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2-day In-person Seminar on “Software Validation for the New FDA Inspections” in San Diego

Course "Software Validation for the New FDA Inspections" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

19 20 September 2013

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Computer systems need to be compliant in relation to a few important areas. Some areas of regulation relating to implementation of computerized systems can be worked out for better results.When more enhanced and effective software validation systems are put in place, an organization can save hugely on resources and time.

Helping participating organizations achieve all these is the aim of this seminar. It will help participants reduce software validation costs by as much as two thirds. During two days of high interaction studded with real life examples and proven techniques; the speaker, David Nettleton will bring the full strength of his experience in the field and detail all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.

Participants will learn how to use electronic records and electronic signatures to maximize productivity. They will also be able to prepare for an audit and will benefit IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.

A grasp of advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation and reducing testing time, and preparing documents that avoid 483s and warningare the other benefits of this seminar.

1 speaker

2 sessions

Thursday Day 1 from 9am to 6pm Thursday 19th September 2013

Friday Day 2 from 9am to 6pm Friday 20th September 2013

2 known attendees

  • GlobalCompliancePanel
  • David Nettleton

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