Format for Making Regulatory Submissions to Ensure a Quicker Approval

Duration: 60 Minutes
This discussion is intended to 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.
Instructor: Jerry Dalfors
Product ID: 501118
Regulations in 21 CFR 314.50, 314.94, and 601.2 provide general requirements for submitting NDAs, ANDAs, and BLAs, respectively. This section addresses briefly some general issues related to providing marketing applications in paper format. Ensuring we understand the terms and expectations associated with amendments and supplements once a product submission has been approved and then we have to make some changes as result of following the current PV statistical regulations. Although the CTD and the RTD describes what we submitted and is to be used in the local area when an inspection occurs, so all employees are telling the stories. The initial submission included a portion of the Common Technical Document (CTD) and Technical Registration Document (TRD) documents on file in your facility. The FDA will consider, on a case-by-case basis, accepting submissions where some modules are provided in the CTD and TRD format and the rest of the submission is not the exact same format. Setting up the pre NDA/BLA meetings with the FDA prior to ever submitting the final submission is always required and generates a much higher probability of them understanding the whole process which then ensures a more effective and quick acceptance of the submission to allow the product to be marketed.

Objectives of the Presentation
  • CTD format for each submission, common technical document summaries, quality, nonclinical study reports, clinical study reports - examples
  • CTD / TRD - general design of buildings and facilities, pressure differentials and airflows / air handlers
  • CTD / TRD - brief description of production operation, product flow and equipment flow
  • CTD / TRD - instruction and training of personnel, personnel flow and gowning procedures to generate operational quality minimizing product damage or contamination
  • CTD / TRD - qualification/validation of computer systems, all process operations, building services, stability, etc
  • CTD / TRD - detailed description of major equipment, product bulk connections, sip and associated controls-general overview
  • CTD / TRD - description and validation of support utility systems, compressed air distribution system and other related validation needs
  • CTD / TRD - description and validation of miscellaneous equipment, as well as ultrasonic washers/cop - general overview of all
Why Should you Attend
Generate the technical comprehension and technical writing capabilities to eliminate corporate interpretations and translations of technical terms relative to the specifics of your specific process. We always want to submit the submission in a way that does not require any interpretation, so that when the FDA reads the documents they come to the exact same conclusion we did to generate the production process for this product ensuring we are not generating any patient risk.

Who can Benefit
  • Senior Management
  • Regulatory Affairs
  • Quality Systems Personnel
  • R&D and Engineering Staff
  • New Product Development
  • Compliance Managers
  • Manufacturing Engineers
  • Consultants
Topic Background
Confidential - technical registration document request and routing form. Attach supporting documentation, such as an approved QA change, if needed along with clinical results as needed. The submission will not be processed unless all supporting documentation is attached (validation, TRD, CTD, clinical results, etc.) Review of the needed documents and objective evidence that provides needed detail to gain easy and quick approval of a product, by preparing a Common Technical Document and the Technical Registration Document for the registration of pharmaceuticals for human and veterinary use as the submission to the U.S. Food and Drug Administration (FDA).
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Instructor Profile:
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.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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