Regulatory Submissions

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Wed, Oct 14, 2015
Length
90 minutes
Product Description

Review the Needed Documents & Objective Evidence Required to Gain Easy and Quick Approval of a Product from the FDA

The general requirements for submitting BLAs, NDAs, and ANDAs are provided by the regulations in 21 CFR 314.50, 314.94, and 601.2. The section briefly addresses a few general problems related to supplying marketing applications in paper format. It ensures that we understand the expectations and terms related with Amendments and Supplements after the approval of product submission and then, as result of following the current PV statistical regulations, we have to make some changes.

A portion of the Technical Registration Document (TRD) and CTD documents on file in your facility is included in the initial submission. The FDA considers on a case by case basis, where it accepts submissions where some modules are provided in the TRD and CTD format, the format is not the exact same for the rest of the submission. Prior to ever submitting the final submission, it is always required to set up the NDA/BLA meetings with the FDA. It thus creates a more conducive environment for them to conceptualize and internalize their understanding of the whole process, which in turn ensures a smoother submission path and acceptance that allows the product to be marketed.

Attend this session by Jerry Dalfors, an expert with 40+ years of experience in the biopharmaceutical and medical device industry, to know about the ins and outs, the guidelines and challenges of regulatory submissions to the FDA. Jerry will review the needed documents and objective evidence that provides required detail to gain easy and quick approval of a product, by preparing a Common Technical Document (CTD) and the Technical Registration Document (TRD) for the registration of pharmaceuticals for human and veterinary use as the submission to the U.S. Food and Drug Administration (FDA).

He will also describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the FDA expectations to approve the submission.

Session Highlights:

  • CTD FORMAT FOR EACH SUBMISSION, Quality, Nonclinical Study Reports, Common Technical Document Summaries , Clinical Study Reports – Examples as follows
  • CTD / TRD - General Design of Facilities and Buildings, Airflows / Air Handlers and Pressure Differentials
  • CTD / TRD – Overview of Production (Operation, flow of Equipment and Product)
  • CTD / TRD - Generate operational quality minimizing product damage or contamination by Instructing and Training of Personnel, Gowning Procedures and Personnel Flow
  • CTD / TRD - Validation /Qualification of all process operations, Computer Systems, building services, stability, etc
  • CTD / TRD - Detailed Description of Major Equipment, Product Bulk Connections, SIP and Associated Controls-General Overview

Who should attend?

  • Senior Management 
  • Regulatory Affairs
  • Quality Systems Personnel
  • R&D and Engineering Staff
  • New Product Development
  • Compliance Managers
  • Manufacturing Engineers
  • Consultants

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Jerry Dalfors

Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.


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