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GlobalCompliancePanel, Online Training Webinar
2010-11-02
This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: - Which data and systems are subject to Part 11.
- What Part 11 means to you, not just what it says in the regulation.
- Avoid 483 and Warning Letters.
- Explore 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.
- SOPs required for the IT infrastructure.
- Product features to look for when purchasing COTS software.
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
Who Will Benefit: - IT
- QA
- QC
- Laboratory staff
- Managers
- GMP, GCP, GLP professionals
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2010-11-01
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Registration:
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| | Live live online training only for one participant | | |
| | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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