Drug Master Files (DMFs)

Venue: Toronto

Location: Toronto, Ontario, Canada

Event Date/Time: Feb 25, 2008 End Date/Time: Feb 26, 2008
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Description

Accurately maintaining your DMFs is important

An Important Two Day Comprehensive & Interactive Seminar, On:

- Drug Master File Overview
- What are DMFs?
- Types of DMFs
- The rationale and preparation process for
DMFs
- 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
- Why your DMFs must be crafted for your
particular products, practices, and business
- 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.
- A preventative approach
- 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
- European DMFs- differences
- Why accurately maintaining your DMFs is
important
- DMF updates and amendments
- Types of DMF-related changes that impact
drug/biologic applications: production
facilities, composite materials,
manufacturing processes
- Establishing an effective change control
program
- What you must report and to whom
the importance of establishing communication
pathways with regulatory agencies, customers
and vendors

Venue

Toronto
Toronto
Ontario
Canada
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