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    Live webcast Drug Master Files - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

    View: 320

    Website https://compliance2go.com/product/?pid=CP2014-383 | Want to Edit it Edit Freely

    Category Biotechnology , Pharmaceutical

    Deadline: January 20, 2015 | Date: January 20, 2015

    Venue/Country: Houston, U.S.A

    Updated: 2014-11-28 17:31:37 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    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 reviewed by FDA personnel. Besides the US, the use 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 vendors.

    Why Should You Attend:

    This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFscourse will 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 products and businesses.

    The course offers methodologies and techniques on:

    Who really needs a DMF and why?

    The various types of DMFs - which is best for your products.

    The relationship between DMFs and drug and biologics applications.

    The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).

    Common DMF errors - how to avoid them.

    How to deal with deficiency letters and their origins.

    Effective change control strategies.

    Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.

    Seminar Agenda

    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 errors

    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 success

    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

    1. DMFs as "living" documents. DMF updates and amendments

    2. Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes

    3. What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

    Who Will Benefit:

    This course is developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:

    Manufacturing

    Regulatory Affairs

    Research and Development

    Quality Assurance & Control

    Validation

    Development and Preparation of Submission Materials

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Handouts (PDF print only copy of PowerPoint slides)

    90 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.