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Risk Assessment - Compliance Using Easy To Fill Out Documentation  

Course "Efficient Risk Assessment - Compliance Using Easy To Fill Out Documentation" has been pre-approved by RAPS as

 

eligible for up to 1.25 credits towards a participant's RAC recertification upon full completion.

Date & Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: David Nettleton

Location: Online

Price : $245.00

David Nettleton FDA Compliance Specialist,

(for one participant)

Overview: This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project. It includes a workshop for participants to perform their own hazard analysis so they are proficient in applying the riskbased techniques.  

Areas Covered in the Session:

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Instructor Profile:

Wednesday, June 20, 2012

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Interactive real life examples. How to identify risk and establish mitigations. How to use the hazard analysis to make validation efficient. How to document the risk assessment using a template How risk assessment reduces validation time. Determine risk in a process to reduce the testing effort. Traceability made automatic Workshop exercises.

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David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects....more

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IT QA

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QC Laboratory staff Managers

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GMP, GCP, GLP professionals

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Risk Assessment - Compliance Using Easy To Fill Out Documentation