Upcoming Events at DoubleTree by Hilton Philadelphia Airport
Thu May 31, 9:00 AM - Fri Jun 1, 6:00 PM
DoubleTree by Hilton Philadelphia Airport
4509 Island Avenue, Philadelphia, PA 19153, Philadelphia, PA 19153
Community: Clinton
Description
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.
Event Details
Overview:
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.
Why You should Attend:
This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should b
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.
Why You should Attend:
This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should b
