Drug Master Files _DMFs_ Understanding and Meeting Your Global Regulatory and Processing Responsibilities by compliance2go


									 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
                                                      biologics applications.
   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
                                                      inspectional trends.

                                                      Seminar Agenda
    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
                                                      situations/unfavorable reviews
                                                      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
                                                      Acknowledgement Letter
                                                      Letter of Authorization
Changes to a DMF
Annual updates
Obligations of a DMF holder
Transmissions - transmittal letter
Deficiency letter
Auditing Vendor
Inside tips
Changes to DMF system in last 10 years
Binder specifications and cover sample

Japan DMFs
European DMFs
Canadian DMFs
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

About Speaker

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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