I have over 30 years hands-on experience in the fields Pharmaceutical, Dietary Supplement and Medical Device Quality Assurance. My experience covers In-coming, In-process and Finished Product inspection and release, Sterile and Non-sterile manufacturing, process validation, supplier certification, document control, statistical analysis and process improvement as well as software development and implementation. I have also had substantial experience in Batch Record Review, Product Disposition, NCR/CAPA, Product Complaint Systems, Supplier Certification and Change Control.I have had experience implementing, monitoring and ensuring compliance with CFR parts 111, 210, 211, 820 and CFR part 11. I have also had significant face-to face time with local, federal and international Regulatory Agents. My experience also includes extensive knowledge of cGMPs, SPC, ISO and FDA/EU requirements.