“…Kevin Randall did an excellent job elaborating on the slides, stating not only the FDA regulations, but also the real world expectations for the regulations…”
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GMP Training Attendee
“…Training was very good for the whole team, and being able to be present and attend to specific requests was most valuable. Working through all the issues identified, Kevin was able to propose and guide through many solutions…”
GMP Training Attendee
“…Kevin’s pace and speaking style brought life to the regulations…”
GMP Training Attendee
“…Kevin’s interaction and communication is always respectful and clear. He has demonstrated an ability to explain concepts in a manner which is applicable to the audience…”
GMP Training Attendee
“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”
GMP Training Attendee
“…Kevin was very engaging throughout the presentations. His content was well presented, and the slides coincided with the presentation. Overall, I learned a lot from this program…”
GMP Training Attendee
“…I really appreciated how examples of the Preamble were often cited, as the FDA also cited the importance of them in their training…”
Director, Development and Manufacturing Operations – Class II device Manufacturer
“…I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework.”
President – Class II & III device Manufacturer
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly […]
VP Regulatory and Scientific Affairs, Class III devices
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”