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Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar

By:
David Nettleton, FDA Compliance Specialist, Computer System Validation
Location 1:-
Courtyard New Orleans Downtown, LA

Thursday, May 15, 2014 | Friday, May 16, 2014
Location 2:-
San Diego, CA

Thursday, July 24, 2014 | Friday, July 25, 2014
Location 3:-
Seattle, WA

Thursday, Aug 21, 2014 | Friday, Aug 22, 2014

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.

Course Description:

Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.

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.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Students learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.

This course benefits anyone that uses 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.



Learning Objective:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
  • Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
  • "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


Who will Benefit:

This course benefits anyone that uses 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.

  • Regulatory Affairs
  • QA/ QC
  • IT/IS
  • Software Managers
  • Project Managers
  • Software vendors and suppliers




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

0. Introduction to class (30 minutes)
1. Introduction to the FDA (60 minutes)
  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11.

2. 21 CFR Part 11 - Compliance for Electronic Records and Signatures (150 minutes)
  • What Part 11 means to you, not just what it says in the regulation.
  • Avoid 483 and Warning Letters.
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
  • Ensure data integrity, security, and protect intellectual property.
  • Understand the current computer system industry standards for security, data transfer, and audit trails.
  • Electronic signatures, digital pens, and biometric signatures.
  • SOPs required for the IT infrastructure.
  • Product features to look for when purchasing COTS software.
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

3. HIPAA Compliance for Electronic Records (60 minutes)
  • How Part 11 and HIPAA interrelate
  • What are the additional requirements for patient data

4. The Five Keys to COTS Computer System Validation (60 minutes)
  • The Who, What, Where, When, and Why of CSV

5. The Validation Team (30 minutes)
  • How to select team members
  • How to facilitate a validation project

6. Ten-Step Process for COTS Computer System Validation (60 minutes)
  • Learn which documents the FDA expects to audit.
  • How to use the risk-based validation approach to lower costs.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

7. How to Write Requirements and Specifications (30 minutes)
  • Workshop for writing requirements and then expanding them for specifications

8. How to Conduct a Hazard Analysis/Risk Assessment-Exercise (60 minutes)
  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

9. Software Testing (60 minutes)
  • Reduce testing by writing test cases that trace to elements of risk management.
  • How to write efficient test cases

10. System Change Control (60 minutes)
  • How to manage a validated system with minimal documentation

11. Cost Reduction Without Increasing Regulatory or Business Risk (60 minutes)
  • How to save money
  • How to increase quality
  • How to increase compliance with less documentation




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.





Register Online

$1,699.00

Seminar One Registration

May 15-16, 2014, New Orleans, LA
(Early bird price valid till April 20, 2014)
Actual Price: $1,899

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May 15-16, 2014, New Orleans, LA
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Seminar One Registration

July 24-25, 2014, San Diego, CA
(Early bird price valid till April 20, 2014)
Actual Price: $1,899

$7,699.00
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July 24-25, 2014, San Diego, CA
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August 21-22, 2014, Seattle, WA

$8,599.00
$11,394.00
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August 21-22, 2014, Seattle, WA
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Register Now and Save $200 (Early Bird Price)
For Registrations till April 20, 2014 $1,699
Actual Price $1,899
Early Bird Seats are limited and based on first-come, first-serve.Complementary USB Drive for first 20 Registrations

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436

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Yes, I want to attend "Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar"

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
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Palo Alto, CA 94303
USA

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Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

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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)

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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 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.

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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.

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Venue

Location 1:



View Larger Map


How to Reach

Driving Directions:

From Louis Armstrong New Orleans International Airport – MSY (12 mile(s) W)
  • Take I-10 E to US Highway 90 W
  • Exit 11C toward Tchoupitoulas St/ S. Peters St
  • Continue straight one block
  • Turn left onto S. Peters, go 6 blocks to Julia St. and make a left
  • The hotel entrance is immediately on the left on the corner of Julia/S. Peters

Other Transportation:

Bus Station
  • Greyhound Bus Lines-0.7mile (s) W

Train Station
  • Amtrak- New Orleans Union Passenger Terminal -0.7 mile (s) W

Disclaimer: Directions to the venue above have been taken from the hotel website. ComplianceOnline is not responsible for any inaccuracies in the same. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue.



Location 2:


Location 3:




Testimonials

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






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New Orleans, LA, Local Attractions

San Diego, CA, Local Attractions

Welcome to the birthplace of jazz, New Orleans. Every night of the week, the streets and clubs of the Big Easy are still alive with vibrant music. From traditional jazz to acid jazz, there's something for every ear, every day of the week.




With over 45 museums throughout the city to choose from, it's easy to immerse yourself in the city's history, culture and arts.




One block over from the raucousness of Bourbon Street is the French Quarter’s more refined and elegant epicenter of local artistic culture. Royal Street is an eye-pleasing mix of classy antique shops and boutiques, fine jewelry stores, colorful art galleries and world-class hotels and restaurants.




There’s a reason so many visitors flock to the French Quarter every day – both locals and tourists can’t get enough of the unique area’s unique attractions. From the beautiful architecture to art galleries, museums, restaurants, and bars, the French Quarter has something for everyone – no matter what your interests, budget, or age may be. Join up with a tour and learn more about the fascinating history of the area, or spend the entire day exploring and shopping in the area, topping everything off with an excellent meal in a world-famous restaurant and some live music. With so much culture, history, and entertainment, you’ll find a unique and exciting experience around every corner.




Although this historic French Quarter street has a bawdy reputation due to the burlesque clubs and all-night partying, come experience a whole other side of Bourbon Street steeped in history, folk lore and beauty that dates back to 1718 when New Orleans was founded by Jean-Baptiste Le Moyne de Bienville. Also known as “Rue Bourbon,” this historic street sits at the heart of the French Quarter extending 13 blocks from Canal St. to Esplanade Avenue.



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.




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.




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.






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