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Training by Compliance4all on Understanding and Meeting your Regulatory

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Description: 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. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Areas Covered In the Session:

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

Who will benefit: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

Speaker Profile
Robert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance.

URL: http://www.compliance4all.com/control/w_product/~product_id=501057LIVE
Status: Deleted
Date: Tuesday, December 6, 2016
Time: 3:00pm-4:30pm UTC
Duration: 1 hour 30 minutes
Access: Public
Category: Webinar*, Education*, Environment*, Finance*, Food and Beverage*, Health*, Industrial*, Marketing*, Technology*, Business*
Created by: compliance4all
Updated: Thursday, October 27, 2016 12:00pm UTC
Cost ($): One Dial-in One Attendee Price: $150.00
Call In Number: 18004479407
Contact Email: support@compliance4All.com
Contact Person: Event Manager
Contact Phone: 18004479407
Comments: None


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