Autoren

1994–1998 Bachelor of Science in Biochemistry, Minor in Chemistry, University of Rochester, Rochester, NY

1999 Graduate Coursework at the Worcester Polytechnic Institute, Worcester, MA (Operations Management & Medical Device Quality & Regulations)

1998–2003 KMI/Parexel Consulting, Manager Equipment Qualification (Laboratory, Production, Filling, Packaging and Labeling), Process Validation (Biologics) and Computer Systems Validation (Lab Equipment, DCS, PLC, HVAC, LIMS, SAP, EDMS etc.) across Pharmaceuticals, Biologics and Medical Device industries. Compliance Audits, GMP Assessments & Supplier Qualification Assessments

since 2003 Clarkston Consulting, Regulatory & Compliance Manager: Delivery of strategy and solutions for regulatory compliance in FDA and EMEA regulated pharmaceutical, biotech, and medical device industries (business process improvement, product development, quality systems, and change management). Global project management in the areas of Regulatory and Quality Experience in implementing systems like LIMS, Packaging and Labelling, Clinical Trials Sample Tracking etc. Leader of the “Statutes and Regulations” Center of Excellence for two years; currently leading the “Regulatory Planning and Remediation” Business Solution within Clarkston.

1996–2004 Active membership within Professional Societies (ISPE, PDA, RAPS), Speaker at the Pharma Med Device Conference (2008) and the PDA/FDA Conference (2009), Participation at the Executive Development Program offered through the Northwestern Kellog School of Management on Regu-latory Strategy and Leadership.
Ms. Mukherji has earned the US Regulatory Affairs Certification (RAC) distinction.