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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 -
www.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.
Business Sectors & Industries Supported: IAF Codes
1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,
17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,
35,36,37,38,40
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Online training, consulting
and certification for all U.S. states and worldwide including Aruba, Puerto
Rico, US Virgin Islands and Caribbean Islands.
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California)
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California)
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California)
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California)
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California)
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Consulting, Training,
development, verification, certification, auditing, translation services,
for the following:
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Software Verification and
Validation
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FDA QSR/GMP, ISO 13485 Audit
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DA QSR/GMP, ISO 13485
Implementation Assistance
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Design Control Compliance
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Risk Assessment/Hazard Analysis
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510(k)
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PMA
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IDE
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CE Mark
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Electronic Recordkeeping
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IEC 60601 Compliance
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FDA Submissions: 510(k) IDE, PMA,
Product Reports
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Software Quality Compliance
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Medical Device License Submissions
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FDA 483 & Warning Letter (response
& resolution support)
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CGMP Compliance
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FDA Registration
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Agent for Non-USA Firms
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Medical Device Reporting (MDR)
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Post Market Surveillance
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CE Marking European MDD 90/385/EEC
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CE Marking European MDD 93/42/EEC
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CE Marking European MDD 98/79/EEC
Consulting and Training services
for meeting FDA, CGMP, HACCP, ISO 22000, and other standards:
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HACCP
(General)
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Seafood HACCP
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Dairy HACCP
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Juice HACCP
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Retail HACCP
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Meat HACCP
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Poultry HACCP
We provide consulting and
training services in partnership with ISO Accelerate and Quality University
Consulting and training services
for meeting OSHA Regulations, FDA, CGMP, OSHA 18001, ISO 14001, OSHA 13485,
AS 9100, HACCP, ISO 22000, and other standards:
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Bloodborne Pathogens
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Hazard Communications
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Hazardous Materials Transportation
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Material Safety Data Sheets
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Office Ergonomics
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US DOT Hazardous Materials
Transportation Training
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Lockout Tagout (OSHA)
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Hazard Communications
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Personal Protective Equipment
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Forklift
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Injury and Illness Prevention
Program
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Emergency Response and Fire Safety
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Biosafety and Bloodborne Pathogens
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Hazcom and chemical safety
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Chemical Waste Management
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Basic Safety Orientation Training
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Emergency First Aid and CPR
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Chemical Spills
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Confined Space Entry
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Emergency Response Course Modules
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Entrenamiento Para Montacargistas-Forklift
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Environmental Health Risk
Assessments
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Lockout Tagout in Spanish
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Lockout Tagout Verify Awareness
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Hazardous communication Training
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Hazardous Materials Management
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Intro to Forklift Safety
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OSHA Hazard Communications
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OSHA's New Ergonomics Standard 29
CFR 1910.900
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Risk Management
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The Hazardous Matreial Regulation
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Workplace Ergonomics
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Workplace Hazard Management
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Identification, evaluation, and
analysis of significant aspects for meeting ISO 14000 needs.
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Contingency Planning
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Risk Assessment using FME Approach
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Risk Assessment/Hazard Analysis
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HAZMAT Internal Audits
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CGMP Audits
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Supplier Audits
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Regulatory Compliance Audits
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ONLINE TRAINING
Select training below:
                                               
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Countries supported for
Certification, Training and Consulting
USA,
Albania, Algeria, Andorra, Antigua and Barbuda, Argentina,
Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados,
Belarus, Belgium, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina,
Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon,
Canada, Cape Verde, Central African Republic, Chad, Libya, Liechtenstein,
Lithuania, Luxembourg, Macedonia, Former Yugoslav Republic of, Madagascar,
Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania,
Mauritius, Mexico, Micronesia, Federated States of, Moldova, Monaco, Mongolia,
Montenegro, Morocco, Mozambique, Myanmar (Burma), Namibia, Nauru, Nepal,
Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman,
Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland,
Portugal, Qatar, Romania, Russia, Rwanda, Saint Kitts and Nevis, Saint Lucia,
Saint Vincent and The Grenadines, Samoa, San Marino, Sao Tome and Principe,
Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia,
Slovenia, Solomon Islands, Somalia, South Africa, Spain, Sri Lanka, Sudan,
Suriname, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania,
Thailand, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan,
Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States,
Uruguay, Uzbekistan, Vanuatu, Vatican City, Venezuela, Vietnam, Western Sahara,
Yemen, Zambia, Zimbabwe, Chile, China, Colombia, Comoros, Congo (Brazzaville),
Congo Democratic Republic of the, Costa Rica, Côte d'Ivoire, Croatia, Cuba,
Cyprus Czech Republic, Denmark Djibouti, Dominica, Dominican Republic, East
Timor (Timor Timur), Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea,
Estonia, Ethiopia, Fiji, Finland, France, Gabon, Gambia The, Georgia, Germany,
Ghana, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti,
Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica,
Japan, Jordan, Kazakhstan, Kenya, Kiribati, Korea South, Kuwait, Kyrgyzstan,
Laos, Latvia, Lebanon, Lesotho, and Liberia |
