BIOGRAPHY

Christine Park

Consultant, Christine Park & Associates, Villa Rica, GA, USA

Solution-focused and results-oriented Business Executive with extensive Business Development/Quality Systems/ Regulatory Affairs experience. Proven success and business acumen to integrate quality into daily business activities while reducing costs. A pragmatic, common sense approach to defining and establishing good business practice to achieve goals with quality and assurance to regulatory compliance. Experience in the R&D or general manufacturing arena for the Medical Device, IVD, and Biotech/Pharmaceutical environment. Extensive experience with ISO 9001 (including transition to 2015), ISO 13485 (including transition to 2016), 21 CFR 820, 600’s, 200’s, ISO 14971. ICH Q

7, 8, 9, 10, CMDR, MDD,MDR, MDSAP JPAL, planning and hosting FDA inspections, ISO assessments, Notified Body assessments, customer and supplier audits. Qualified Trainer for QMS (13485, 9001, 22716, GDP, GMP

- 820, 210, 211, 111, 110, 11), MDR/IVDR, MDSAP, FSSC 22000 Food Safety