A complete overview in two days. We start with 10CFR50 and 10CFR21, then move on to supply chain qualification and NQA-1 implementation. Safety classification, the 18 elements of NQA-1, qualification of inspection and test personnel, lead auditors, design verification, computer programs, commercial grade dedication and ASME's NQA-1 certificate are explained in detail. Several examples and workshops and are included to provide for easier implementation.
The course offers participants from the fields of quality assurance, project management, manufacturing, sales, purchasing and customer service both the necessary basics and sound guidance for implementation .
The seminar language is English.
Key points of the seminar:
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Basics of Quality Assurance
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10CFR50 Legal basis in the USA, 10CFR21 Deviations
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Supplier approval, safety classification
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The 18 elements of NQA-1
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NQA-1 editions and amendments, ISO 9000 and NQA-1
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Supplier approval, who needs to be audited?
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Survey and audit - is there a difference?
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Inspection and test personnel, auditor and lead auditor
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Indoctrination and training is there a difference?
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What are Activities Affecting Quality?
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Design verification
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Computer programs, verification and validation
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Supplier evaluation and qualification
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Dedication of Commercial Grade Items
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Supplier audits and Approved Vendors List
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Inspection status, tests
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Measuring and test equipment and its calibration
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Handling, packaging and shipping
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Internal audits, audit reports, nonconformities, corrective action
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Documents, Records and archives
