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GlobalCompliancePanel, San Francisco,CA,USA
2012-07-26
Overview: In this two day seminar you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance helping you to avoid 483s. Using the risk based computer system validation approach you will validate your own Excel application. Use of the validation templates typically saves two thirds of the validation time and costs.
This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application validation projects.
Course Outline: Day 1:- Introductions
- Regulations for Electronic Records
- 21 CFR Part 11 - Electronic Records & Signatures
- The Risk-Based Validation Approach
- Excel Applications - part 1
- Create a User Requirements document for your application
- Create a Project Plan document for your application
- Create a Functional Specifications document for your application
Day 2:- How to Conduct a Hazard Analysis/Risk Assessment
- Excel Applications - part 2
- Create a Hazard Analysis document for your application
- Create a Testing Protocol document for your application
- Main Concepts to Remember
- Q&A
Areas Covered in the Session:- Develop spreadsheet applications that are GxP compliant.
- Avoid 483s and warning letters.
- What does and does not need to be validated.
- Learn how to use Excel’s built in 21 CFR Part 11 features.
- Apply features required for GxP environments without programming macros.
- Validate your application with minimal documentation.
- Understand how to use risk assessment to reduce testing and improve productivity.
- Participate in the workshop as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.
- Learn how to specify and test your application.
Who Will Benefit:- All Excel users
- IT
- QA, QC
- Laboratory staff
- Managers, Executives
DATE AND VENUE: 26th and 27th July, 2012 at San Francisco Conference Timings: 8 am to 5 pm PDT Venue: Will be announced soon Contact Information:
Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com GlobalCompliancePanel NetZealous 1000 N West Street, Suite 1200, Wilmington, DE 19801.USA |
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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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2012-07-24
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Registration:
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Register now and save $200 (Early Bird) Between May 21 to June 29: $1495
Between June 30 to July 25: $1695
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E-mail:
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support@globalcompliancepanel.com
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