Quality Agreements with Pharmaceutical - Biologic Manufacturers and the Use of Drug Master Files

Live Webinar on
Quality Agreements with Pharmaceutical - Biologic Manufacturers

and the Use of Drug Master Files: Understanding and Meeting your
Regulatory and Processing Responsibilities
Date & Time:


Thursday, December 8, 2011
10:00 AM PST | 01:00 PM EST

Register Now

Duration: 90 Minutes
Instructor: Robert J. Russell
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Robert J. Russell
This combined Quality Agreement and DMF (Drug Master Files)
President, RJR Consulting,
training will discuss the advantages for suppliers and drug product
Inc.
manufacturers developing these arrangements together.

For the past 9 years, Bob has been
Over time, there have been several misunderstandings between
President of RJR Consulting, Inc. The
supplier / contractors and pharmaceutical / biologic finished product
company assists the pharmaceutical,
manufacturers. The root of many of the problems lies in a lack of a
medical device and biotech
industries in understanding and
suitable agreement delineating roles, responsibilities and resolution
complying with International
to agreement to these issues.
Regulations affecting compliance,

new product development,
Why you should attend:
manufacturing and quality
assurance. RJR has offices in
The course offers methodologies and techniques on:
Columbus, OH, Washington, DC,
Brussels, Belgium with exclusive
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Quality Agreements
affiliates across Asia and Latin
The Origin and Background around Quality Agreements
America. Bob has 28 years of past
industry experience as a CMC
When are Quality agreements appropriate?
specialist, R&D Director and Global
The Scope of Quality Agreements
Director of Regulatory Affairs for
Quality Agreement Formatting and Content
Merion Merrill Dow pharmaceuticals
How to negotiate a Quality agreement
and Cordis-Dow medical devices. He
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DMFs
has a BS / MS degree in Chemistry.
Who really needs a DMF and why?
...more
The various types of DMFs - which is best for your
products.
The relationship between DMFs and drug and biologics
Suggest a Topic
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applications.
The symbiotic relationship between DMFs and current
Your Necessity is our Priority
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.

Areas Covered in the Session:
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What are DMFs?
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The rationale and preparation process for DMFs
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DMF Preparation: What you need and why you need it
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FDA Review: How FDA reviews DMFs and why.
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Components Associated with a DMF:
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Japan DMFs
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European DMFs
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Canadian DMFs
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Change control and maintenance: Why accurately maintaining
your DMFs is important
Click here to register for this webinar
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:

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Manufacturing
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Regulatory Affairs
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Project Managers
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Global Supply Chain
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Research and Development
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Quality Assurance & Control
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Validation
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Development and Preparation of Submission Materials
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General Management
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel
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