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Documents Day1.3 - Lee - A Filing Reviewer's Perspective

Julia Lee, Pharm.D. Regulatory Support Branch Division of Labeling and Program Support (FDA│CDER│OGD) A Filing Reviewer’s Perspective on Electronically Submitted Documents…

Documents Quality Assurance Chapter 29. Quantitative Chemical Analysis, Daniel C. Harris, 6 th Edition, 2003.....

Slide 1 Quality Assurance Chapter 29. Quantitative Chemical Analysis, Daniel C. Harris, 6 th Edition, 2003. New to this edition and a very important topic in industry today.…

Documents Walter Nowocin, PEM Medtronic, Inc., Minneapolis, Minnesota NCSL International Workshop and...

Slide 1 Walter Nowocin, PEM Medtronic, Inc., Minneapolis, Minnesota NCSL International Workshop and Symposium, Nashville, TN 16 July, 2013 Slide 2  Review metrology related…

Documents The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic,...

Slide 1 The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23 March, 2012…