Analytical Method Validation and Transfer According to the New FDA Guidance

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Tremendous effort that can be expended in conducting validation studies, efficiency of experimental design

  • 30-November--0001| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Fast Track New Managers: Make Sure They Have the “Right Stuff” to Be Peak Performers

By: Marcia Zidle ,Executive and Leadership Coach.

Skills and techniques to successfully transition into a new role and become a peak performer

  • 05-March-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Focus substantive review on submissions that are complete

  • 13-March-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Back to Top