The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

Date : 12th April 2018 to 13th April 2018

Place : United States, Philadelphia, pa

Website :https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901462SEMINAR?allconferencealerts-April-2018-SEO

Contact Person:Event Manager

Description:

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in 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 lie 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. The course will include the current review and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted. Upon completion of this course, attendees will understand how to prepare Quality Agreements, Drug Master Files (DMFs) with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance and the strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs, present strategies for establishing and maintaining effective change control programs, along with facilitating effective communications with regulatory agencies along with customers and vendors. The course will also discuss the movement by U.S. FDA to convert from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901462SEMINAR?allconferencealerts-April-2018-SEO

The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities will be held in Philadelphia, pa,United States on date 2018-04-13

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Deadline for abstracts/proposals : 11th April 2018

Keynote Speakers : This course is developed for those involved in the manufacture of Pharmaceutical, Biologic and Medical Device 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

Conference Highlights :Regulatory Affairs Project Managers Global Supply Chain Research and Development Quality Assurance & Control Validation Development and Preparation of Submission Materials General Management

Venue :Philadelphia, PA, USA

Check the event website for more details.