Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities - Webinar by GlobalCompliancePanel

MessageThis Webinar is over
Date Dec 17, 2013
Time 10:00 AM PDT
Cost $225.00
Online
Overview: This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. 

Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lies in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files) which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency

Quality Agreements
  • The Origin and Background around Quality Agreements
  • When are Quality agreements appropriate?
  • The Scope of Quality Agreements
  • Quality Agreement Formatting and Content
  • How to negotiate a Quality agreement

DMFs
  • 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.

Webinar 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.
  • 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

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
  • Project Managers
  • Global Supply Chain
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials
  • General Management
NetZealous LLC,
DBA GlobalCompliancePanel 
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA          
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com    
http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1cX27xG

 


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