Event Detail
Drug Master Files (DMFs) - Understanding & Meeting Your Global Regulatory and Processing Responsibilities
February 16, 2010
- Live Webinar CANADA
BenAstrum
Live Web Training Course Tuesday, February 16, 2010 (9:20 a.m. - 11:30 a.m. EST) (8:20 a.m. - 10:30 a.m. CST) (6:20 a.m. - 8:30 a.m. PST) Instructor: Robert J. Russell Learning Objectives: Upon completion of this course, participants will understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.