This short video explains, in simple terminology,
what Computer System Validation is,
and how it saves your company money!

Lab5 - Webdesign Schweiz 

A Good Experience for Me

Validation was a good experience for me, since this was first time I validated a program. As a team, we learnt a lot about why validation is important as well as figured out some loopholes within the system. Without David, this process would have been impossible. He was great to work with and also was instrumental at figuring out the loopholes within the system.

– Pharmaceutical company
Houston, TX

A+++

Your training class was extraordinarily beneficial in our efforts to advance to advance our Part 11 initiative.

- Seminar participant

Almost Immediate Implementation

I wanted to say that I really enjoyed the Computer System Validation class in San Diego and I've been able to implement ideas you presented almost immediately upon my return.

- Seminar participant

At a Critical Point

At a critical point in the validation project senior management promptly approved the contract to hire David Nettleton, one of the nation's leading consultants. Without David Nettleton, the project would have not gone live as scheduled and would not have been compliant with Part 11.

- Pharmaceutical company
Palo Alto, CA

Best speaker

Best speaker of the conference. Outstanding material, technically correct, and good regulatory interpretations.

- Conference delegate, San Diego, CA

Bridged the Gap

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

Comfortable Now

I wanted to take a moment to that you for yesterday's presentation.  Not only was it educational and enlightening, but it was also very entertaining. It was actually a pleasure for me to attend.  Of course, I still have many validation questions, but am very comfortable with the concept now.

- Pharma participant

 

David Helped Us

David helped us make our software development process efficient and helped us to understand how the regulations affect our customers.

– Software Vendor
Vancouver, BC

Dedication and Professionalism

Thanks for the report and the references to the EDC vendors. I greatly appreciate your dedication and professionalism and learned a  lot from you on how to audit. I think you did a great job there and I sincerely hope that we will continue working together.

– Pharmaceutical Company
Reykjavik, Iceland

Defendable System

Thanks for your excellent presentation yesterday. The workshop was very informative and helpful regarding your 10-step team-based approach to developing defendable system and validation documents to achieve regulatory compliance for computer systems. 

– Conference attendee
Philadelphia, PA

Documentation Maze Book Review

Managing the Documentation Maze is an excellent reference source in an easy-to-follow Q&A format for all healthcare professionals involved in the drug discovery process, development and manufacture of therapeutic products. Questions regarding all aspects of document management, validation, regulatory compliance, transition to electronic systems are clearly answered is an uncomplicated style by the authors, based on their extensive industry experience.

- Book Reader

Exactly what I was looking for

Wow.  This is exactly what I was looking for.  You are awesome – this was the best class I’ve ever taken (college, professional training, etc).

-Seminar participant

 

Excellent Teaching Skills

I want you to know how thankful I am for the excellent training that I received during these two days in June 2006. Not only the content of the course was great, but your excellent teaching skills made the course easily memorable and understandable. There are two words to express my opinion about the course "made professionally"! Besides that, I really appreciate the numerous hints that were generously given to us - these are priceless.

– PTI Student
San Francisco

Excellent, Excellent, Excellent

I want to thank you for bringing in David today.  It was Excellent, Excellent, Excellent.  We are trying to pin down our process and procedures and this really gives us a better sense, at least for a 21 CFR Part 11 standpoint, of where we should pay attention.  All I can say is when can we get more.

– Medical device company
San Diego, CA

Eye opening

Many thanks for your eye opening course this week. It was exceedingly useful to hear from someone who has practical real-life experience rather than someone who is simply interpreting the regulations. 

- Seminar Participant

Sydney, Australia

Fantastic workshop

I attended today's workshop, "Implementing and Sustaining a Records Systems That Will Meet Regulatory and Intellectual Property Requirements" at the Pennsylvania Convention Center, which by the way I thought was fantastic.

- Conference attendee, Philadelphia, PA

Good at Communicating

I hope to be able to attend another training seminar with you in the near future.  You are very good at communicating the message with fun and flair!

- Seminar participant

Great Information

Thank you, thank you, thank you for all of the great information. Our President and CEO was very pleased with it.

– CRO
Indianapolis, IN

Great Two Days

First I wanted to thank you for a great two days packed of wonderful and very useful information.  I have been to Part 11 seminars before but this was the only I walked away with a clear understanding of what is required, why, and how to perform it correctly.

- Seminar participant

Helped us leap

You helped us to leap from having ‘0’ process to having a reproducible system to produce quality validation and SOP document. Super effective learning.

- CSV Manager

How Useful Your Course Actually Was

I'm currently sitting in a software training course that is definitely not worth the time away from my job, and it reminded me of how useful your course actually was.

– PTI Student
Philadelphia

I Learned the Industry Standards that I Can Use at Work

I've been to a few training courses and didn’t really learn much but in David's course I learned the industry standards that I can use at work.

– Training Course Participant
Chicago, IL

ISBT Certificate

isbt-certificateThis is to certify that Dave Nettleton has contributed to the ongoing development of the ISBT 128 Standard, as a participant of The Cellular Therapy Coding and Labeling Advisory Group, in the year 2013.

– ISBT 128 Certificate
signed by Paul Ashford
Executive Director, ICCBBA

Make a Dry Topic Interesting and Fun

Thank you very much for presenting to the group. There was a lot of energy, questions and very positive comments afterwards. Many said they wished that everyone had your energy level and could make a dry topic interesting and fun. We really appreciate your support of our efforts to provide important topics to these professionals.

– Industry group organizer
San Francisco, CA

Make Documentation Easy

The 10-steps for computer system validation make documentation easy.

– Pharmaceutical company
San Francisco, CA

More Fun than My Regular Job

Validation isn’t as bad as I thought. Working with David was fun, more fun than my regular job.

– Document Control Specialist
Seattle, WA

No 483s

After we attended David’s training, we implemented the procedures he recommended, and we just had our first FDA inspection with no 483s.

– International Pharmaceutical Company
Amman, Jordan

Personalized Medicine Custom Software Validation

Thank you so much for the list of notes and for such an immensely informative and productive week. We certainly appreciate your personal commitment to quality and excellence along with your ability to make what could have been a tedious and painful process actually quite enjoyable.

- QA Director

Presentation with humor

Thanks very much for yesterday's presentation regarding FDA compliance issues. Everyone found it very useful and appreciated your sense of humor. 

- Software Vendor

Durham, NC

See the True Fruits of Your Labor

She [the auditor] said the audit package we presented was the best she had seen (and she is extremely experienced). She is very impressed by how clean, easy to follow and thorough your resulting product is. David, sometimes you cannot see the true fruits of your labor until some time and events have passed.

- Pharmaceutical QA Director, Houston, TX

Seminar cleared up questions

I really enjoyed last week’s COTS Software Validation class.  Thank you for spending a good amount of time on explaining the specifics of 21 CFR Part 11.  This was the area I needed the most help understanding and you did a great job of clearing up any Part 11 questions I had previous to the class.

- Software Quality Engineer

Small Business Needs

David understands the needs of a small business and was able to provide us with great value. His understanding of his field is detailed and confidence inspiring. He is an effective teacher who doesn't want to keep coming back and charging more and more - instead he made us self sufficient, capable, and confident in our compliance needs. He is a very hard worker who makes the very most of his time with clients.

- Client, San Diego

Superb training

On behalf of all of us here, I want to thank you for a superb training session today.  What you taught us is exactly what we needed and I look forward to the journey working with you over the next 6 months as we get our act together for FDA compliance.

- Custom Software Developer

BC Canada

Thank you so very much!

David Nettleton was very clear and concise on a confusing subject. He had my complete attention (during lunch that is not easy). Wonderful delivery of timely information. Excellent job.

- Webinar participant

The Best Training I've Had in Years

I took your "Complying with Computer and Software Validation Requirements" through PTi in February (San Diego). This is just an unsolicited positive review of that course -- I've since had a couple of other training courses (completely different topics, completely different companies), and I just wanted to let you know that your course was probably the best training I've had in years. I've told anyone who asked that I'd recommend your course to others, no question.

– PTI Student
San Diego

The training helped with our internal CSV procedure

I attended your 2-day CSV course "Electronic Records and Signatures:  From 21 CFR Part 11 to HIPAA" via the UC Santa Cruz extension program (during the Winter 2008 term), and would like to thank you for a very informative course.  The information was very helpful in drafting my employer's internal CSV procedure.

- Class participant, Santa Clara, CA

University Course Feedback

Experienced and enthusiastic instructor.

Got me to think about validation a different way, the end users’ perspective.

The instructor’s knowledge of the subject was outstanding.

David was a very lively and dynamic teacher. He has extensive knowledge of the topic and has many supporting real life examples.

He made regulation fun.

The course exceeded my expectations.

Great course.

- U of CA Students

Very Impressed

I was very impressed with your presentation and the energy you put into the event. You should know that the staff left the teleconference very excited. I am a bit surprised at the level of excitement, but I think it is due to the fact that you demystified many topics that had become complex and complicated.

– CEO CRO Services Company
Nashville, TN

Very Useful Course

Very useful course - I would recommend it to anyone.

– Biotech company
Waltham, MA

We Completed the Project in One Week

With David’s help we completed the project in one week.

– Biotech Company
Boston, MA

We Completed the Project in One-Third the Time

David provided leadership for the team, so we all knew what was expected of us. We completed the project in one-third the time.

– Medical Device Manufacturer
Houston, TX

Wonderful Seminar

I just wanted to thank you again for your wonderful seminar – I still use the materials that you provided. The knowledge that I acquired during the seminar makes me more confident. We already performed a few improvements in our validation system, and keep getting better.

- Seminar Participant

Your Counsel and Advice Has Been Superlative.

You helped me prepare.

Your counsel and advice has been superlative.

- Senior Quality Manager

Your training course was phenomenal

I just wanted to thank you for all of the insight that you provided over the last few days.  Your training course was phenomenal.  I wish all teachers shared your laid back, fun, and example-based approach.  It was great that you took the time to figure out what was important to all of the folks in your audience.  It really made the learning personal.

- Training Participant

Chicago, IL

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:

Risk Based Software Validation
Risk Based Software Validation - Ten easy Steps

Electronic Record Keeping
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Managing the Documentation Maze
Managing the Documentation Maze
Read a Review

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.