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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:-
Grand Hyatt San Francisco, CA

Thursday, December 4, 2014 | Friday, December 5, 2014
Location 2:-
Scottsdale, AZ

Thursday, Feb 5, 2015 | Friday, Feb 6, 2015
Location 3:-
San Diego, CA

Thursday, March 26, 2015 | Friday, March 27, 2015

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

Interview with
David Nettleton, FDA Compliance Specialist


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.

 
Interview with
David Nettleton, FDA Compliance Specialist



Register Online

$1,699.00

Seminar One Registration

December 4-5, 2014, San Francisco, CA

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Seminar One Registration

February 5-6, 2015, Scottsdale, AZ
(Early bird price valid till December 15, 2014)
Actual Price: $1,699

$1,399.00

Seminar One Registration

March 26-27, 2015, San Diego, CA
(Early bird price valid till December 15, 2014)
Actual Price: $1,699


Register Now and Save $300 (Early Bird Price)
For Registrations till December 15, 2014 $1,399
Actual Price $1,699
Early bird seats are limited and based on first-come, first-serve.

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:
2600 E. Bayshore Road
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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7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

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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 @ editor@complianceonline.com

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.

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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 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Venue

Location 1:

Special Offer for the attendees of this seminar:

Rooms available at 15% discount and with free internet.

Use the code "CR88975" at the time of booking to avail of this offer.

Please note: Hotel rooms are limited and based on availability.




View Larger Map


How to Reach

General Driving Directions:

From San Francisco International Airport: 14 miles
  • Take 101 North toward the San Francisco and Bay Bridge.(Cambridge)
  • Exit 280 North toward "Port of SF/280 North". Stay in left lane and 280 becomes King Street.
  • At 2nd light, turn left onto 3rd St and go 8 blocks to Market St.
  • Cross over Market St. (which becomes Kearny St.) and continue 2 blocks.
  • Turn left on Sutter St. Go 2 blocks to Stockton and the hotel is located on the left corner.

From Oakland Airport: 20 miles
  • Take 880 North toward San Francisco and cross over on the Bay Bridge.
  • Take the Fremont St. Exit (on right) & proceed 1/2-block on Fremont St.
  • Turn left onto Howard St & Turn right onto 3rd St.
  • Cross Market St. (Street changes to Kearny).
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left.

From San Jose International Airport: 46 miles
  • Take 101 North toward San Francisco for approximately 43 miles
  • Take I-80 East toward Bay Bridge/Oakland.
  • Exit at Fourth Street toward Embarcadero.
  • Make a slight left onto Bryant Street.
  • Then a left onto Third Street & Third Street will become Kearny Street.
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left to reach the Hotel.

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.



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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  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

 




San Francisco, CA, Local Attractions

Scottsdale, AZ, Local Attractions

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.




The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.




A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.




City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.




San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity



Downtown Phoenix offers something for everyone including, museums, performing arts venues and a thriving art scene as well as a large sports presence. Chase Field is home to the Arizona Diamondbacks and the US Airways Center is home to the Phoenix Suns, the Phoenix Mercury, the Arizona Rattlers and the Phoenix Roadrunners.




METRO is now open and operating with traffic in the cities of Phoenix, Tempe and Mesa. At any time of the day or night, you can find yourself near an operating light rail vehicle or a METRO train consisting of two or three vehicles connected together.




The Cactus League has been an Arizona tradition for over a half-century. What began as a two-team league in 1947 has grown to twelve Major League Baseball teams playing in seven cities throughout the state. The league's popularity is at an all-time high with games scheduled every day in March. The Cactus League offers baseball enthusiasts an excellent opportunity to enjoy their favorite teams in fan-friendly, state-of-the-art ballparks.




Be sure to bring your camera as the desert offers spectacular sunsets and beautiful scenery year round.




Red Rock State Park in Sedona (110 miles) is an open-sky theatre of fabulous rock formations. Sprawled across 286 unspoiled acres, this popular park is the perfect starting point for hiking, picnicking, bird watching and photography.




Cathedral Rock in Sedona is 110 miles away and offers a great hiking trail for the adventurous. Cathedral Rock, also known as 'Lovers', was thought to be created by the Great Spirit. A couple of lovers, who always argued, were asked by Him to look around at the beautiful surroundings and count their blessings. The couple was believed to never argue thereafter and stands in perfect harmony.







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