ComplianceOnline, Online Event
2012-11-15
Why Should You Attend: Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency - both efficiency in project management, and avoidance of non-compliance penalties.
This 90-minute session will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements. Areas Covered in the Seminar: - History and Overview.
- Subpart A: General Provisions.
- Subpart B: Electronic Records.
- Subpart C: Electronic Signatures.
- Scope & Application Guidance.
- Questions and Answers.
Event Details: Date: November 15, 2012 Time: 10:00 AM-11:30 AM PDT Cost: $249 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart.
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Invited Speakers:
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Harry Huss, has over 30 years of experience in the pharmaceutical/medical industry. He is currently Chief Compliance Officer, Touchstone Technologies Silicon Valley; and has held positions as Executive Directive, Brandywine Compliance Consulting; Senior Director Compliance Policy & Program Support Services, Charles River Laboratories; Associate Director of Computer Validation Quality Assurance, Merck & Company; and Regulatory Compliance Manager, SmithKline Beecham.
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