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Developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations.
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficie

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

 

  • One Dial-in One Attendee

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    USD 229
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  • Group-Max 10 Attendees or Location

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    USD 599
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  • 1x Person - Unlimited viewing for 6 Months

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    USD 299
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  • One CD or USB is for usage in one location only

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    USD 399
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  • LIVE + RECORDED VERSION

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    USD 399
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  • LIVE + TRAINING CD or USB

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    USD 499
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About The Event

 

Developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning.