Live Webinar on: Drug Master Files (DMFs) - Understanding and Meeting Your
Global Regulatory and Processing Responsibilities
Monday, June 18, 2012 duration : 01:00 to 02:30 PM EDT
This DMFs (Drug Master Files) training will discuss the
current review and enforcement climate within FDA
and the manner in which drug master files (DMFs) are
Get 15 % Discount as a early bird reviewed by FDA personnel. Besides the US, the use
registrations. Use Promo Key : CGO15 of DMFs in the EU, Japan, Canada and Australia will
also be discussed. Similarities and differences to the
U.S. system will be highlighted.
Upon completion of this course, attendees will
understand how to prepare and file DMFs with the
FDA and the rationale behind doing so. Participants
will gain practical knowledge about what reviewers
look for in DMFs, the consequences that can be
expected as a result of non-compliance, and
strategies for avoiding the most common DMF-related
errors. The course will also emphasize the "organic"
nature of DMFs , present strategies for establishing
and maintaining effective change control programs ,
along with facilitating effective communications with
regulatory agencies and your own customers and
Why Should You Attend
Live ( Single registration ) : $189.00
This course provides attendees with an understanding
Group ( Max 10 Attendee): $249.00
of the role DMFs play in the FDA's regulatory approval
On Demand (Recording available):$289
process for drugs and biologics. The DMFscourse will
Get Training CD : $499
take participants through a step-by-step process of
DMF preparation and explain the types of information
essential for any Drug Master File. Additionally, this
course explains why "one size does not fit all" and
emphasizes the importance of customizing DMFs in
both preparation and maintenance for particular
Who will benefit products and businesses.
The course offers methodologies and techniques on:
This course is developed for those involved in
the manufacture of pharmaceutical and Who really needs a DMF and why?
biologic products, components, and packaging The various types of DMFs - which is best for your
materials. The course will be especially useful products.
for personnel responsible for: The relationship between DMFs and drug and
Manufacturing The symbiotic relationship between DMFs and current
Regulatory Affairs Good Manufacturing Practices (cGMPs).
Research and Development Common DMF errors - how to avoid them.
Quality Assurance & Control How to deal with deficiency letters and their origins.
Validation Effective change control strategies.
Development and Preparation of Submission Ramifications of inadequate preparation and/or
Materials maintenance and recent enforcement actions and
More Trainings What are DMFs?
Types of DMFs (Types II, III, IV and V)
The rationale and preparation process for DMFs
Why DMFs are important to you and your company
How DMFs fit into FDA's regulatory processes for
review of drug and biologic applications
Why, more than ever, you may need DMFs to
maintain current supplier agreements as well as to
develop new business relationships
What not to include
DMF Preparation: What you need and why you need it
The essential components of all DMFs, including:
The relationship between DMFs and cGMPs
Tactics for avoiding the most common DMF-related
Tactics for dealing with unique or novel
FDA Review: How FDA reviews DMFs and why.
What you should expect throughout the DMF
preparation and filing process
How to communicate and work with FDA to ensure
Components Associated with a DMF:
DMF vs. Application
Letter of Authorization
Changes to a DMF
Obligations of a DMF holder
Transmissions - transmittal letter
Changes to DMF system in last 10 years
Binder specifications and cover sample
Change control and maintenance: Why accurately
maintaining your DMFs is important
DMFs as "living" documents. DMF updates and
Types of DMF-related changes that impact
drug/biologic applications: production facilities,
composite materials, manufacturing processes
What you must report and to whom - the importance
of establishing communication pathways with
regulatory agencies, customers and vendors
Robert J. Russell is President and CEO of RJR
Consulting, Inc, a leading Global Regulatory
Consulting firm focusing on assisting the Life
Science Industry. Prior to founding the firm in
2000, Mr. Russell had over 27 years of experience
in CMC, Global Business Development and
Regulatory Compliance for pharmaceuticals,
biologics, medical devices and combination
products. The company has an office in Brussels,
Belgium where they interact with the European
Commission and the Competent Authorities across
the EU. Country establishment, marketing
authorizations, variations and license renewals are
core competencies of the course director. Mr.
Russell has received a B.S. and M.S.in Chemistry.
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