Implementing a Risk-Based Approach to Part 11 Compliance
Training Overview
Improve your ability to:
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Determine when Part 11 does or does not apply to electronic data and documents
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Identify and comply with "in force" Part 11 requirements
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Identify and comply with predicate rule requirements related to computerized systems and electronic records
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Apply risk analysis techniques to assess level of controls necessary for individual computer and software systems
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Implement Part 11 controls as appropriate
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Validate computer and software systems, including commercial off-the-shelf (COTS) systems
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Develop remediation plans to achieve and maintain compliance
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Anticipate FDA inspectors' expectations for Part 11
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-03-014-L04. Initial release: 03/2003.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.