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RAPS Approved Webinar  


21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits  

Date & Time: Course "21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits" has been pre-approved by



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RAPS as eligible for up to 1.25 credits towards a participant's RAC recertification upon full completion. Instructor Profile: Tuesday, October 2, 2012

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)

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

Overview: This webinar details both regulations and provides details for implementing computerized systems. Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures to greatly increase productivity.

Why should you attend: This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The training will be discussing the

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recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.

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Which data and systems are subject to the regulations? What the regulations mean, not just what they say. Avoid 483 and Warning Letters. Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation. Ensure data integrity, security, and protect intellectual property. Understand the current computer system industry standards for security, data transfer, and audit trails. Electronic signatures, digital pens, and biometric signatures. Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures. SOPs required for the IT infrastructure. Product features to look for when purchasing COTS software. Reduce validation resources by using easy to understand fillin-the-blank validation documents.

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21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits