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.
• Learn what does and does not need to be validated.
• Configure spreadsheet applications for Part 11 compliance without programming macros.
• Learn how to use Excel’s built in 21 CFR Part 11 features for audit trails, security, data verification, and multiple concurrent users.
• Validate your application using validation templates.
• Avoid 483s and warning letters.
• Use risk assessment to reduce testing and improve productivity.
• Learn how to specify and test your own GxP Excel application.
Day 1 – 26thJuly 2012
Lecture 1: Introductions validate your own Excel spreadsheet application
Lecture 2: Regulations for Electronic Records
Lecture 3: 21 CFR Part 11 - Electronic Records & Signatures
Lecture 4: The Risk-Based Valid
Lecture 5: 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 - 27thJuly 2012
Lecture 6: How to Conduct a Hazard Analysis/Risk Assessment
Lecture 7: Excel Applications - Part 2
• Create a Hazard Analysis document for your application
• Create a Testing Protocol document for your application
Lecture 8: Main Concepts to Remember
Lecture 9: Q&A
Who Will Benefit
• All Excel users
• Laboratory staff
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.
DATE AND VENUE:
26th and 27th July, 2012 at San Francisco
Conference Timings: 8 am to 5 pm PDT
Venue: Will be announced soon
Price – $1,695.00
Toll free: 1800 447 9407
Fax: 302 288 6884
1000 N West Street,
Suite 1200, Wilmington,