Testimonials
“They will always come through for you.”
“It was a pleasure watching the two of you work so well together. I enjoyed your thoroughness and exhaustive follow-up in questioning of all aspects of the vendor’s documents and procedures.”
“…applies common sense along with the scientific and technical knowledge”
“Len Grunbuam’s presentation was the most clearly presented and applicable to daily activities”
“It was clear to me that your involvement beginning the end of last year was critical to the project, and without your participation, I am not sure that our company could have passed the scrutiny of our client or the FDA. The integrity of the data was never in doubt, but the organization’s experience and knowledge regarding documentation was immature – and you provided excellent guidance.”
“Len and Emma are the heart and soul of the Practical Solutions Group. Len’s greatest strength is identifying core problems while Emma’s is in quickly finding solutions to fix these problems. Together, they provide practical and relevant recommendations.”
“It’s always reassuring having such an experienced and stable hand at the tiller during these potentially turbulent audits. Well done!”
“I recently worked with Len and Emma of The Practical Solutions Group on a very important, time-sensitive project. I was extremely impressed with their knowledge and commitment, and the value they brought to our project. They were 100% engaged even when extremely long hours were needed and they continuously pushed our group to ensure a quality product. I would recommend The Practical Solutions Group to anyone and hope to have the pleasure of working with them again in the future. Thank you both for your dedication and support with our projects!”
“Len’s risk management session was by far the most interesting. He gave a very good overview of the topic and generated relevant questions.”
“…excellent in describing the potential impact of computer system risk areas”
“You’re a class act!”
“I did make a special point of attending your presentation. It was excellent as usual. I couldn’t help but think of the standard you have established and maintained. We sorely need that level of excellence in a world where most people are trying to cut corners.”
“It was a real pleasure having an opportunity to meet both of you, and your presentation content was some of the best I have ever seen! We received a lot of positive feedback from your session and we look forward to your continued participation.” FDA Officer
“Emma consistently demonstrates a sense of urgency and proactively anticipates potential obstacles. She is VERY action oriented.”
“The auditor said that he had not seen such high quality of system documentation in prior audits. He said that our documentation was very thorough and complete. This can only be attributed to PSG and everyone in the room knew that as well.”
“…always on target.”
“Len’s approach is both balanced and free of commercial bias.”
“Thanks again for all of your efforts on the audit. Great “Stuff”. Lots of very good information. Nice road map to take us to the next level.”
“Our largest client notified us that they anticipated an FDA audit of a program they were submitting for approval in 2010. They wanted us to put together a preparation plan, to ensure we would do well in such an inspection. I immediately called Emma and Len – engaged them to work with us through the process. In fact, they became co-project managers with one of our people. The client was very impressed with the project plan, as well as with the work that was done over the next 7 months. It is not an understatement to say that we could not have been prepared, had it not been for Emma and Len’s participation.”
“…an extremely passionate person about her work… an effective communicator with a great personality”
“…well versed on international views and expectations for validation risk management.”
“It’s always reassuring having such an experienced and stable hand at the tiller during these potentially turbulent audits. Well done!”
“We are always thankful that you sit on our side of the table”
“The Quality System of the Austin office received a very favorable audit summary, and (0) non-conformities. This is a testimony to the relationship that we have developed with The Practical Solutions Group. Many thanks again for all of your assistance!”
“I just wanted to inform you that as of about an hour ago we received our approval letter from FDA CBER for our medical device. I just wanted to make sure you were among the first to know since your inspection played such an integral role in our preparations for the GMP inspection. It was a long and difficult journey, but we made it and I just wanted to share a little of that joy with those who helped make this possible.”