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ComplianceOnline, Online Event
2012-11-13
Why Should You Attend: The trends and reports are showing that FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing proportionally and most organizations are not ready or prepared to host FDA inspections when Part 11 is in scope. Companies are unsure how to best use and implement audit trails and have challenges with internal and external auditing for Part 11 compliance.
This 4-hr session will address all of these topics and provide you with plenty of HOW TOs to increase your comfort level with the regulation, with its elements and compliance, and practically implement audit system and audit trails - especially since audit trails play a major role in Part 11 compliance, they can be your best friends and/or worst enemies at the same time. Areas Covered in the Seminar: - How to prepare and host FDA inspection when Part 11 is in scope.
- Internal and External Auditing for Part 11 Compliance.
- Audit Trails: Ins and Outs.
- Overview and Correlation of Part 11 with other regulations.
- Trends, Warning Letters, Advantages and Disadvantages of Compliance/Use of Part 11.
- Sample Audit Questions.
Event Details: Date: November 13, 2012 Time: 09:00 AM-01:00 PM PDT Cost: $499 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart. |
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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Jasmin NUHIC - Professional with proven record of leading teams that deliver projects in full scope, below a budget and ahead of schedule through process optimization, business growth and talent development. Over 12 years of experience in FDA regulated industry with vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. Positive and verifiable track record in continuous improvement and cost saving initiatives through use of lean sigma and six sigma methodologies.
Salim Khan - holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.
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Deadline for Abstracts:
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2012-11-13
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Registration:
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http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702439?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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