ComplianceOnline

Course Description:

Course "Excel spreadsheet validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.


Course Objectives:

  • 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 1

   

Day 2

  • Introductions
  • Regulations for Electronic Records
  • 21 CFR Part 11 - Compliance for Electronic Records & Signatures
  • Efficient Risk-Based Computer System Validation Document
  • Excel Application Workshop part 1
    • Develop User Requirements validation document for your application
    • Develop Project Plan validation document for your application
    • Develop Functional Specifications validation document for your application
   
  • How to Conduct a Hazard Analysis/Risk Assessment – Exercise
  • Excel Application Workshop part 2
    • Develop Hazard Analysis validation document for your application
    • Develop Testing Protocol validation document for your application
  • Main Concepts to Remember
  • Q&A



Meet Your Instructor

David Nettleton
FDA Compliance Specialist, Computer System Validation

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 196 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project




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Terms & Conditions to register for the Seminar/Conference/Event

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 @ editor@complianceonline.com

Payment:
Payment is required before 2 days of 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 from 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 before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Testimonial:

What past attendees say:

This was one of, if not the best, most informative, enjoyable trainings I've attended in my 11 year career and I have been to many. David was simply an outstanding presenter. In this class, there was much participation and people learn from other's questions. Overall I had a very positive experience and brought back value to my company.
- Lead Auditor, Delavau L.L.C

I enjoyed the seminar very much. I am hoping to be able to implement some of the things I learned in my own work efforts. I thought David was an excellent facilitator and he kept the pace moving along properly to cover all of the material in time.
- Sr. Validation Engineer, Stryker Orthobiologics

I thoroughly enjoyed the seminar! The content of the seminar was excellent.
-Associate Director, Pfizer Global Supply

David was a dynamic presenter; I like his answers and interaction immensely. I really liked the support materials.
- Project Manager, SNC Lavalin Pharma

This was a very well seminar. The location, the food, the training material were all very much appreciated. David was a very charismatic, knows his stuff and presents the info in a way that making it entertaining.
- Winfred Holloway, Software Quality Manager

Great dynamics between instructor and participants. The program was well organized and coordinated. Large amount of data was delivered in short time period.
- Engineering Electrical Controls Manager, S.P. Scientific

Seminar was very good, informative and a lovely speaker making a tedious topic interesting. Overall the subjects are well chosen and the program was well organized and coordinated.
- Director - Global IT Governance, Perrigo

The training was excellent and I encountered no difficulties either with the registration process or during the event. This was one of the better trainings that I have attended over the years.
- Sr. QA Engineer, PrimeraDx

I thoroughly enjoyed the seminar! The content of the seminar was excellent and I would recommend it to others.
- Associate Director, Quality Operations, Pfizer Global Supply

I was very confident in David Nettleton's knowledge on the subject matter.
- Research & Development Associate, Ceremed Inc.

After we attended David's training, we implemented the procedures he recommended, and we just had our first FDA inspection with no 483s.
- Pharmaceutical company, San Francisco, CA

Thanks for finding me and giving me the opportunity to take this session. I like all the topics, especially 21 CFR Part II Compliance. David Nettleton is a phenomenal instructor. The amount of interaction between the participants and presenters is ideal which help us to explore more. I would strongly recommend this seminar.
- Technical Writer, S.P. Scientific





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Media Partner Benefits
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  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

 



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