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 is necessary and important because it 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 - 27th June 2013Lecture 1: Introductions  Lecture 2: Regulations for Electronic Records  Lecture 3: 21 CFR Part 11 - Electronic Records & Signatures  Lecture 4: The Risk-Based Validation Approach  Lecture 5: Excel Applications - part 1Create a User Requirements document for your applicationCreate a Project Plan document for your applicationCreate a Functional Specifications document for your applicationDay 2 - 28th June 2013Lecture 6: How to Conduct a Hazard Analysis/Risk Assessment  Lecture 7: Excel Applications - part 2Create a Hazard Analysis document for your applicationCreate a Testing Protocol document for your applicationLecture 8: Main Concepts to Remember Lecture 9: &AWho Will Benefit:All Excel usersITQA, QCLaboratory staffManagers, ExecutivesAbout Speaker:  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. It 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 225 mission critical software validation projects.DATE, VENUE & PRICE:Location: Washington DC | June 27th & 28th, 2013 | 9 AM to 6 PM EDT  Venue: Courtyard Washington Capitol Hill/Navy YardPrice: $1,295.00Register now and save $200. (Early Bird) Until March 29, Early Bird Price: $1,295.00  from March 30 to June 25, Regular Price: $1,495.00 Contact Information: Event CoordinatorToll free: 1800 447 9407Fax: 302 288 6884