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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

Duration: 90 Minutes

Instructor: Robert J. Russell

Location: Online

Price : $245.00

 

  

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(for one participant)

Instructor Profile:

Overview:

Robert J. Russell President, RJR Consulting, Inc.

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

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. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry. ...more

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.

Why you should attend: The course offers methodologies and techniques on: l

Quality Agreements ¡ The Origin and Background around Quality Agreements ¡ ¡ ¡ ¡

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

DMFs ¡ ¡

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¡ ¡ ¡ ¡

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.

Areas Covered in the Session: l

What are DMFs?

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The rationale and preparation process for DMFs DMF Preparation: What you need and why you need it FDA Review: How FDA reviews DMFs and why. Components Associated with a DMF:

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Japan DMFs European DMFs Canadian DMFs 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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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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Quality Agreements with Pharmaceutical - Biologic Manufacturersand the Use of Drug Master Files