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Master list of training

  • Medical Devices Executive Overview--Management Review meeting FDA/CGMP requirement Spanish (CEU 0.4)
  • FDA/CGMP Medical Devices Executive Overview-Management Review for meeting FDA req Chinese (CEU 0.4)
  • FDA/CGMP Medical Devices Introduction & Employee Overview in Spanish (CEU 0.4)
  • FDA/CGMP Medical Devices Introduction & Employee Overview in Chinese (CEU 0.4)
  • HACCP Introduction & Employee Overview (CEU 0.4)
  • FDA/CGMP Medical Devices Introduction & Employee Overview (CEU 0.4)
  • Quality Improvement Concepts -cont. improvements-problem solving and customer satisfaction (CEU 0.4)
  • FMEA, Risk Analysis for Medical Devices (CEU 0.4)
  • FMEA, Potential Failure Mode Effect Analysis (CEU 0.4)
  • ESD EMPLOYEE AWARENESS (CEU 0.4)
  • FDA/CGMP Medical Devices Executive Overview & Mgmt. Review for meeting FDA requirements (CEU 1.6)
  • FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation in Spanish (CEU 1.6)
  • FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation in Chinese (CEU 1.6)
  • HACCP Audting and Implementation in Chinese (CEU 1.6)
  • Business Continuity/Contingency Planning Implementation and Auditing/Auditor (CEU 1.6)
  • Injury and Illness Prevention Plan Implementation and Auditing/Auditor (CEU 1.6)
  • Storm Water Pollution Prevention Implementation & Auditing/Auditor (CEU 1.6)
  • Respiratory Planning - Implementation and Auditing/Auditor (CEU 1.6)
  • Lockout/Tagout Plan - Implementation and Auditing /Auditor (CEU 1.6)
  • HACCP Seafood - Implementation & Auditing/Auditor (CEU 1.6)
  • FDA/CGMP Food - Implementation & Audit/Auditor (CEU 1.6)
  • FDA/CGMP Blood - Implementation & Audit/Auditor (CEU 1.6)
  • HACCP Implementation and Auditing/Auditor (CEU 1.6)
  • FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation (CEU 1.6)
  • ESD Overview, Implementation and Auditing /Auditor (CEU 1.6)
  • 8 D Problem Solving Methodology, Corrective Action, and Good Business Practices (CEU 0.4)
  • FDA-GMP Good Lab Practice for nonclinical (21 CFR part58) Implementation and Auditing (CEU 1.6)
  • FDA/CGMP Drug (Pharmaceutical) - Implementation and Audit/Auditor (21CFR210-211) (CEU 1.6)
  • CE Marking (90/385) for Active Implantable Medical Devices- Essential Requirements Only (CEU 0.4)
  • CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing (CEU 1.6)
  • CE Marking (93/42 ECC) for medical devices- Essential Requirements only (CEU 0.4)
  • CE Marking (93/42 ECC) for medical devices- Implementation and Auditing (CEU 1.6)
  • CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only (CEU 1.6)
  • CE Marking IVD 98-79 EEC Implementation and Auditing (CEU 1.6)
  • Dietary Supplements: Overview Based on FDA Guidance 2002 (CEU 0.4)
  • TL 9000: Internal Auditing (CEU 1.6)
  • ISO 9001:2000 Internal Auditing/Auditor and Implementation (CEU 1.6)
  • ISO 9001:2008: Introduction & Awareness for meeting ISO 9001 requirements (CEU 0.4)
  • ISO 9001:2008: Executive and Management Review for meeting ISO 9001:2008 requirements (CEU 0.4)
  • ISO 9001:2008 Internal Auditor and Implementation (CEU 1.6)
  • ISO 9001 Executive and Management Review for meeting ISO 9001 in Spanish (CEU 0.4)
  • ISO9001 Introduction and Awareness for meeting ISO 9001 in Spanish (CEU 0.4)
  • ISO 9001 Capacitación del Auditor Interno in Spanish (CEU 1.6)
  • ISO 9001:2000: Executive and Management Review for meeting ISO 9001:2000 requirements (CEU 0.4)
  • ISO 9001:2000: Introduction & Awareness for meeting ISO 9001 requirements (CEU 0.4)
  • AS 9100 Rev B Internal Auditing/Auditor and Implementation (CEU 1.6)
  • AS 9100 Rev C: Executive and Management Review for meeting AS 9100 requirements (CEU 0.4)
  • AS 9100 Rev C: Introduction & Awareness for meeting AS 9100 requirements (CEU 0.4)
  • AS9100 Rev C Internal Auditor and Implementation (CEU 1.6)
  • AS 9100 Rev B: Executive and Management Review for meeting AS 9100 requirements (CEU 0.4)
  • AS 9100 Rev B: Introduction & Awareness for meeting AS 9100 requirements (CEU 0.4)
  • ISO 13485 Internal Auditing/Auditor and Implementation in Chinese (CEU 1.6)
  • ISO 13485: Internal Auditing /Auditor and Implementation (CEU 1.6)
  • ISO 13485 Executive Management Review meeting ISO 13485 (CEU 0.4)
  • ISO 13485: Introduction & Awareness for meeting ISO 13485 requirements (CEU 0.4)
  • ISO 14001 Internal Auditing/Auditor Implementation in Chinese (CEU 1.6)
  • ISO 14001:2004 Internal Auditing/Auditor and Implementation (CEU 1.6)
  • Aspect, Significant Impact Process/Calculation Method for meeting ISO 14001 (CEU 0.4)
  • Environmental, Health and Safety Training for meeting DOT, ISO 14001, OSHA, OSHA 18001,... (CEU 1.6)
  • ISO 14001:2004 Executive Review & Management Review for meeting ISO14001 (CEU 0.4)
  • ISO 14001:2004 Introduction & Awareness for meeting ISO 14001 requirements (CEU 0.4)
  • RISK Mgmt Employee Overview for Medical Device meeting ISO 14971/ISO 13485/FDA/CE MARK (CEU 0.4)
  • ISO 14971 Risk Mgmt. Implementation & Auditing/Auditor meeting FDA /ISO13485/CE Marking (CEU 1.6)
  • ISO/TS 16949 INTERNAL AUDITING/AUDITOR and IMPLEMENTATION (CEU 1.6)
  • ISO/TS 16949: Executive Review & Management Review for meeting ISO/TS 16949 requirements (CEU 0.4)
  • ISO/TS 16949 Introduction & Awareness for meeting ISO/TS 16949 requirements (CEU 0.4)
  • ISO 17025 Internal Auditing/ Auditor and Implementation Training (CEU 1.6)
  • ISO 17025 Introduction and Employee Overview (CEU 0.4)
  • ISO 17025 Executive Management Overview (CEU 0.4)
  • OHSAS 18001: Introduction and Employee Overview (CEU 0.4)
  • Safety Risk Assessment, Calculation Method, Hazard ID, and Risk Control for OSHA 18001 (CEU 0.6)
  • >- Hazard Management Training for Meeting DOT, OSHA, OSHA 18001, ISO 14001, HACCP... (CEU 0.6)
  • Hazard Communication Training for meeting DOT, OSHA, OSHA 18001, ISO 14001, HACCP.. (CEU 0.6)
  • OHSAS 18001: Executive & Management Overview (CEU 0.4)
  • OHSAS 18001: Internal Auditing/Auditor and Implementation (CEU 1.6)
  • ISO 20000 (Info tech: Service management): Internal Auditing/Auditor and Implementation (CEU 1.6)
  • ISO 22000 Food Safety Mgmt. Systems: Internal Auditor/Auditing training and implement (CEU 1.6)
  • ISO 27001 Information Security Management: Internal Auditing Training and Implementation (CEU 1.6)
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    Course Details

    Course# QU6013a
    Course Desc FDA/CGMP Drug (Pharmaceutical) - Implementation and Audit/Auditor (21CFR210-211) (CEU 1.6)
    Your Price $163.00

    Course Overview

    Definitions
    What are the CGMP requirements?
    What are the Responsibilities of Quality Control Unit requirements?
    What are the Personnel Qualifications requirements?
    What are the Personnel Responsibilities requirements?
    What are the Consultants requirements?
    Audit Questions
    What are the Design and Construction Features requirements?
    What are the Lighting requirements?
    What are the Ventilation, Air Filtration, Air Heating and Cooling requirements?
    What are the Plumbing requirements?
    What are the Sewage and Refuse requirements?
    What are the Washing and Toilet Facilities requirements?
    What are the Sanitation requirements?
    What are the Maintenance requirements?
    Audit Questions
    What are the Equipment Design, Size, and Location requirements?
    What are the Equipment Construction requirements?
    What are the Equipment Cleaning and Maintenance requirements?
    What are the Automatic, Mechanical, and Electronic Equipment requirements?
    What are the Filters requirements?
    Audit Questions
    What are the General Requirements for Control of Components and Product Containers and Closures?
    What are the Receipt and Storage of Untested Components, Containers and Closures requirements?
    What are the Testing and Approval or Rejection of Components, Containers and Closures requirements?
    What are the Use of Approved Components, Drug Product Containers and Closures requirements?
    What are the Retesting of Approved Components, Product Containers and Closures requirements?
    What are the Rejected Components, Drug Product Containers, and Closures requirements?
    What are the Drug Product Containers and Closures requirements?
    Audit Questions
    What are the Written Procedures and Deviations requirements?
    What are the ChargeIn of Components requirements?
    What are the Calculation of Yield requirements?
    What are the Equipment Identification requirements?
    What are the Sampling and Testing of InProcess Materials and Drug Products requirements?
    What are the Time Limitations on Production requirements?
    What are the Control of Microbiological Contamination requirements?
    What are the Reprocessing requirements?
    Audit Questions
    What are the Materials Examination and Usage Criteria requirements?
    What are the Labeling Issuance requirements?
    What are the Packaging and Labeling Operations requirements?
    What are the TamperEvident Packaging Requirements for OTC Human Drug Products?
    What are the Drug Product Inspection requirements?
    What are the Expiration Dating requirements?
    Audit Questions
    What are the Warehousing Procedures requirements?
    What are the Distribution Procedures requirements?
    Audit Questions
    What are the General Requirements for Laboratory Controls?
    What are the Testing and Release for Distribution requirements?
    What are the Stability Testing requirements?
    What are the Special Testing Requirements?
    What are the Reserve Samples requirements?
    What are the Laboratory Animals requirements?
    FDA/CGMP Exam
    Certificate available upon passing test


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