TypeOnline Course
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DMF and SMF preparation

Drug Master File summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development.  This online, self–paced course provided comprehensive understanding about the Drug Master Files – Classification, Guidelines and preparing effective documentation.

Participant will be understanding different types of DMFs, and detailed understanding of each class. This course provides detailed understanding with all real life examples. Upon completion of the course, attendees will be able to begin developing or to improve upon their DMF file documentation.

Duration: 3 Days

Learning Objectives:

  • Introduction to DMFs – Classification. Explanation / understanding of each class of DMF.
  • Review the five types of DMFs and their uses.
  • Able to develop the information to be contained in the DMF.
  • FDA Submissions
    • What to include and what not to include
    • Format
    • Essential information
    • Key documents
    • Assembly/ Binder Specifications
    • Delivery
  • Understand when the DMF should be filed with the FDA.
  • Be able to describe experiences of others regarding real world issues associated with creating and submitting DMFs.
  • Able to use a checklist to construct a DMF from scratch.
  • Ongoing obligations
    • Changes to DMF
    • Transfer of ownership
    • Closure of a DMF
    • Retirement of DMF

Who will Benefit:

  • Person working in the pharmaceutical manufacturing deaprtment
  • Regulatory Affairs personnel
  • Research and Development personnel
  • Quality Assurance & Control personnel
  • Validation personnel
  • Development and Preparation of Submission Materials

Certification: Certificate will be provided at the end of the course after completion of the final examination.

Section 1Key Consideration for Drug Master File Preparation and Submission 
Section 2Practical Understanding on Drug Master File Preparation and Submission
Section 3Detailed understanding on Site Master File
Section 4DMF Completeness Assessments
Section 5Drug Master File - Fees [US]
Section 6DMF - Global Perspective
Section 7Final Certification Examination