Veterinary Drug Approval Process and FDA's Regulatory Oversight
Karl M. Nobert
60 Min
Product Id: 703971
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Mukesh Kumar
90 Min
Product Id: 703422
This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
Preparing Compliant eCTD Submissions
Antoinette Azevedo
60 Min
Product Id: 700719
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.
Key Factors to Develop an Effective CAPA System
Kim Huynh-Ba
Product Id: 703320
This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.
