Course Outline for ISO 19011:2002 QMS & EMS Auditor
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1 Course objective Course Outline for ISO 19011:2002 QMS & EMS Auditor The auditor training program is based on ISO 19011:2002, which is a guideline document for auditing and implementing quality systems ISO 19011:2002, and getting the skills necessary to quickly and efficiently audit using the new QMS and EMS auditing guideline to ISO 19011: days are required to complete the ISO course Anyone who wants to quickly and efficiently understand and learn how to audit using the new QMS and EMS auditing guideline to ISO 19011:2002, upgrade your expertise from auditing with ISO to ISO 19011: DEFINITIONS 2. TYPES OF AUDITS 3. AUDIT OBJECTIVES 4. ROLES AND RESPONSIBILITIES 5. AUDITOR ACTIVITIES 6. INITIATING THE AUDIT 7. PREPARING THE AUDIT 8. EXECUTING THE AUDIT 9. WHAT THE AUDITOR IS LOOKING FOR 10. AUDIT DOCUMENTS 11. AUDIT TECHNIQUES: TELL ME/SHOW ME 12. AUDIT TECHNIQUES: AUDIT PATH 13. AUDIT TECHNIQUES: GRADUAL ELEVATION 14. AUDIT TECHNIQUES: SAMPLING 15. AUDIT COMPLETION AND CORRECTIVE ACTION FOLLOW-UP This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. And, we have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements If you are not familiar with the ISO 9000:2000, it is recommended to take the ISO 9000:2000 training course first.
2 The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
3 Course objective Course Outline for ISO 14001:2004 Auditor The auditor training program is based on ISO 14001:2004, which is a guideline document for auditing and implementing quality systems ISO 14001:2004, upgrading expertise from auditing ISO 9000 to ISO 14001:2004 and from auditing to ISO 14001:1996 to ISO 14001:2004, and upgrading expertise from auditing with the guidance ISO to ISO 19011: days are required to complete the ISO auditor course Anyone who wants in-depth understanding of the ISO Audit Process. This is the ideal training course for responsible in charge of planning and scheduling an audit program or must perform audits to ISO 14000: Quality Assurance and Environmental Affairs Managers, Quality Assurance and Environmental Professionals 1. DEFINITIONS 2. TYPES OF AUDITS 3. AUDIT OBJECTIVES 4. ROLES AND RESPONSIBILITIES 5. AUDITOR ACTIVITIES 6. INITIATING THE AUDIT 7. PREPARING THE AUDIT 8. EXECUTING THE AUDIT 9. WHAT THE AUDITOR IS LOOKING FOR 10. AUDIT DOCUMENTS 11. AUDIT TECHNIQUES: TELL ME/SHOW ME 12. AUDIT TECHNIQUES: AUDIT PATH 13. AUDIT TECHNIQUES: GRADUAL ELEVATION 14. AUDIT TECHNIQUES: SAMPLING 16. AUDIT COMPLETION AND CORRECTIVE ACTION FOLLOW-UP 17. ENVIRONMENTAL CASE STUDIES This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. And, we have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide (
4 Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
5 Course Outline for ISO 13485:2003 Training Course objective This course gives an overview of all important aspects for managers of an organization in order to implement and maintain an ISO 9001:2000 compliant management system. 1 day is required to complete the ISO course This is the ideal course for anyone who do NOT have time to allocate a full day to take a LIVE course on ISO 13485:2003, and who wants to quickly and efficiently understand what ISO 13485:2003 and ISO 9001:2000 are about, You want to upgrade your knowledge and expertise from ISO 13485:1996 or ISO 9000:1994, en to ISO 13485:2003. The Standard The Process Approach Scope Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
6 Course objective Course Outline for ISO 13485:2003/ ISO Auditor This course has been specifically designed to meet the needs of the Medical Device Industry and is for individuals responsible for planning and scheduling an audit program for ISO and those who must perform audits to ISO for quality assurance. It provides in-depth understanding of the ISO Audit Process 2 days are required to complete the ISO auditor course This is the ideal course for anyone who wants to quickly and efficiently learn how to audit to ISO 13485:2003, upgrade his/her expertise from auditing ISO 13485:1996 to ISO 13485:2003, and upgrade his/her expertise from auditing with the guidance ISO to ISO 19011:2002, 1. DEFINITIONS 2. TYPES OF AUDITS 3. AUDIT OBJECTIVES 4. ROLES AND RESPONSIBILITIES 5. AUDITOR ACTIVITIES 6. INITIATING THE AUDIT 7. PREPARING THE AUDIT 8. EXECUTING THE AUDIT 9. WHAT THE AUDITOR IS LOOKING FOR 10. AUDIT DOCUMENTS 11. AUDIT TECHNIQUES: TELL ME/SHOW ME 12. AUDIT TECHNIQUES: AUDIT PATH 13. AUDIT TECHNIQUES: GRADUAL ELEVATION 14. AUDIT TECHNIQUES: SAMPLING 18. AUDIT COMPLETION AND CORRECTIVE ACTION FOLLOW-UP 19. MEDICAL DEVICE CASE STUDIES This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide (
7 Course requirements If you are not familiar with the ISO 9000:2000, it is recommended to take the ISO 13485:2003 training course first. The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
8 Course Outline for ISO/TS 16949:2002 Training Course objective This course gives an in-depth understanding of the TS 16949:2002 Audit Process. It has been specifically designed to meet the needs of the Auto Industry. Those responsible for planning and scheduling an audit program for TS 16949:2002 and those who must perform audits to TS 16949:2002 for quality assurance. 1 day is required to complete the ISO/TS 16949:2002 course Anyone who do not have time to allocate a full day to take a LIVE course on ISO/TS 16949:2002, wants to quickly and efficiently understand what ISO/TS 16949:2002 and ISO 9001:2000 are about, and ISO 9001:2000 are about, and wants to upgrade his/her knowledge and expertise from QS 9000 or ISO 9000:1994 to ISO/TS 16949:2002. The Standard The Process Approach Scope Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher
9 Course Outline for ISO/TS 16949:2002/ISO Auditor Course objective This course has been specifically designed to meet the needs of the Auto Industry and those responsible for planning and scheduling an audit program for TS 16949:2002, and those who must perform audits to TS 16949:2002 for quality assurance. This course gives an in-depth understanding of the TS 16949:2002 Audit Process has to take this course. 2 days are required to complete the ISO/TS auditor training course Anyone who do not have time to allocate two full days to take a LIVE course on ISO/TS 16949:2002, wants to quickly and efficiently learn how to audit to ISO/TS 16949, upgrade his/her expertise from auditing QS 9000 to ISO/TS and from auditing with the guidance ISO to ISO 19011: DEFINITIONS 2. TYPES OF AUDITS 3. AUDIT OBJECTIVES 4. ROLES AND RESPONSIBILITIES 5. AUDITOR ACTIVITIES 6. INITIATING THE AUDIT 7. PREPARING THE AUDIT 8. EXECUTING THE AUDIT 9. WHAT THE AUDITOR IS LOOKING FOR 10. AUDIT DOCUMENTS 11. AUDIT TECHNIQUES: TELL ME/SHOW ME 12. AUDIT TECHNIQUES: AUDIT PATH 13. AUDIT TECHNIQUES: GRADUAL ELEVATION 14. AUDIT TECHNIQUES: SAMPLING 15. AUDIT COMPLETION AND CORRECTIVE ACTION FOLLOW-UP 16. AUTOMOTIVE INDUSTRY CASE STUDIES This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements
10 If you are not familiar with the ISO 9000:2000, it is recommended to take the ISO/TS 16949:2002 training course first. The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
11 Course Outline for FDA-cGMP Medical Devices Training Quality System Requirements -21CFR820 Course objective It has been specifically designed to meet the needs of people involved in current good manufacturing practices for medical devices. This course gives an in-depth understanding of the FDA and European cgmp requirements. It is helpful in understanding the legal requirements and regulatory expectations relating to CGMP, as well as the costs of non-compliance. 1 day is required to complete the Quality System Requirements -21CFR820 course. Anyone who does not have time to allocate a full day to take a LIVE course on the cgmp Quality System Requirements (QSR), wants to quickly and efficiently understand what the FDA's GMP for medical devices is about, and implement the GMP without using a consulting firm PART 820--QUALITY SYSTEM REGULATION Subpart A General Provisions Subpart B Quality System Requirements Subpart C Design Controls Subpart D Document Controls Subpart E Purchasing Controls Subpart F Identification and Traceability Subpart G Production and Process Controls Subpart H Acceptance Activities Subpart I Nonconforming Product Subpart J Corrective and Preventive Action Subpart K Labeling and Packaging Control Subpart L Handling, Storage, Distribution, and Installation Subpart M Records
12 Subpart N Servicing Subpart O Statistical Techniques This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
13 Course Outline for FDA-cGMP Food Industry Training Course objective This training course has been designed for individuals involved in the food industry. It offers an introduction to food security for state and local sanitarians, USDA FSIS field inspectors, and HHS FDA field inspectors. 1 day is required to complete this cgmp course Anyone who do not have time to allocate a full day to take a LIVE course on the cgmp and 21CFR110, wants to quickly and efficiently understand what the FDA's GMP for human food manufacturers is about, and implement the GMP without using a consulting firm Subpart A--General Provisions Definitions Current good manufacturing practice Personnel Exclusions. Subpart B--Buildings and Facilities Plant and grounds Sanitary operations Sanitary facilities and controls. Subpart C--Equipment Equipment and utensils Subpart D [Reserved] Subpart E--Production and Process Controls Processes and controls Warehousing and distribution. Subpart F [Reserved] Subpart G--Defect Action Levels Natural or unavoidable defects in food for human use that present no health hazard. PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
14 This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
15 Course Outline for FDA-cGMP for Finished Pharmaceuticals Training 21CFR Course objective This training course has been designed for individuals involved in pharmaceutical industry. It offers to understand what the FDA's GMP for finished pharmaceuticals is about. 1-2 days are required to complete the FDA's GMP for finished pharmaceuticals course. Anyone who do not have time to allocate a full day to take a LIVE course on FDA's GMP for finished pharmaceuticals, wants to quickly and efficiently understand what the pharmaceutical FDA's GMP requirements are, and implement the GMP without using a consulting firm Sec Definitions Part Current good manufacturing practice for finished pharmaceuticals Subpart A--General Provisions Subpart B--Organization and Personnel Subpart C--Buildings and Facilities Subpart D--Equipment Subpart E--Control of Components and Drug Product Containers and Closures Subpart F--Production and Process Controls Subpart G--Packaging and Labeling Control Subpart H--Holding and Distribution Subpart J--Records and Reports Subpart K--Returned and Salvaged Drug Products This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide (
16 Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.
17 Course Outline for FDA-GLP Good Laboratory Practices Training 21CFR58 Course objective This training course has been designed for individuals involved in Laboratories and Testing Facilities. It provides training on the FDA's Good Laboratory Practice for nonclinical Laboratory Studies. 1 day is required to complete the GLP course. Anyone who do not have time to allocate a full day to take a LIVE course on FDA's GLPs, wants to quickly and efficiently understand what the regulation and requirements are, and implement the GLP without using a costly training or consulting firm. CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES 58.1 Scope Definitions Applicability to studies performed under grants and contracts Inspection of a testing facility Personnel Testing facility management Study director Quality assurance unit General Animal care facilities Animal supply facilities Facilities for handling test and control articles Laboratory operation areas Specimen and data storage facilities Equipment design Maintenance and calibration of equipment Standard operating procedures Reagents and solutions Animal care Test and control article characterization.
18 Test and control article handling Mixtures of articles with carriers Protocol Conduct of a nonclinical laboratory study Reporting of nonclinical laboratory study results Storage and retrieval of records and data Retention of records Purpose Grounds for disqualification Notice of and opportunity for hearing on proposed disqualification Final order on disqualification Actions upon disqualification Public disclosure of information regarding disqualification Alternative or additional actions to disqualification Suspension or termination of a testing facility by a sponsor Reinstatement of a disqualified testing facility. This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide ( Course requirements The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher
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