Any of our 700+ standard or custom courses can be translated into a specific ... around the world, join other global com
Global Language Courses
34 Languages: Arabic Chinese (Simplified) Chinese (Traditional) Czech Danish Dutch Nederlands English Finnish Flemish French (Canada) French (France) German Greek Hebrew Hindi Hungarian Indonesian Italian Japanese Korean Malaysian (Malay) Norwegian Polish Portuguese (Brazil) Portuguese (Portugal) Romanian Russian Slovak Spanish (Spain) Spanish (Latin America) Swedish Thai Turkish Vietnamese
Translated Courses UL EduNeering’s learning solutions reflect today’s global business environment. To support our global clients, we have translated many of our popular courses into multiple languages as specified in this brochure.
Custom Translations Any of our 700+ standard or custom courses can be translated into a specific language upon request. If you have subcontractors, research sites and manufacturing operations around the world, join other global companies that rely on ComplianceWire® as their single enterprise-wide compliance learning platform for users in both Asia and Europe.
Global LMS Interface Options ComplianceWire, our exclusive online learning management system, provides the option of enabling users to change their user interface into any of the 34 supported languages.
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DCRI Courses: Audits and Inspections: Identifying Fraud and Misconduct China Food and Drug Administration (CFDA): Clinical Trial Regulation in China CREATe Refresher Course Drug Safety and Adverse Event Reporting Electronic Data Capture
DCRI-04 DCRI-14
Evolution of Clinical Research and Drug Safety
DCRI-01
How is Clinical Research Regulated? Human Research Protection Program Informed Consent – Part 1 Informed Consent – Part II Phases of Clinical Research Recruitment, Retention and Lost to Follow-Up Responsibilities of a Clinical Research Coordinator (CRC) in FDA-Regulated Studies Responsibilities of Investigators Conducting FDA-Regulated Studies
DCRI-03 DCRI-07 DCRI-08 DCRI-09 DCRI-02 DCRI-11 DCRI-05
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DCRI-13 DCRI-10 DCRI-12
DCRI-06
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Ethics Courses: Detecting and Preventing Fraud Conflicts of Interest Foreign Corrupt Practices Act (FCPA) Global Anti-Bribery Handling Confidential Information Privacy and Data Protection
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T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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HR & Environmental Health and Safety Courses: Basic Radiation Awareness Bloodborne Pathogens – Health Care Workers Confined Space Entry Driver Safety Program (DSP)
EHS05 EHS09 EHS15 EHS110
Electrical Safety Ergonomics: Body Mechanics and Fitness Forklift Safety Hazard Communication Hazardous Waste Determination Heat Stress Hot Work Permits Improving Productivity Introduction to Workplace Safety Lockout/Tagout – Authorized Machine Safeguarding Personal Protective Equipment Slips, Trips and Falls
EHS23 EHS33 EHS34 EHS37 EHS38 EHS44 EHS47 EHS49 EHS53 EHS58 EHS59 EHS67 EHS98
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Miscellaneous Courses: Welcome to the ComplianceWire® Platform
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T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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GMP FDA Enforcement Courses: FDA Establishment Inspection Report Writing FDA Good Guidance Practices (GGPs) MDR Regulation 1: Overview and General Provisions MDR Regulation 2: Device User Facility, Importer and Reporting Requirements MDR Regulation 3: Requirements for Individual Adverse Event Reports Part 11: Electronic Records; Electronic Signatures
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FDA26 FDA21 FDA63 FDA65 FDA66 FDA31
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DEV46
PHDV70 PHDV75 DEV54 DEV56
Medical Device Packaging, Labeling and Distribution Meeting GMP Training Requirements Orientation to GMP Compliance Principles of Good Documentation
DEV41 PHDV76 PHDV73 PHA74
Q9: Quality Risk Management Quality Systems Inspection Technique (QSIT) Understanding GMPs for Facilities and Equipment
ISPE09 DEV42 PHDV63
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PHDV74 DEV43
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T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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GMP Medical Device Courses: Complaint Management for Medical Device Manufacturers Design Control Regulations for Medical Device Manufacturers Effectively Responding to FDA 483s and Warning Letters Essentials of an Effective Calibration Program Global Regulatory Strategy and Planning Process Good Documentation Practices for Medical Device Manufacturers Handling an FDA Inspection Introduction to Quality System Regulation (QSR)
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GMP Pharmaceutical Courses: Batch Record Reviews Biotechnology: An Overview of Compliance Considerations Change Control Effectively Responding to FDA 483s and Warning Letters Essentials of an Effective Calibration Program Failure Investigations for Pharmaceutical Manufacturers GMP Principles for Batch Records GxPs Handling an FDA Inspection Introduction to GMPs Maintenance and Cleaning of Drug Manufacturing Equipment Meeting GMP Training Requirements Orientation to GMP Compliance Packaging and Labeling of Finished Pharmaceuticals Principles of FDA Inspections for Pharmaceutical Manufacturers Principles of Good Documentation
PHA53 PHDV68 PHA35 PHDV70 PHDV75 PHA59 PHA60 PHDV61 PHDV74 PHA38 PHA44
Understanding GMPs for Facilities and Equipment Writing and Reviewing SOPs
PHDV63 PHA48
PHDV76 PHDV73 PHA39 PHA61 PHA74 (CA/EU)
T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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Translated Courses
2014 Scheduled Course Translations All of the courses listed are being translated into Simplified Chinese, Japanese and Korean languages in 2014. Those marked with a “ ” are complete as of the publication of this brochure.
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Global Regulatory: Q9: Quality Risk Management – ICH Q9 A Guide to ISO 13485 – The Quality Management System for Medical Devices Global Regulatory Strategy and Planning Process EU Medical Device Directive: Part I — Introduction EU Medical Device Directive: Part II – Specific Procedures The Approval Process for New Medical Devices in the US Design Control Regulations for Medical Device Manufacturers ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials Audits and FDA Inspections: Pre- and Post-Approval FDA Inspections Principles of Auditing Handling an FDA Inspection QSIT 4: The Corrective and Preventive Actions Subsystem Quality System Inspection Technique Risk Management 1: Key Concepts and Definitions Complaints, Recalls and FDA MDR Regulations: Handling a Product Recall Failure Investigations for Medical Device Manufacturers Complaint Management for Medical Device Manufacturers The MDR Regulation 1: Overview and General Provisions MDR Regulation 2: Device User Facility, Importer and Reporting Requirements MDR Regulation 3: Requirements for Individual Adverse Event Reports FDA Quality System Regulation (QSR): Introduction to the Quality System Regulation (QSR) QS Regulation 3: Design Controls QS Regulation 5: Identification & Traceability; Production and Process Controls QS Regulation 7: Corrective and Preventive Action QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution and Installation
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ISPE09 DEV50 DEV54 MDD01 MDD02 DEV47 DEV40 GCP03
PHDV66 PHDV69 PHDV74 FDA53 DEV42 FDA29 PHDV64 DEV45 DEV46 FDA63 FDA65 FDA66
DEV43 QSR03 QSR05 QSR07 QSR08
FDA Import Operations: Import Operations 1: Background Import Operations 2: The Process Import Operations 3: Other Activities
FDA37 FDA42 FDA43
GMP Key Concepts: GMP Principles of SOPs Key Concepts of Process Validation Essentials of an Effective Calibration Program FDA Training and Qualification Requirements Environmental Control and Monitoring Risk Management 1: Key Concepts and Definitions
PHA64 PHDV77 PHDV75 PHA67 PHDV87 FDA29
T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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About UL EduNeering UL EduNeering is a business line within UL Life & Health’s Business Unit. UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. 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.
T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
202 Carnegie Center Suite 301 Princeton, NJ 08540 609.627.5300 UL and the UL logo are trademarks of UL LLC © 2014.
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