InstructorRoyed Training
TypeOnline Course
Price$225 USD / 12375 INR
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DMF and SMF preparation course provides training on drug master file and site master file preparation and filing. The course provides training on facilities, processing, manufacturing, packaging and storage for pharmaceutical products. This is an online, self–paced course. This course covers drug master file Classification, Guidelines and preparing effective documentation. The course also covers how to design Site Master File effectively.
Participants 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. This certification course provides real life training on how to prepare Drug Master File submission dossiers effectively.

Online Interactive Training

This online self paced training. Therefore the course can be accessed 24×7 across anywhere. Hence, the course can be completed at any pace, allowing the user to stop and start at their leisure. 

Course Code: RYD-019

Course Title: Competency Development Program in DMF and SMF preparation

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for different regulatory bodies and practical exposure in drug dossier preparation. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Features of the Course:

  • The course provides practical training on drug master file and site master file preparation and submission. Therefore it helps the participant to identify the marketing tools and techniques which are commonly used in the pharmaceutical industry.
  • Simulation to real life working in drug master file development.
  • The course also provides simulation on Site Master File samples, which gives clear cut understanding of various sections to add in site master file.
  • Above all, this course provides access to the requirement of drug master file to work and develop competency. Certainly, accessing these lectures can be helpful for students to understand section wise requirement for the DMF in the industry

Key Points to Note:

1. Orientation to practical understanding in the entire drug regulation in brief, DMF requirements of different regulatory bodies and practical exposure on DMF preparation.

2. Understanding on DMF and SMF. The course outlines it’s components. Moreover, technical documents and guidelines helps participant to understand submission norms.

3. Simulation to real life Strategic planning in DMF preparation

4. Attend Live Lectures of all different chapters / study content.

Online learning course. So course can be accessed online across anywhere 24×7.

Graduation in any discipline. Even final year graduation students can apply.

1 Week from the date of initiation of the course.

Key Learning Areas

  • 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 department
  • Regulatory Affairs personnel
  • Research and Development personnel
  • Quality Assurance & Control personnel
  • Validation personnel
  • Development and Preparation of Submission Materials
  1. Attend the course 24×7 by login to your dashboard. Therefore, you can attend lectures, simulation, self assessment tests and final certification examination at your own preferred time.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Certificate will be provided at the end of the successful completion of the course.

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Section 1Fundamental Session
Lecture 1Introduction to course
Lecture 2Drug Discovery Stages
Lecture 3INDs | INDs Vs. DMF
Lecture 4NDA Filing | NDA Vs. DMFs
Lecture 5Generic Drugs | ANDA | ANDA filing vs. DMF
Lecture 6BLA | BLA vs. DMF
Lecture 7Abbreviated Biosimilar Pathway | DMF Vs, Biosimilar Applications
Section 2Learning Sessions
Lecture 8Key Consideration for Drug Master File Preparation and Submission 
Lecture 9Practical Understanding on Drug Master File Preparation and Submission
Lecture 10Associated Learning: Site Master File - Key Understanding 
Lecture 11DMF Completeness Assessments 
Lecture 12Drug Master File - Fees
Lecture 13Drug Master File - Global Perspective
Lecture 14DMF Format - Non-CTD to CTD
Lecture 15Electronic DMF | eCTD | Key Points of electronic DMF submission
Lecture 16DMF's CMC compilation
Lecture 17Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 18Letters of authorization
Lecture 19Change of Name of DMF Holder | Closure of DMF
Section 3Final Certification Examination