Risk-based Computer System Validation; Reduce Costs and Avoid 483
FDA Compliance Specialist, Computer System Validation
(9:00 AM - 3:00 PM PDT)
FDA Compliance Specialist, Computer System Validation
This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
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.
For discounts on multiple registrations, contact customer care at +1-888-771-6965.
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 @ +1-888-771-6965 or email us @ email@example.com
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 $300 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 ($300) will be transferred to any future FDATrainingAlert 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 FDATrainingAlert cancels the seminar, FDATrainingAlert 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 FDATrainingAlert 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 FDATrainingAlert for marketing, archiving or any other conference related activities. You agree to release FDATrainingAlert for any kind of claims arising out of copyright or privacy violations.
See What People Say About Us
Really good location with good lunch. This seminar was full of valuable topics.
This is my first experience with ComplianceOnline and I would definitely attend other seminars.
It was a knowledgeable seminar. Thanks for inviting me. I will attend upcoming seminars on ISO 13485 and Sterilization validation.
I love to receive your email alerts. It keeps me updated with all valuable trainings. You have variety of offerings.
All topics were informative and interesting. Database validation was the most valuable topic for me as I was hired for this job function. David is excellent and personable speaker; his knowledge and experience provide credibility and exceptional insight. Overall it was a wonderful event. Excellent choice of venue, materials and food was arranged by ComplianceOnline!!!
Thanks ComplianceOnline. Your website is very accessible and communicates well. It covers many compliance topics. For this seminar venue was convenient for west cost. Sometimes I cannot travel so attend those trainings online.
David is an excellent instructor, very animated and has a great energy level. He was able to really engage with the attendees.
David is one of the best presenters I have seen. This subject was well presented by him.
A former attendee of this seminar referred me. David was great with shuns while keeping everybody engaged.
It was a great seminar. I like the topic Hazard/Risk Assessment. I do all other validation activities as David presented but didn't evaluate my specs for Risk but I can really see how this will benefit the whole validation process and am definitely adding it.
I literally don't have any suggestions to improve your future seminars. I just love it. The presenter was very entertaining and informative.
Thanks for coordinating this seminar. Customer service was very good, event was well arranged and good meal was a plus.