'Qms' trends
Domains containing the tag 'Qms'
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- 1schematicsunlimited.com
Schematics Unlimited :: Free Diagrams, Schematics, Service Manuals for download
Free Diagrams, schematics, service manuals from: 3Com, ABB Goerz, ABI Electronics, Accuphase, Acer, Acoustic Research, Acoustic, Acrosound, Acurus Mondial Designs, Ada Rocket, Adcom, Addison, Admiral, Adret, Advantest, AEL, Aes Reprints, Agilent, Aguilar, Ailtech, Aims, Aircastle, Airline Wards, Aiwa, Akai, Akira, Alamo, Alba, Alesis Matica, Alesis, Alfa Romeo Vehicles, Allen And Heath, Allesandro, Altec Lansing, Alto, Amcron, Ameritron, Ampeg, Ampex, Amp Supply Company, Amstrad, ***ogic, Anritsu, Antenna Mart, Antique Sound, AOC, Aound, Apex, Apt Holman, Arcam, Arcelink, Aries, Ars Aures, Asco, Ashdown, Ashton, Astron, Asus, Attack, Audible Illusion, Audio Critic, Audio Innovation, Audio Research, Audiolab, Audion, Audionote, Audiotec, Audioton, Audiovox, Audio Technica, Austin, Australian Monitor, Austrovox, Avance, Avantek, Averatec, Avery Fisher, Avo, Awa, A***ion, Backstrom, Badcat, Ballantine, Bang Olufsen, Bardon, BBC Goerz Metrawatt, Behringer, Beko, Bell Telephone, Bell, Belmont, Belson, Benq, Berkeley, Berning, Binson, Black Box, Blaupunkt, BMW Vehicles, Bogen, Bogner, Boonton, Bose, Boss, Bowers Wilkins, Brand X, Braun, Brian May, Broksonic, Brook, Brother, Browning, Bruel Kjaer, Bryston, BSS, BTE, Buick Vehicles, Burman, Bush, C Audio, Cadillac Vehicles, Calsel, Camaro Vehicles, Cambridge Audio, Camco, Canadian Noname, Canon, Carlsbro, Carlton, Carver, Carvin, Casio, CCE, Cello, Cerwin Vega, Cessna, Challenger, Chameleon, Chevin, Chevrolet Vehicles, Chrysler Vehicles, Ciclotron, Cineral, Citation, Citronic, Clairtone, Clarion, Clarke Hess, Clarostat, Classe, Clatronic, Clevo, Cloud, CMS, Colorsound, Compal, Compaq, Conrad Johnson, Copland, Counterpoint, Coutant Electronics, CPT, Craftsmen, Crate, Crest, Crown, CT Systems, Curtis Mathes, Cygnus, Cyrus, Daetron, Daewoo Vehicles, Daewoo, Dallas Arbiter, Dancom, Danelectro, Dano, DarTZeel, DATASHEETS, Datron, Datsun Vehicles, Daytek, DDA, Dell, Delta Elektronika, Denon, Desoto Vehicles, Dewald, ***erson, Disney, Dod, Dodge Vehicles, Dokorder, Dolby, Don Mcgohan, Doxa, DPA, Drake, Dr K Witmer Electronik, Dukane, Dumb Bell, Dumble, Dumont, Duncan, Dunlop, Duraband, Dynaco, Dynacord, Dynex, Earth, Eastern, Echoplex, Ecler, Eddystone, Edison, Egnator, Eico, EIP Phasematrix, Ekosonic, Electar, Electro Harmonix, Electro, Electrocompaniet, Electrohome, Electromuse, Electroplex, Electrovoice, Elektro Automatik, Elgen, Elite, Elk, Emerson, Engl, Epiphone, Epson, Erae, ESI, Esoteric Teac, Eurocom, Farnell, FBT Elettronica, Fender, Ferguson, Fiat, FIC, Filterless, Firs***t Pass, Fischer, Fish, Fisher, Fleetwood, Fluke, Fonica, Ford Vehicles, Formenti, Fostek, Fourier Components, Frank, Fujitsu, Funai, Futterman, Gallienkrueger, Garnet, Gas, Gateway, GCS, GE, Gemini, Genelex, General Electric, General Radio, Genesis, Genicom, Geospace, GGG, Gibson, Giga Tronics, Global Specialties Corp, GMC Vehicles, Goerz Electro, Golden Audio, Golden Tube Audio, Goldentone, Goldstar, Goodmans, Gossen, Gotham Audio, Gould, Gradiente, Gran Amplifiers, Grant, Gregory, Gretsch, Greynolds, Grommes, Grommesprecision, Groovetube, Grundig, GT, Guild, Hafler, Hagstrom, Haier, Hallicrafters, Hameg, Hammond, Harley Davidson Vehicles, Harman Kardon, Harmony, Harris, Hartke, Hartmann Braun, Hatcher, HDW, Head Phone, Heathkit, Hendrix, Henrys, HGL, HH Scott, HH, Hickok, Hill Audio, Hioki, Hisense, Hitachi, Hiwatt, HK, Hodaka, Hohner, Honda Vehicles, Honda, Hotz Gerber, HP, HP Agilent, Hudson Vehicles, Hughes Kettner, Huntron, Ibanez, Icom, IFR, IMC, Impact, Integra, Inter M, Internec, IOtech, Isotech, ITT, J Marshall Leach, Jadis, Jaguar Vehicles, Japan, JBL, JE Labs, Jeep Vehicles, Jen, Jim Kelly, Jimi, JMC, JMF, Jolida, Jordan, JPS Associates, Jungson, JVC, Kalama***, Kawasaki Vehicles, Kay, Kebschul, Keithley, Kendrick, Kent, Kenwood, Kingshill, Kittyhawk, Klein And Hummel, Klemt, KLH, Klipsch, Knight, Koda, Kodak, Komet, Kondo, Konica Minolta, Konzertmeister, Korbet, Korg, Kramer, Kustom, Kuzma, Kyocera, Labgruppen, Lafayette, Lambda, Laney, Langevin, Lasermatrix, Lava, Leak, Lecroy, Lecson, Lectrolab, Lenco, Lenovo, Leslie, Lexicon, Lexmark, LG, Lincoln Vehicles, Line 6, Linn, LJ Electronics, London City, London Electric, Lotus, Lowther, Luxkit, Luxman, Mackie, Maestro, Magnatone, Maplin, Marantz, Marconi, Mark Audio, Mark Levinson, Marshall, Martin Audio, Martin, Masco, Matchless, MC2 Audio, MCC, Mcgohan, Mcintosh Misc, Mcintosh, Meazzi Factotum, Meissner, Mercedes Vehicles, Mercury Vehicles, Mercury, Mesa Boogie, Metaltronix, Metro, Metrosound, MFA, Michaelson Austin, Midas, Miltec, Mindprint, Mini Vehicles, Mitac, Mitsubishi Vehicles, Mitsubishi, Mitsubishi Vehicles, Moog, Morley, Morris, Mosrite, Motorola, Mullard, Multivox, Musical Fidelity, Musicman, MXR, Nad, Naim, Nakamichi, Nash Vehicles, National Horizon, NEC, Neumann, Newcomb, Newcombe, Newport, Nikko, Nissan Vehicles, Nissan, NLS, Nobels, Nokia, Nomad, Nordmende, Noritake, Northern Electric, Novatech, Nyal Futterman, Oberheim, Ohm, Okidata, Oldsmobile Vehicles, Olevia, Olson, Oltronix, Onkyo, Orange, Orban, PA Sjostrom, Packard Bell, Paia, Panaramic, Panasonic, Panasonic Matsu***a, Park, Parmeko, Pax, Pearl, Peavey, Pederson, Phase Linear, Philbrick, Philco, Philips, Phone, Phonic, Phonola, Pignose, Pilot, Pioneer, Plessey, Plymouth Vehicles, Pontiac Vehicles, Porsche Vehicles, Portable, Precision Apparatus, Precision Electronics, Precision Fidelity, Prema, Premier, Proceed, Proco, Proel, Proline, Promac, Proton, Purple Cow, PYE, QMS, QSC, Quad, Quasar, Racal, Racal Dana, Radford, Ram Audio, Randall, Rane, Ray Massie, RCA, Redbear, REL, Renkus Heinz, Revere, Revox, Rickenbacker, Ricktone, Ricoh, Ringing, Riser Bond, Rivera, Roberts Radio, Rock Ola, Rocktek, Roger Mayer, Rogers, Rohde Schwarz, Roland, Rotel, Rumble, Rycom, SAC, SAE, Samick, Samson, Samsung, Sano, Sansui, Sanyo, Scott, SDS Labs, Selmer, Sencore, Sennheiser, Seymour Duncan, Sharp, Sherwood, Shin Ei, Sho Bud, Shure, Silvertone, Simms Watts, Sinclair, Singer, Sireko, SJB, Soft, Solartron, Soldano, Solton, Sonocraft, Sony, Soultone, Sound City, Sound Dragon, Soundcraft, Soundcraftsmen, Sovtek, Sparton, Sphinx, Sprague, SRS, Stageline, Standel, Stark, Stax, Stereo, Stereomaster, Stereotech, Storno, Stromberg Carlson, Studer, Studiomaster, Sugden, Sumo, Sun, Sundown, Sunn, Supro, Suzuki Vehicles, Swissecho, SWR, Tag Mclaren, Takeda Riken, Tandberg, Tannoy, Teac, Technics, Teisco, Tektronix, Telecoms, Telefunken, Telequipment, Telewatt, Telonic, Telray, Tenma, Texscan, The Link, Thomson, T***ns, Threshold, Titan, Tophat, Torres, Toshiba, Toyota Vehicles, TP Radio, Trace Elliot, Trainwreck, Transatlantic, Transmation, Traynor, Trio, Triplet, Triumph Vehicles, TTi, TV License UK, Twinhead, Ultratone, United Transformer, Univibe, Univox, Uniwill, Urei, UTC, VAC, Valco, Vector, Vespa Vehicles, Vestax, Viking, Void, Volkswagen Vehicles, Volvo Cars, Vox, Wagoneer Vehicles, Wards, Watkins, Wavetek, Webcor, Wells Gardner, Wem, Westbury, Western Electric, Wiltron, Wurlitzer, Xerox, Yaesu, Yamaha, Yaqin, Yorkville, Zebra, Zen, Zenith all free to download
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- 2iso9001help.co.uk
ISO 9001 Help - Home
ISONavigator provides free, online training on ISO 9000:2000. Buy an ISO 9001 quality manual template.
Whether you're implementing processes to satisfy customers or to improve efficiency, our ISO 9001:2015 quality manual templates and internal audit checklists can help
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- 3deffinity.com
Deffinity Project Delivery
Project Management Project Delivery Service Delivery Resource Planning Resource Management Audits Tender Management Vendor Management Inventory Management Timesheets Training Management RFI, RFP, Finance, P&L, Issues, Risks, Do***ent Management, Quality Control, Quality Management, QMS, Integrated Solution, Service Management, ITIL, Prince-2, Prince2, Cloud Computing, SaaS, Online Project Management, Healthchecks, Asset tracking, asset management, Collaboration, Team working, Service Delivery, Project accounting, project billing, project control, project tasks, task management, resource planning, change control, continuous improvement, simplifying IT, Bill of Materials, Invoicing, Variations, Valuations, customer feedback, task monitoring, task planning, Integration customer portal customer dashboard, online reports,
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- 4iweb.online
iWeb Enterprise Suite :: Empowering Agility - Cloud ERP | SaaS | LessCode | Edtech | IUMS | EMS | Campus Automation | Freemium
iWeb Enterprise Suite :: Empowering Agility with Cloud ERP | SaaS | LessCode towards - Education | Edtech | Edutech verticals using AI & Blockchain & IOT on Public Cloud on a unique FREEMIUM Model.
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- 5inkmaxhk.com
inkmaxhk.com
Ink and toner cartridges, made in China, wholesale online, UP TO 75% OFF, Express service 3-4 days.Inkmaxhk aims to provide a fast, easy and secure online shopping for our customers, mostly computer-supply distributors. We cover a wide range of compatibles including HP, Epson, Canon, Lexmark and more. And these products are 100% compatible to the originals. As an ISO9001 certified factory, we stand behind our products, quality and service wise.……
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- 6examtrack.co.uk
ExamTrack - Graded Qualification Management System
Software developers of awarding body qualification management systems
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- 7consense-gmbh.de
ConSense GmbH – Die Software für Prozess- und Qualitätsmanagement: ConSense
Neben Beratung und Schulung wird ein Komplettsystem zur Erstellung und Pflege von elektronischen Managementdokumentationen (QMS/IMS) angeboten. [D-52146 Würselen]
Softwarelösungen für Qualitätsmanagement-, Prozessmanagement- und Integrierte Managementsysteme der ConSense GmbH – branchenübergreifend & ganzheitlich.
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- 8uds-beratung.de
Schulung & Zertifizierung für Brandschutz & Sicherheit | UDS Beratung
Zertifizierung für Brandmelde-, Sprachalarmanlagen, Sicherheitsdienstleister & mehr. Wir bieten Schulungen mit erfahrenen Referenten ➨ Jetzt informieren!
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- 9ecompliance.co.jp
イーコンプライアンス トップページ
製薬・医療機器業界における品質保証、QMS構築支援、PIC/S GMP、CSVやER/ES対応に必要なドキュメントや書籍、セミナーをご提供。
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- 10orgavision.com
orgavision
orgavision | Softwarelösung für Qualitätsmanagement, Unternehmensdokumentation, Dokumentenlenkung, Integriertes Management-System (IMS) & QM-Handbuch. Hosted in Germany.
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- 11audiso.cz
AUDISO a.s.
Certifikační orgán pro certifikaci QMS, EMS, SM BOZP dle ISO 9001, ISO 14001 a OHSAS 18001.
Certification of Management Systems QMS, EMS, OHSAS, ISMS, IT services, Road quality management, SUCO, energy management, ISO 3834 Welding Inspection.
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- 12colorgrafix.com.br
Colorgrafix Color Toner
Consumibles, repuestos y cartuchos para impresoras.
Toner, Xerox, Konica Minolta , Ricoh, Bizhub, Xerox 560, Xerox 700i, Xerox 770, 70HC, Xerox 700 Xerox 570, Xerox C60, Versant, Xerox 1000, Xerox J75, Xerox C75, Compatível, Impressora, Original, Xerox,Importação de Máquinas,Toner, Color, laser, Mono, Cartucho, Cartridge, Colorido, Compatível, Impressora, Original, Xerox, Ricoh, Konica, Okidata, Workcentre, Docucolor, Phaser, Afico, MPC, Magicolor, Minolta, Bizhub, QMS, Oki, Brother, Canon, Epson, Savin, Samsung, Fuji Xerox, Gestetner, HP, Infotec, Kyocera, Lanier, Lexmark, Océ, Olivetti, Panassonic, Pitney Bowes, Refil, Sharp, Tally, Toshiba, Xanté, MP, MC, MB, X550, X560, X570, X700i, C60, C70, C75, C2128, 2240, 240, 250, 252, 260, J75
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- 13urs-me.com
URS Middle East - Offering ISO Certification of Management Systems, Inspection Services and Training - United Registrar of Middle East, Dubai, United Arab Emirates | Offering Certification and Training of various Quality Management Systems in the entire Middle East region
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- 14qmsmodeltown.com
:::Queen Mary School | Queen Mary's School | Qms Model Town:::
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- 15psikologi-islam.com
Lembaga Bantuan Psikologi Islam Indonesia
Lembaga Bantuan Psikologi Islam Indonesia
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- 16printerrepairs.com.au
National Printer Repairs - Australia's laser printer repair & service specialists - Home
National Printer Repairs are Australia's laser printer repair and service specialists based at Milperra, in Sydney.
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- 17iso9000conference.com
American Quality Institute - AQI
The ISO 9000 World Conference is the first, and the longest running conference on ISO 9000 & Related Standards. and attracts top experts and quality management professionals from around the world. The Conference, organized by the American Quality Institute (AQI), will be held in Nashville, TN, on March 27-28, 2017. This year’s conference will provide the knowledge organizations need to proceed with their transition to ISO 9001:2015. A combination of workshops, case studies from organizations who have completed the transition, and sessions on specific requirements of ISO 9001 from experienced quality professionals and standards experts are sure to provide those needed insights. Sector specific standards will also be part of this year’s conference program. In-depth sessions on ISO 13485, AS9100, and IATF 16949. Industry experts will explain the changes with timely and relevant information that attendees can use to complete their transition for these standards as well. No conference is complete without tools to enhance the management system. Risk-based thinking continues to be a topic of discussion. Sessions have been planned to present a variety of perspectives on this topic. Presentations on auditing will also provide tools on how to add value to the organization.
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- 18deepstore.ru
DeepStore
Âåñü ñïåêòð îáîðóäîâàíèÿ Apple, àêñåññóàðû, ìîíèòîðû, ïðèíòåðû, ñêàíåðû, öèôðîâûå êàìåðû, ðàñõîäíûå ìàòåðèàëû
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- 19bss.com.au
Business Smart Solutions - Queue Management System - Cheque Processing System
BSS as a System Integrator provides excellent IT solutions in a wide range of products. With Integrated Multimedia Queue Management Solutions SMARTQUEUE, BSS has provided an integrated solution to improve queue management, service performance and customer satisfaction.
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- 20qualityze.com
Enterprise Quality Management Systems | EQMS Software | Qualityze Inc
Qualityze offers enterprise quality management software systems for life sciences, manufacturing, a***pace, ***s, healthcare, medical devices industries
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- 21rezepturforum.de
Rezepturforum
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- 22quantum-kw.com
Home | Quantum
Quantum Inc., is a leading regional Information and Communication Technology Company based in Kuwait provides a unique IT consultancy, Services and Solutions.
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- 23qt9qms.com
QT9's Quality Management Software (QMS) automates workflow and synchronizes processes to simplify compliance. Try QT9™ QMS Software FREE for 30 days.
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- 24versasys.cz
Úvodní - Versa Systems je specializovaná konzultační firma.
Specializovaná konzultační firma s orientací na management podnikatelských procesů, integrované systémy řízení a systémovou integraci.
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- 25amtis.com.my
AMTIS Solution Sdn Bhd
Our company is 100% bumiputera company focusing on the ICT industry
specializing in providing solutions in information and knowledge.We acquired the essential capability, knowledge
and human resources to further enhance the ICT industry such as Software Development, Graphics
Design, Consultation, ICT Training and System Integration. Kursus PHP & MySQL 100% Secara Praktikal. Yuran Termurah. HRDF Claimable. Tempat Belajar Yang Selesa Dan Berkualiti. Tenaga Pengajar Berpengalaman. amtis.com.my adalah Sebuah Training Center Yang Anda Boleh Gunakan Untuk Membuat Sebarang Jenis Kursus atau Seminar. Syarikat kami adalah syarikat 100% bumiputera memberi tumpuan kepada industri ICT khususnya dalam menyediakan penyelesaian maklumat dan pengetahuan dalam. Kami memperoleh keupayaan penting, pengetahuan dan sumber m***ia untuk meningkatkan lagi industri ICT seperti pembangunan perisian, Grafik Design, Perundingan, Latihan ICT dan penyepaduan sistem.
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- 26isochennai.com
ISO Chennai | ISO 9001 Certification Consultants in chennai
A Leading iso traning courses in chennai.
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- 27spmcpk.com
Services, Products & Environmental Management Consultants - ***stan
We are an environmental services consulting firm based in Karachi, ***stan.
We provide environmental engineering management services and products.
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- 28paragonqmsglobal.com
ISO Standards | Greater London Business | Paragonqms Ltd
paragonqms ISO Standards consultancy auditing certification provider of iso do***ent like manual
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- 29regulatory.com.ua
Pattern of USA Inc. | Regulatory Affairs Outsourcing ft Pattern of USA Inc. Homepage, FAQ
510(k) – Premarket Notification for Medical Device aka PMN
AADA – Abbreviated antibiotic drug application
ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
AE – Adverse event
AIM – Active ingredient manufacturer
AIMD – Active implantable medical device
ANDA – Abbreviated new drug application
API – Active *** ingredient
AR – ***sment Report (European Union)
ASMF – Active Substance Master File
ATMPs – Advanced therapy medicinal products
BA – Bioavailability
BAP – Biotechnology Action Program
BIND – Biological investigational new drug
BLA - Biologic License Application
BWP – Biotech Working Party (EMA)
C&P – Chemistry and ***
CA – Competent authority
CANDA – Computer assisted new drug application
CAP – Centrally authorized product
CAPA – Corrective action and preventive action
CAPLA – Computer Assisted Product License Application
CCDS – Company core data sheet
CD – Controlled drug
CDSCO – Central Drug Standard Organization (India)
cGLP – Current good laboratory practice
cGMP – Current good manufacturing practice
Cl – Total body clearance
CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
CMP – Certificate of Medicinal Product
COA – Certificate of ***ysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
CP – Comparability protocol (USA)
CPP – Certificate of *** product
CQA – Clinical quality assurance
CR – Controlled release
CRO – Clinical Research Organization
CSI – Core safety information
CSP – Core safety profile
CSR – Clinical study report (European Union)
CT – Clinical trial
CTA – Clinical trial application
CTA – Clinical trial authorization
CTD – Clinical Trials Directive
CTD – Common technical do***ent/dossier
CTMS – Clinical trial management system
CTS – Common technical specification
CVM – Center for Veterinary Medicine (US)
DACS – Detailed and critical summary
DAE – Discontinuation due to an adverse event
DDPS – Detailed description of pharmacovigilance system
DMF – Drug master file
DMS – Do***ent management system
DP – Drug product
DS – Drug substance
DSUR – Development safety update report
EA – Environmental ***sment
EC – Ethics committee
eCTD – Electronic common technical do***ent
EDMF – European drug master file
EDT – Electronic data transfer
ENS – Early notification system
EPA – Environmental Protection Agency
EPL – Effective patent life
ePSUR – Electronic periodic safety update report
ERB – Ethical review board
ESPAR – Executive Summary Pharmacovigilance ***sment Report
EUA – Emergency Use Authorization
EWG – Expert Working Group
EWP – Efficacy Working Party
FAR – Final ***sment report
FMEA – Failure mode and effects ***ysis
GCP – Good clinical practice
GDP – Good distribution practice
Generic - Generic drug
GGP – Good guidance practice
GLP – Good laboratory practice
GMP – Good manufacturing practice
GMP – Good management practice
GPP – Good pediatric practice
GPP – Good pharmacoepidemiology practice
GpvP – Good pharmacovigilance practice
GRB – Global Regulatory Board
GRP – Good regulatory practice
GSL – General sales list
GSP – Good statistics practice
GVP – Good pharmacovigilance practice
HCP – Healthcare professional
HEOR – Health economics and outcomes research
HREC – Human Research Ethics Committee
HTA – Health technology ***sment
IB – Investigator’s brochure
IC – Informed consent
ICD – Informed consent do***ent
ICSR – Individual case safety report
IDE – Investigational Device Exemption
IDMP – Identification of medicinal products
IEC – Independent ethics committee
IM – Issue management
IME – Important medical event
IMI – Innovative Medicines Initiative
IMP – Investigational medicinal product
IMPD – Investigational medicinal product dossier
IMRDF – International Medical Device Regulatory Forum
IMS – Information management strategy
INDA – Investigational new drug application (USA)
INDC – Investigational New Drug Committee
IP – Intellectual property
IPO – Intellectual Property Office
IPR – Intellectual property rights
IQM – Integrated quality management
IRB – Institutional review board
IRD – International registration do***ent
IRN – Incident Review Network
IS – Internal standard
ISE – Integrated summary of efficacy
ISRB – Integrated summary of risk benefit
ISS – Integrated summary of safety
KIT – Key intelligence topic
KM – Knowledge management
KOL – Key opinion leader
LCM – Lifecycle management
LLL – Lifelong learning
MA – Marketing authorization
MAA – Marketing authorization application (EU)
MAH – Marketing authorization holder
MAIL – Medicines Act Information Letter (UK)
MAL – Medicines Act Leaflet (UK)
MDCG – Medical Device Coordination Group
MDD – Medical Device Directive
MDEG – Medical Device Expert Group
MDLO – Medical Device Liaison Officer
MDR – Medical device reporting
MERS – Multi-agency electronic regulatory system
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
ML – Manufacturer’s license (UK)
MOU – Memorandum of Understanding
MRA – Mutual recognition agreement
NAP – Nationally authorized product
NBE – New biological entity
NCE – New chemical entity
NCO – Non clinical overview
NCS – Non clinical summary
NDAC – New Drug Advisory Committee (India)
NIMP – Non-investigational medicinal product
NME – New molecular entity
OD – Orphan drug
ODA – Orphan *** Act (USA)
ODD – Orphan drug designation
OIA – Official action indicated
OOS – Out of specification
OTC – Over-the-counter ***
P&R – Pricing and reimbur***t
P – *** only
P to GSL – *** to General Sales List
PA – Product authorization
PAI – Pre-approval inspection
PAR – Preliminary ***sment report
PASS – Post authorization safety study
PAT – Process ***ytical technology
PDE – Personal daily exposure
PER – *** evaluation report
PGD – Patient group direction
PI – Prescribing information
PI – Production information
PIL – Patient information leaflet
PIM – Product information management (EMA)
PIP – Pediatric investigation plan
PMS study – Post-marketing safety study
PMS – Postmarket(ing) surveillance
POM – Prescription-only medicine
POM to P – Prescription-only medicine to ***
PPI – Patient and Public Involvement (UK)
PRSPH – Potential serious risk to public health
PSMF – Pharmacovigilance system master file
PTE – Patent term extension
PUMA – Pediatric-use marketing authorization
PV – Pharmacovigilance
PVAR – Preliminary Variation ***sment Report
QA – Quality assurance
QbD – Quality by design
QC – Quality control
QMS – Quality management system
QOL – Quality of life
QoS – Quality overall summary
QP – Qualified person
QPPV – Qualified person for pharmacovigilance
QRD – Quality review of do***ents [template]
RA – Regulatory affairs
RAPS - Regulatory Affairs Professionals Society
RCFID – Registration Certificate for Import of Drug
RCT – Randomized controlled trial
RDE – Remote data entry
RDS – Repeat dose study
RDT – Rising-dose tolerance
REACH – Registration, evaluation, authorization, restriction of chemicals
RI – Regulatory intelligence
RING – Regulatory Intelligence Network Group
rINN – Recommended international non-proprietary name
RMM – Risk minimization measure
RMP – Reference medicinal product
RMR – Reaction monitoring report
ROI – Return on investment
RoW – Rest of world
RP – Responsible person
RPS – Regulated product submission
Rx – Prescription
S+T – Sampling and testing
SAG – Scientific Advisory Group
SAP – Scientific advice procedure
SAWP – Scientific Advice Working Party
SI – Statutory instrument
SLA – Service level agreement
SME – Significant medical event
SMF – Site master file
SMO – Site management organization
SMQ – Standardized MedDRA query
SOP – standard operating procedure
SPIN – Special interest network
SSC – Scientific Steering Committee
TAG – The***utic Advisory Group
TLV – Threshold limit value
TOC – Table of contents
TOD – Table of decisions
TOPRA – The Organization for Professionals in Regulatory Affairs
TPP – Target product profile
USDA – United States Department of Agriculture
VAI – Voluntary action indicated
WC – Written confirmation
WL – Wholesale dealer’s license
WRAC – Worldwide Regulatory Affairs Committee
WHO - World Health Organization
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- 30kktotal.co.jp
株式会社トータル|システム構築、ソフトウェア開発、ISO・Pマーク認証取得支援
株式会社トータルは、QMS EMS ISMSといったISO認証取得コンサル支援、プライバシーマーク(PMS)認定取得コンサル支援を行っている企業です。
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