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
Price : $245.00
(for one participant)
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 ¡ ¡ ¡ ¡
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.
Areas Covered in the Session: l
What are DMFs?
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:
l l l l l l l
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:
Suggest a Topic
Your Necessity is our Priority
Manufacturing Regulatory Affairs
Global Supply Chain Research and Development
l l l l l
Quality Assurance & Control Validation Development and Preparation of Submission Materials 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
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe