| Who Should Attend: |
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Individuals who are responsible for developing an internal quality audit process and or
performing audits. This seminar is geared to individuals who have a basic understanding
of ISO 9000 or the FDA Quality System Regulation and have limited experience with internal
auditing.
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| Locations: |
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Chicago: November 26, 2001 (Monday during RSNA) Location TBD.
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| Course Hours: |
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From 9:00 a.m. - 4:30 p.m. Your instructor is also available during lunch for
informal discussions about your specific area of interest.
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| Course Tuition: |
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The course tuition is $395 for one days. It includes class participation, handouts of
the slides (the ones that are not copyright protected), breakfast, morning and afternoon
refreshments and a lunch.
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| Payment Method: |
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Payment can be made by Check or AMEX-VISA/MasterCard, or with a PO. 10% Multiple
enrollment discount will be offered when two or more people from the same organization
enroll together for the same location.
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| Seminar Content: |
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This course includes an analysis of the 20 Elements of the ISO 9001:1994 Standard,
FDA Quality System Regulation and shows you how to plan, conduct, and report internal
quality audits to meet FDA and ISO regulations. The training will be presented in 3 parts.
Part 1 will cover:
- The qualities that make a good auditor
- The skills that need to be developed by the auditor
- Auditor Preparation and Planning of Internal Audits
- What the Standards require of the Internal
- Purpose and Benefits of International Quality Audits
- Corrective Actions
- Audit Records
- Review of Audits
- Management Responsibilities
- An introduction to the human aspects of auditing
Part 2 will cover the Quality System Regulations:
- Understanding and interpretation of the quality system elements
- What documents and records should be available
- What to look for and how to conduct the actual audit.
Part 3 will review approximately 200 test questions to verify you have a complete
understanding of Audit Planning, Administration, Implementation, Reporting, etc.
By the end of the session you will have learned the requirements of the FDA Quality
System Regulation, ISO 9001:1994 and practiced the skills
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