is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Wednesday, October 6th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
New FDA requirements for electronic drug establishment registrations and drug listings took effect June 1, 2009. Many firms were initially surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. The challenges continue, as new validation rules are implemented, and as scrutiny of file content increases.
To make successful submissions, firms must not only have a technology solution in place (ESG account and SPL R4 file preparation and editing software), they must have a comprehensive understanding of file content requirements, of typical validation errors and how to avoid or overcome them. All of this may be accomplished through internal efforts or with help from a service provider.
This audio conference provides an overview of the current FDA requirements for drug registration and listing, and shares valuable insight gained over the past year.
