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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.
Students, 2010
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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
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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 |
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Thank you, thank you, thank you for all of the great information. Our President and CEO was very pleased with it. – CRO
Indianapolis, IN |
Very useful course - I would recommend it to anyone.
– Biotech company
Waltham, MA |
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 |
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 |
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 |
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 |
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 |
David helped us make our software development process efficient and helped us to understand how the regulations affect our customers.
– Software Vendor
Vancouver, BC |
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 |
The 10-steps for computer system validation make documentation easy.
– Pharmaceutical company
San Francisco, CA |
Validation isn’t as bad as I thought. Working with David was fun, more fun than my regular job.
– Document Control Specialist
Seattle, WA |
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 |
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 |
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 |
With David’s help we completed the project in one week.
– Biotech company
Boston, MA |
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 |
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 |
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 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 |
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