Course Description:
This two-day seminar teaches how to develop and validate Excel spreadsheets for 21 CFR Part 11 compliance. This training event covers all of the required features that have to be configured in Excel. In class you will create the validation documents for an application that you develop. We will use the risk based computer system validation approach that typically saves two thirds of the validation time and costs. This event will make you a better Excel user and help you avoid FDA 483s. The validation approach can be applied to all types of Excel applications and other Commercial Off-The-Shelf applications.
Note: Participants must bring their laptop computer in order to develop and validate an Excel application.
Learning Objective:
- 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
Course Outline:
DAY ONE (8:30 AM – 4:30 PM) | DAY TWO (8:30 AM – 4:30 PM) | ||
Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
David Nettleton FDA Compliance Specialist, Computer System Validation Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project. |
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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
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