Course "Computer System Validation - Reduce Costs and Avoid 483s" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.
This course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will:
Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.
Understand what is expected in Part 11 and Annex 11 inspections
Avoid 483s and Warning Letters
Learn how to buy COTS software and qualify vendors
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe
David Nettleton, FDA Compliance Specialist
Who will Benefit:
This course will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
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.
Interview with David Nettleton, FDA Compliance Specialist
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
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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).
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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.
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DoubleTree San Diego Downtown
1646 Front Street, San Diego,
California, 92101, USA
From San Diego International Airport / Lindbergh Field, CA: 2.6 miles
Depart from San Diego International Airport / Lindbergh Field, CA (0.1 mi.)
Keep left toward N Harbor Dr (0.4 mi.)
Turn left onto N Harbor Dr (1.4 mi.)
Turn left onto W Grape St (0.3 mi.)
Turn right onto Columbia St (0.2 mi.)
Turn left onto W Date St (0.1 mi.)
Turn right onto Union St (0.0 mi.)
Arrive at Union St on the left (0.0 mi.)
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
Philadelphia, PA(Venue to be announced shortly)
May 14-15, 2015
San Francisco, CA(Venue to be announced shortly)
June 25-26, 2015
Really good location with good lunch. This seminar was full of valuable topics. - System Admin, IT
This is my first experience with ComplianceOnline and I would definitely attend other seminars. - Business System Analyst
It was a knowledgeable seminar. Thanks for inviting me. I will attend upcoming seminars on ISO 13485 and Sterilization validation. - Director of Quality
I love to receive your email alerts. It keeps me updated with all valuable trainings. You have variety of offerings. - Test Engineer
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!!! - Software and Training Support Specialist
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. - Director, Validation
David is an excellent instructor, very animated and has a great energy level. He was able to really engage with the attendees. - Business System Analyst
David is one of the best presenters I have seen. This subject was well presented by him. - Manager, IT
A former attendee of this seminar referred me. David was great with shuns while keeping everybody engaged. - VP Global CRM & Business Solutions
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. - Business System Analyst, Documentation
I literally don't have any suggestions to improve your future seminars. I just love it. The presenter was very entertaining and informative. - Test Engineer
Thanks for coordinating this seminar. Customer service was very good, event was well arranged and good meal was a plus. - Sr. Manager, IT
I am more confident about ability to carry out Computer System Validation. David provides Comprehensive information in a way that makes sense. He's patient, passionate about what he does, and provides great examples! Thank You, David! - Director Technical Services
Thank you ComplianceOnline. Staff was very supportive, good choice of topic and content. Everything was valuable there. Thanks again! - Director, Agile Systems and Processes
You made the Complex Simple!!! - Business Systems Manager
It’s Great!!! The low and courts approach really put a new perspective on validation. The FDA isn't who you should be worried about. - Project Engineer
Lots of information provided during the seminar. Not presented in 'Traditional' Validation training. Not Cook Book. - Software Quality Assurance
Loved David's opinions - Made it a rich event. My suggestion to improve future events "please don't change a thing". Very best wishes!!! - Global Quality Operations Analyst
David helped us make our software development process efficient and helped us to understand how the regulations affect our customers. - Software Vendor, Vancouver, BC
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
I can tell David has a lot of experience with computer system validation because David bridged the gap between IT, QA, and Clinical. - Contract Research Organization, Los Angeles, CA
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
I really enjoyed the class. I thought the information that David Nettleton gave us was real world examples of the way Computer System Validation should be done. I have suggested to a few of my colleagues to review the information that we were given at the Computer System Validation Reduce Costs and Avoid 483. - Lisa Wyeth
This was one of, if not the best, most informative, enjoyable trainings I've attended in my 11 year GMP 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
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
I thoroughly enjoyed the seminar! The content of the seminar was excellent. - Associate Director
Seminar was very interactive and applied real time instances. 10 step process and Hazard Analysis were the most valuable topics for me. The support materials are very useful. - QA/RA Manager
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. If I had one criticism, it would be not understanding how I am going to change the culture of mine and other companies that spend so many dollars on validation projects that drag on and on. In David’s world, he can complete a project in a week of planning and implementation; in my world, people spend the first week just letting the concept of a project sink in, and then maybe get started within a month or so. I’d like to be able to expedite projects in the way he has laid out; we’ll see how it goes. - Sr. Validation Engineer
Electronic Signature topic was very valuable for me because we are implementing a document management system. The presenter is very knowledgeable; the amount of interaction between the participants and presenters was good. - Information Technology Specialist
The course was well prepared. I like the "10 steps of validation" topic, I will apply this to all of my programs. It was great to make new connections, informal conversations with other participants during the networking hours was very beneficial. Speaker was very interactive. I will recommend this course and ComplianceOnline.com to others. - IT Director
David was a dynamic presenter; I like his answers and interaction immensely. I really liked the session on "Reduction of Cost" and support materials. - Project Manager
I really enjoyed the class. I thought the information that David Nettleton gave us was real world examples of the way Computer System Validation should be done. I have suggested to a few of my colleagues to review the information that we were given at the Computer System Validation Reduce Costs and Avoid 483.
The registration was an easy process. I forwarded the information to our Human Resources and they were able to handle it from the beginning.
- GCP Manager
I really appreciate the presentation given on topic "The 10 step approach". Overall program was well organized and coordinated. Experience with speaker was good, it was an engaging presentation. Informal conversation with other participant was beneficial.
- Assistant Manager of Technical Development
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.
- 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
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
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
I thoroughly enjoyed the seminar! The content of the seminar was excellent and I would recommend it to others.
- Associate Director, Quality Operations
This was one of, if not the best, most informative, enjoyable trainings I've attended in my 11 year GMP career and I have been to many. David was simply an outstanding presenter. I think the thing that sets him apart from others, in addition to his obvious expertise and knowledge in computer validation, is that he is what today I feel is rare: a good teacher.
David as a teacher is very engaging. The normal nervousness of attendees has little chance of survival in David's class. He breaks through the ice, gets people comfortable and maintains a high level of professionalism. This creates an open atmosphere where people are free to think and ask questions. I generally am not afraid to ask questions and many times I feel alone in that. But in this class, there was much participation and people learn from other's questions. I attribute this to David's personality and approach to getting attendees involved.
In terms of improvements, the only thing I would change would be to have the lunch in a room where people could network (i.e. round tables) vs. coming back into the training room where you sat next to one person. The venue itself was great and the food was fantastic. The Ritz Carlton is a great location. Their service was also excellent.
Overall I had a very positive experience and brought back value to my company. I just wish I had more of a chance to network with the other attendees, although I did connect with a few.
- Lead Auditor/Sr. Laboratory Compliance Specialist
It was a very good experience, the presenter had very good knowledge on the topic but I would added more time to perform a “mini validation” using his templates so that more questions will come that will allow us to learn more.
He explained very well the concepts and gave good examples however is when we do things by our selves that we better understand and make the concepts "ours"
The place and lightening was fine, there was no noise interrupting.
- Software Validation Engineer
I was very confident in David Nettleton's knowledge on the subject matter.
- Research & Development Associate
I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon. - Director of Regulatory Affairs, Nickell Physician & Pharmacy Services
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.
Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.
Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.
San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.
In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.
Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.
Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.
The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.
National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”
The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.
The Barnes Foundation
The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.