6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements

  • Check with publisher
  • Published date: February 8, 2021
    • Fremont, California, United States

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.

The conversion of paper to e-filings requirements with FDA will also be discussed. The process used for e-filings will be reviewed in detail. Maintaining filings for Annual Reports and DMF Amendments will also be covered.

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 be prepared, formatting, content and negotiations around the agreement.

The DMF section will explain content, format, preparation and the types of Drug Master Files which can filed in the U.S., as well as the EU, Japan and Canada. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

Areas Covered in the Session
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 (c-GMPs)
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 inspection trends
The conversion from paper to e-filings at FDA for Human and Veterinary Products
Who Will Benefit
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

https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-the-use-of-drug-master-files-&-quality-agreements:-understanding-and-meeting-your-regulatory-and-processing-responsibilities-11641LIVE

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • The Disruptive Practitioner: A Danger to the Hospital's Operation

    The Disruptive Practitioner: A Danger to the Hospital's Operation

    Medical - Health san Jose (california) January 31, 2021 Check with publisher

    This course will train hospital executives, medical staff officers, peer review committee members and support staff on how to deal effectively with disruptive practitioners. Participants will also learn how to prepare for the day when it becomes nece...

  • 6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

    6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

    Medical - Health Fremont (California) December 30, 2020 Check with publisher

    Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and ap...

  • FDA's Medical Device Software Regulation Strategy

    FDA's Medical Device Software Regulation Strategy

    Medical - Health san Jose (california) December 18, 2020 Check with publisher

    The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjun...