
More informationSETTING NEW STANDARDS IN TEMPERATURE CONTROLLED SHIPPING DHL AIR THERMONET
SETTING NEW STANDARDS IN TEMPERATURE CONTROLLED SHIPPING DHL AIR THERMONET DHL Global Forwarding Excellence. Simply delivered. YOUR COLD CHAIN SOLUTION TO COVER THE WORLD Transporting temperature-controlled
More informationGLP Compliance Assurance vs. Quality Assurance. Quality Beyond GLP Compliance
GLP Compliance Assurance vs. Quality Assurance Quality Beyond GLP Compliance Jennifer Pangborn Quality Assurance Specialist 1 Outline Why QAU is here? Quality Assurance beyond GLP Compliance Expanding
More informationNSPCC Job Description. To provide high quality facilities management to a designated Division / Region of the NSPCC.
NSPCC Job Description JOB TITLE: FUNCTION: DEPARTMENT: Area Facilities Manager Corporate Services Project and Building Services and Facilities DATE: May 2014 JOB PURPOSE To provide high quality facilities
More informationDigital Slide Sharing and Consultative Strategies and Tactics Pathology Informatics 2011 October 6, 2011
Digital Slide Sharing and Consultative Strategies and Tactics Pathology Informatics 2011 October 6, 2011 Walter H. Henricks, M.D. Cleveland Clinic Digital Slide-based Second Opinion Consult Service Subspecialty
More information