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Part3: Introduction to Risk Based Qualification &rdan

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A. Functional areas Risk Assessment Survey yo
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B. Benefits of Based Risk Qualification .M
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C. Principles for Risk‐Based 1Qualification E
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E.Risk Based Qualification in g & Validation
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A. Functional areas Risk Assessment Survey rd
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2006 Parenteral Drug Association survey on the functional area that has the most need for Risk Assessment
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B. Benefits of Based Risk Qualification (1/4) rd
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B. Benefits of Based Risk Qualification (3/4) rd
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B. Benefits of Based Risk Qualification (4/4) rd
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C. Principles for Risk‐Based Qualification an
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Focus on that which affects product quality
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Process User Requirements key to acceptability (IQ/OQ
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Only critical features/functions to be qualified
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D. Introduction about Risk Assessment during cGMP project Lifecycle (1/15) n
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Define : Selected option is developed,
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decision (FID)].
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D. Introduction about Risk Assessment during cGMP project Lifecycle (2/15) n
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D. Introduction about Risk Assessment during cGMP project Lifecycle (3/15) an
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D. Introduction about Risk Assessment during cGMP project Lifecycle (4/15)
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D. Introduction about Risk Assessment during
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D. Introduction about Risk Assessment during
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Agon Academy, Risk-Based Q&V
April. 2018-Eng.Majdi Ayoub 13
D. Introduction about Risk Assessment during
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RA for Design
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April. 2018-Eng.Majdi Ayoub 15
D. Introduction about Risk Assessment during
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D. Introduction about Risk Assessment during
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Leveraging Risk D. Introduction about Risk Assessment during
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D. Introduction about Risk Assessment during cGMP project Lifecycle (11/15) an
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April. 2018-Eng.Majdi Ayoub 21
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Leveraging Risk D. Introduction about Risk Assessment during
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Section D2018:-E to be n g

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Video 11 about Validation
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Video Link : After
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2018-Eng.Majdi Ayoub 24

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