PTI - international

Achieving Regulatory and Business Success

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Complying with 21 CFR Part 11

How to Develop and Implement Risk-Based Strategies

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

Agenda: Day Two

VI. Ensure Data Security and Integrity

VII. Execute Electronic Signatures

VIII. Perform Part 11 Assessment and Remediation Planning  

IX. Manage Electronic Documents/Records and Compile e-Submissions

X. Prepare for FDA Inspection

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

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