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d! 100% Success Rate 60-90 days |
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The following links provide useful information (consulting, training, and certification steps) for each of the standards/regulations as well as frequently asked questions such as definitions, latest standards, benefits, timelines for certification, and links to online training.
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AccelCert provides Training, Consulting, Certification, Automation, On Site Training, Online Training, Customized Training, Internal Audits, Acquisition Audits, Supplier Audits, FDA Audits and GMP Audits for worldwide standards |
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Our Services AccelCert provides consulting, training, and certification services for all standards and regulatory requirements: Our services include the following: Consulting/Training/ Certification Services:
Our experts work with key staff to advise, coach,
mentor, and guide them in the process of integrating Internal Audit/ Certification Maintenance: You can subcontract internal auditing. We have qualified and accredited lead auditors in USA and Worldwide who can provide internal auditing services. This can reduce costs for certification and certification maintenance. Online Training: You can save up to 60% by taking online training through Quality University - qualityuniversity.com. Supplier Audits: We help to Identify, Evaluate and Qualify suppliers in USA and Worldwide. We can also monitor suppliers worldwide from our local auditors. We also provide a guarantee for our Supplier Management Program. This can save and reduce costs. Business Acquisition/Merger Audits: We can evaluate all businesses for Acquisitions and Merger. FDA/CGMP Compliance Audits: We can help to achieve FDA and CGMP Compliance including all type of LABS and Software. We also performs FDA/CGMP Internal Compliance Audits. We also help to set-up software design and validation processes in Compliance with FDA, CGMP, Health Canada, SEI, CMM and others standards. Start-Up/New Business Infrastructure Setup: We can help you to set-up infrastructure for complete operation and any function needed. Software Verification and Validation FDA QSR/GMP, ISO 13485 Audit DA QSR/GMP, ISO 13485 Implementation Assistance Design Control Compliance Risk Assessment/Hazard Analysis 510(k) PMA IDE CE Mark Electronic Recordkeeping IEC 60601 Compliance FDA Submissions: 510(k) IDE, PMA, Product Reports Software Quality Compliance Medical Device License Submissions FDA 483 & Warning Letter (response & resolution support) CGMP Compliance FDA Registration Agent for Non-USA Firms Medical Device Reporting (MDR) Post Market Surveillance CE Marking European MDD 90/385/EEC CE Marking European MDD 93/42/EEC CE Marking European MDD 98/79/EEC HACCP (General) Seafood HACCP Dairy HACCP Juice HACCP Retail HACCP Meat HACCP Poultry HACCP Hazard Communications Hazardous Materials Transportation Material Safety Data Sheets Office Ergonomics US DOT Hazardous Materials Transportation Training Lockout Tagout (OSHA) Hazard Communications Personal Protective Equipment Forklift Injury and Illness Prevention Program Emergency Response and Fire Safety Biosafety and Bloodborne Pathogens Hazcom and chemical safety Chemical Waste Management Basic Safety Orientation Training Emergency First Aid and CPR Chemical Spills Confined Space Entry Emergency Response Course Modules Entrenamiento Para Montacargistas-Forklift Environmental Health Risk Assessments Lockout Tagout in Spanish Lockout Tagout Verify Awareness Hazardous communication Training Hazardous Materials Management Intro to Forklift Safety OSHA Hazard Communications OSHA's New Ergonomics Standard 29 CFR 1910.900 Risk Management The Hazardous Matreial Regulation Workplace Ergonomics Workplace Hazard Management Identification, evaluation, and analysis of significant aspects for meeting ISO 14000 needs. Contingency Planning Risk Assessment using FME Approach Risk Assessment/Hazard Analysis HAZMAT Internal Audits CGMP Audits Supplier Audits Regulatory Compliance Audits |
Our
"Very informative and easy to follow." - Adam Preston, Magnolia Beef Company
"It is simple and clear enough and is an excellent introductory to the FDA CGMP. It is easy to reach and use." - Perpetua Nnani, Private Consultant
"Very helpful and useful and a quick logon and download." - Xincai Qiao, JCP Marine Pte Ltd, Singapore
"Easy to read and easy to understand." - John Knapko, SPX Filtran
"I like it very much because of the quality of information." - George Merette, Magnilia Beef Company
"Course content is super user-friendly and easy to read, understand, and find what i need." - Matheus Myndhart, Sasol, Abu Dhabi
"The course was alot of fun. Provided quick and right to the point information." - Vincent Serra, BIS
"It was easy to access, well-coordinated, and flexible." - Innocent Oriarebun
"Provide insight in developing audit questions to effectively validate ISO 13485." - Carl Ritnour, Delta Group Electronics, Inc.
"I like that I could come back to the training I wanted to finish. It was easy to use." - Victor Flecha
"Comprehensive and easy to follow, user friendly." - Adetokunbo Adeyemo, ILF Consultign Engineers, Abu Dhabi
"Direct and too the point and not too time consuming." - LuDean Warren, Lofthouse
"Very easy to use and not confusing, straight to the point." - Toni Lubbers, Lubbers Safety Consulting
"The website is easy to use and re-use. I liked the fact that I could work at my pace and leave and return as needed throughout my workday. The course was complete and concise, everything was easy to find and use." - James Hutchinson, American Medical Systems
"Informative and very easy to use. Easy to learn" - Biju Mathew, PMDC, Dubai
"Very easy to use. Easy to understand." - Darius Thomas
"Easy to navigate through different pages. Covers all aspects of ISO 14001/EMS and I could follow it step by step with ease." - Kailash Chadra Joshi, JCP Marine
"Simple and Straight lessons, simple English language, information and simplified test. Please offer some more courses on Maritime Field." - Kollengode Venkatachalam Krishnan, JCP Marine Pte Ltd
"Took three courses and found courses content are excellent, straight forward, straight to the point and concise, short and to the point." - Ralph Soto, Ganaderos Alvarado Inc
"Able to use at my own pace, good training course content and could come back to at any time when my time allowed. " - Judy Ellett, CBI-Biotech
"Ease of use was Excellent. It was really convenient for me. I could do it on my own time after work. I liked how you could follow the question through the chapters " - Nathan Williams, FedEx
"Ease of use was Excellent. It was very easy to use. It was detailed enough for certification, yet it was presented simply." - Janet Kotsiris, DriveSol Global Steering
"Easy to use and move around and to back up and review before taking quiz." - Gerald Timmerman, Flow Dynamics
"Ease of use Excellent. Very easy to find what you need. Very easy to understand and relate to. " - Elizabeth Bass, Quality Assurance Manager
"Ease of use-Excellent. Easy to follow, easy to understand. " - Amed Ayubi, Beckman Coulter Inc.
"Ease of use- Excellent. It was user friendly. It was clear. " - Naeleen Rosario, IQ Medical Services
"Course Content is excellent; the training slides are comprehensive and easy to read." - Albert Tam, Fast gen
"Course groupings under relevant categories and under specific certification. Information provided in a simple, concise, easy to comprehend, remember format. Didn?t have many filler words straight info. Seemed like a good introduction to the basic premise of the standard." - Donna Beerman |
Our Clients Examples: Port of Oakalnd and Oakland Airport achieves ISO 9001(California) PDS Engineering achieves AS 9100 (Seattle, Washington) Bondcote Facilities achieves ISO 14001 (Virginia) M&C achieves ISO/TS 16949 (Pennsylvania) SSI achieves ISO/TS 16949 (Detroit,Michigan) DataPoint achieves ISO 17025:2005 (South Carolina) Best Lab achieves ISO 17025:2005 (North Carolina) All-Rite Industries achieves ISO/TS 16949 (Illinois) SRC achieves ISO 9001:2008/ (Atlanta,Georgia) Sigmatron achieves ISO 9001 (Nevada) Camnet achieves ISO 9001 (Utah) Vactech achieves ISO 9001 (Arizona) Adkev achieves ISO 9001 (Indiana) Bayer Cropscience Institute achieves HACCP (West Virginia) Technical Services achieves ISO 9001 (Alaska) Emulex achieves ISO 9001 (Puerto Rico) EY Lab achieves ISO 13485 (Hong Kong) Myers achieves ISO 9001 (Oregon) Logistix achieves ISO 9001 (Colorado) Monster achieves ISO 9001 (Mexico) Monster achieves ISO 9001 (Nevada) Metal Works achieves ISO 9001 (Alabama) Prospects achieves ISO 9001 (Wisconsin) Ex Mov achieves ISO 9001 (New Jersey) SVK achieves ISO 13485 (Tennessee)
Pinnacle Telecommunications
Facilities achieves
TL 9000 Bentley Prince Street achieves ISO 14001 (California) Bentley Prince Street achieves ISO 9000 (California) Top Craft achieves ISO/TS 16949 (Pennsylvania) Diagnostic achieves ISO 13485 & CMDCAS (California) Biogenix achieves ISO 13485 & CMDCAS (California) T Family Estateachieves ISO 9001:2000 (Napa, California) SRC achieves ISO 9001:2008 ( Charleston, South Carolina) SRC achieves CMMI (Charleston, South Carolina) SRC achieves TickIT (Charleston, South Carolina) Sigmatron achieves ISO 9001 (Illinois) Leuze Lumiflex achieves ISO 9001 (Michigan) AT achieves ISO 9001:2000 (Virginia) Base Tech achieves ISO 9001 (Virginia) Technology Ventures achieves ISO 9001:2000 (Detroit, Michigan) Bristal-Myers Squib Pacific Airframe (I ARC Surgical TRW Imar Coffee Company Etc JCP Marine Private Limited Prescotech Industries, Inc. WNS global Services Pro-System Technology, Fremont, CA Protocol, Sunnyvale, CA Pulse Science, San Leandro, CA Q. Logic, Costa Mesa, CA Quadrant Components, Fremont, CA Quattro, Union City, CA R K I Instruments, Hayward, CA Redback Networks, San Jose, CA Rely-On, Fremont, CA Rolls-Royce, Oakland, CA Rorze Automation, Milpitas, CA RR Donnelley, Fremont, CA S D L, San Jose, CA SAIC, San Diego, CA San Ho Tian Co., Taiwan Sanden Mexicana, S.A. de C.V. Xerox, Palo Alto, CA Sanmina Corporation, San Jose, CA Sanyo, Tijuana, Mexico Science Applications International Corporation, Los Altos, CA Scientific Research Corporation, Atlanta, GA Sel Services, San Antonio, TX Semiconductor Group, Irvine, CA Sentir Semiconductor, Santa Clara, CA Shape Memory Applications, Santa Clara, CA Sigmatron International, Elk Grove, IL Sigmatron International, Las Vegas, NV Smith and Nephew, San Antonio, TX Soko America, Los Angeles, CA Solutions Group, Hopewell, VA Sony, Tijuana, Mexico State Circuit, Chino, CA Stellex Bandy Machining, Burbank, CA Structural Composites Industries, Pomona, CA Family estates, Saint Helena, CA Symphonic Optical Technogolies, Fremont, CA Merit Sensor, Santa Clara, CA Metal Corporation, Garden Grove, CA WP Manufacturing, Santa Clara, CA Metal, Blacksburg, VA Mico Industries, Evansville, IN Micro Linear, San Jose, CA Micro-Chem Laboratories, Seattle, WA MEMS Endevco, Sunnyvale, CA Medical, Concord, CA Blue Sky Research, Milpitas, CA Bondcote, Pulaski, VA Cable Craft, Seattle, WA Cal-Spray, Palo Alto, CA Campbell Security, Concord, CA CardioMEMS, Atlanta, GA Care Medical, Walnut Creek, CA Celestica-Parque Ind. Reynosa, C. Postal, Mexico Cemax-Icon, Fremont, CA Chips Express, Santa Clara, CA Coach Services, Elkhart, IN Communication Power Systems, Porter, TX Compax-Anaheim, CA Conex Cable, Dublin, CA Control Distribution, Salt Lake City, UT Corion Group, Stockton, CA Cortex Biochem, San Leandro, CA Craft, Goshen, IN CT Services, San Jose, CA D S T Modules, Santa Clara, CA Delphi Systemas de Energia S.A. de C.V. Deltad, San Diego, CA Auburn, CA Dupont, Phoenix, AZ Duncan Technologies, Gemstone Marketing & Consulting Ltd International Truck and Engine Touchstone Research Lab Roche Derian, Santa Ana, CA Duncan Technologies, Anaheim, CA
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Our Clients Examples: Synplicity, Sunnyvale, CA Technical Safety Services, Berkeley, CA Technology Ventures, Warren, MI Telecom Solution, Lake Forest, CA Telesensory Corporation, Sunnyvale, CA Test Systems, Loveland, CO The Kipp Group, Ontario, CA Top Craft Precision Molder, Warminster, PA Toshiba America Electronic Components, Irvine, CA Tracfone, Medley, FL Trans Western Polymer, Livermore, CA Trimm Technologies, Las Vegas, NV TRW, Los Angeles, CA United Defense, Santa Clara, CA Universal Plastic Molding, Baldwin Park, CA Universal Plastic, Burbank, CA Polycom Huntsman, Oxnard, CA Polymerex Medical Corp., San Diego, CA Precise Flight, Bend, OR Precision Machining, Tracy, CA Prime Services Group, Las Vegas, NV Prime Services Group, Livermore, CA Prime Services Group, Pleasanton, CA Prime Services Group, Sacramento, CA Proctor and Gamble, Sacramento, CA Xerox Corporation, Los Angeles, CA Micro-Technic Tool & Stamping, Santa Ana, CA Mipox International, Hayward, CA Myers Containers, Huntington Park, CA Myers Containers, Portland, OR Myers Containers, San Pablo, CA Myers, Portland, OR Myers, San Pablo, CA Netro Corp., San Diego, CA NVIDIA Corporation, Santa Clara, CA NW Ropak, Eureka, CA OSS, Manhattan Beach, CA Pacific Communication, Torrence, CA Pacific Plastics & Engineering, Soquel, CA ParvoMedics, Sandy, UT Perkin Elmer, San Jose, CA Per-Se Technologies, San Bernadino, CA Phototheraputics, Vancouver, Canada Pillar Data Systems, San Jose, CA Pinnacle Telecommunications, Loomis, CA Meggit Safety Systems, Simi Valley, CA Membranes, Vista, CA Memory System, Scotts Valley, CA West Laboratories, Colorado Springs, CO Logistix, Fremont, CA Luxco, Richmond, CA Luxco, Hayward, CA M & C Specialties, Lancaster, CA M&C Specialties, Southampton, PA M.D. Anderson, Houston, TX Macro Tech. Research, Fremont, CA Manufacturing Corp., Clinton, UT Matsushita Industrial, Tijuana, Mexico medi Manufacturing, Whitsett, NC IML, Campbell, CA Inalfa/SSI Roof Systems, Warren, MI Industrial Molding, Portland, OR Interface Associates, Laguna Niguel, CA International Floratech, AZ Golden Ram, Irvine, CA Grafil, Sacramento, CA H.P, San Jose, CA Henkel Corporation, City of Industry, CA Agilent, San Jose G G Industries, Valencia, CA GE Silicon, Los Angeles, CA General Fabrication, Santa Clara, CA International Manufacturing, CA Isola, Fremont, CA IT Technologies, Vienna, CA Iwata Bolt USA, Garden Grove, CA Jent, Santa Rosa, CA JWP, Santa Clara, CA Kem, Irwindale, CA Kipp Group, Ontario, CA Kira, Lemoore, CA Knape & Vogt, Reno, Nevada Leuze Lumiflex, New Hudson, MI Harmon Calibration, Aldi Inc. Megawatt Defense System G & L Precision Die Cutting, San Jose, CA Eureka Seeds, Woodland, CA Excell USA, Vincennes, IN West Coast Polymers-Los Alamitos, CA Force Corporation, San Jose, CA Freetech Plastics, Milpitas, CA Fritz Companies, San Francisco, CA Emulex, Costa Mesa, CA VT, Phoenix, AZ Escort Memory System, Scotts Valley, CA Derlein Scale, Cedar Rapids, IA VMC, San Diego, CA Devoe Coating, Los Angeles, CA Midwest Towers Inc. Beetle Plastics MAHLE Engine Components Lofthouse Cookies Cable Technology Inc. Balchem Corp US Nutraceuticals Grand Traverse Machine Central Coast Seafood A & D Metal, Inc. Indyne Fluortek Inc. Lund International Sloan Transportation GPS Source Magnolia Beef Company GF Health Products Inc. Northrop Grumman Reliable Hose Service SPX Filtran A3 Tech Inc. Emerson General Dynamics Matrix Machine and Repair PT Artha Karya Utama Shape Medical Systems, Inc. MedRx, Inc. Bertech-Kelex Titan Consulting Aristo-Cote Inc. VAM Drilling USA Inc. Sasol/ GPC CESI Chemical Econolite Telco Tools, Inc. Nicholas Plastics Delta Group Electronics Power & Telephone Supply McFerron Tool & Machine Elliot Company ILF Consulting Engineers Sears Global Technology FedEx Abbott Lab Wesley Medical Center Bank of America USDA Bovis Lend Lease Andrews Trucking US Navy Alaska Meterology Canbera SGS Minerals US Coast Guard Philips Francis Communication Musashi Auto Parts FMC Alcor PetroLab LLP JP Morgan Chase Valley Steel Stamp Diagnostic Automation, Calabasas, CA Quality Plus, Camarillo, CA
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Online Training Links
ISO 9001:2000 Internal Auditing/Auditor and
Implementation
ISO 9001:2008: Introduction & Awareness for
meeting ISO 9001 requirements
ISO 9001:2008: Executive and Management Review
for meeting ISO 9001:2008 requirements
ISO 9001:2008 Internal Auditor and
Implementation
ISO 9001:2000 Capacitación del Auditor Interno
in Spanish
ISO 9001:2000: Executive and Management Review
for meeting ISO 9001:2000 requirements
ISO 9001:2000: Introduction & Awareness for
meeting ISO 9001 requirements
AS 9100 Rev C: Introduction & Awareness for
meeting AS 9100 requirements
AS 9100 Rev B: Executive and Management Review
for meeting AS 9100 requirements
AS 9100 Rev B: Introduction & Awareness for
meeting AS 9100 requirements
ISO 13485 Internal Auditing/Auditor and
Implementation in Chinese
ISO 13485: Internal Auditing /Auditor and
Implementation
ISO 13485 Executive Management Review meeting
ISO 13485
ISO 13485: Introduction & Awareness for meeting
ISO 13485 requirements
ISO 14001 Internal Auditing/Auditor
Implementation in Chinese
ISO 14001:2004 Internal Auditing/Auditor and
Implementation
Aspect, Significant Impact Process/Calculation
Method for meeting ISO 14001
Environmental, Health and Safety Training for
meeting DOT, ISO 14001, OSHA, OSHA 18001,.........
ISO 14001:2004 Executive Review & Management
Review for meeting ISO14001
ISO 14001:2004 Introduction & Awareness for
meeting ISO 14001 requirements
RISK Management Employee Overview for Medical
Device meeting ISO 14971/ISO 13485/FDA/CE MARK
ISO 14971 Risk Management Implementation &
Auditing/Auditor meeting FDA /ISO13485/CE Marking
ISO/TS 16949 INTERNAL AUDITING/AUDITOR and
IMPLEMENTATION
ISO/TS 16949: Executive Review & Management
Review for meeting ISO/TS 16949 requirements
ISO/TS 16949 Introduction & Awareness for
meeting ISO/TS 16949 requirements
ISO 17025 Internal Auditing/ Auditor and
Implementation Training
ISO 17025 Introduction and Employee Overview
ISO 17025 Executive Management Overview
OHSAS 18001: Introduction and Employee Overview
Safety Risk Assessment, Calculation Method,
Hazard Identification, and Risk Control for OSHA 18001
OHSAS 18001: Executive & Management Overview OHSAS 18001: Internal Auditing/Auditor and Implementation
FDA/CGMP Medical Devices Executive Overview &
Management Review for meeting FDA requirements Chinese
FDA/CGMP Medical Devices Executive Overview &
Management Review for meeting FDA requirements
FDA/CGMP Medical Devices Introduction &
Employee Overview in Spanish
FDA/CGMP Medical Devices Introduction &
Employee Overview in Chinese
HACCP Introduction & Employee Overview
FDA/CGMP Medical Devices Introduction &
Employee Overview
Quality Improvement Concepts -continuous
improvements-problem solving and customer satisfaction
FDA/CGMP for Medical Devices, Auditing/
Auditor/Implementation in Spanish
FDA/CGMP for Medical Devices, Auditing/
Auditor/Implementation in Chinese
HACCP Audting and Implementation in Chinese
Business Continuity/Contingency Planning
Implementation and Auditing/Auditor
Injury and Illness Prevention Plan
Implementation and Auditing/Auditor
Storm Water Pollution Prevention Implementation
& Auditing/Auditor
Respiratory Planning - Implementation and
Auditing/Auditor
Lockout/Tagout Plan - Implementation and
Auditing /Auditor
FMEA, Risk Analysis for Medical Devices
FMEA, Potential Failure Mode Effect Analysis
HACCP Seafood - Implementation &
Auditing/Auditor
FDA/CGMP Food - Implementation & Audit/Auditor
FDA/CGMP Blood - Implementation & Audit/Auditor
HACCP Implementation and Auditing/Auditor
FDA/CGMP for Medical Devices, Auditing/
Auditor/Implementation
ESD Overview, Implementation and Auditing
/Auditor
8 D Problem Solving Methodology, Corrective
Action, and Good Business Practices
FDA-GMP Good Laboratory Practice for
nonclinical (21 CFR part58) Implementation and Auditing.
FDA/CGMP Drug (Pharmaceutical) - Implementation
and Audit/Auditor (21CFR210-211)
CE Marking (90/385) for Active Implantable
Medical Devices- Essential Requirements Only CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing CE Marking (93/42 ECC) for medical devices- Essential Requirements only CE Marking (93/42 ECC) for medical devices- Implementation and Auditing CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only |
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