Report Requirements for Radiation Emitting Products; CeSub & ESG

Albert Cefalo
Instructor Albert Cefalo
Product Id 600048
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Report Requirements for Radiation Emitting Products; CeSub & ESG

Overview:
By attending this webinar the attendee will become familiar with how the process works and what need to be done for access to the FDA ESG.

As anyone in the X-ray Business is aware, the FDA has report requirements for all radiation emitting products. This presentation will provide the attendee with an overview of the report requirements defined by the FDA regulation in 21 CFR Part 1002 – Records and Reports. This will include the various types of reports such as Manufacturer Reports, Assembler Reports, Initial Reports, Supplemental Reports and Annual Reports that the FDA requires for Radiation Emitting Products. This will provide the attendee with an overview of the types of reports shown in Table 1 of 21 CFR 1002.1 – Applicability. This presentation will concentrate on those reports necessary for Diagnostic X-ray and its associated equipment. In an effort to keep ourselves from maintaining mountains of paper to keep on hand and for submittal to the FDA, a variety of these reports may now be compiled electronically using the FDA’s CeSub (Electronics Submission Software) and the electronic submission process via the FDA’s Electronic Submission Gateway (ESG). These recent additions have made the process of report submission much easier and faster with an almost instantaneous accession number received back from the CDRH (Center for Devices and Radiological Health) branch of the FDA. This webinar will provide the attendee with a review of the use of the CESub software and an overview as to how the FDA’s ESG works. The process for acquiring access to the Electronic Submittal gateway can be long and tedious if not done properly.

Areas Covered in the Session:

  • Review of Required Reports for FDA 21 CFR Part 1002 - Records & Reports
  • Concentration on Initial and Annual Reports on X-Ray Equipment
    • Initial Report Content Requirements
    • What Needs to be in the DHF
      • FDA Guidance Documents
    • Annual Report Content Requirements
      • FDA Guidance Documents
    • When Reports are required to be Filed
    • FDA Electronic Report (CeSub Software)
    • FDA Electronic Submission Gateway

Who Will Benefit:

  • Design Engineers
  • Quality Assurance Personnel
  • Program Managers
  • Manufacturing Engineers
  • Regulatory Personnel
  • Engineering Managers
Speaker Profile
Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.

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