My expertise lies in successfully developing and implementing methodologies to ensure that pharmaceutical companies remain cost-effectively GMP compliant to FDA and international Good Manufacturing (GMP) requirements to maximize productivity, efficiency, and revenue growth. Further, I have provided expert testimony and been a witness in US and international court cases and arbitration disputes related to GMP matters.
I have over 35 years of experience working in all aspects of the manufacture of sterile and non-sterile pharmaceuticals, medical devices, and active pharmaceutical ingredients (APIs) - my work includes production, quality control/quality assurance, and product development.
- Medical Devices
Available Upon Request