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.

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

Learning Objectives:

The course offers methodologies and techniques on:
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 (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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

November 5th, 2021 (11:00 AM - 5:00 PM EDT)

  • 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
  • What are DMFs?
    • Types of DMFs (Types II, III, IV and V)
  • The rationale and preparation process for DMFs
    • Why DMFs are important to you and your company
    • How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
    • Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
    • What not to include
  • DMF Preparation: What you need and why you need it
    • The essential components of all DMFs, including:
    • The relationship between DMFs and c-GMPs
    • Tactics for avoiding the most common DMF-related errors
    • Tactics for dealing with unique or novel situations/unfavorable reviews
  • FDA Review: How FDA reviews DMFs and why.
    • What you should expect throughout the DMF preparation and filing process
    • How to communicate and work with FDA to ensure success
  • Components Associated with a DMF:
    • DMF vs. Application
    • Acknowledgement Letter
    • Letter of Authorization
    • Changes to a DMF
    • Annual updates
    • Obligations of a DMF holder
    • Transmissions - transmittal letter
    • Deficiency letter
    • Auditing Vendor
    • Inside tips
    • Changes to DMF system in last 10 years
    • Binder specifications and cover sample
  • Japan DMFs
  • European DMFs
  • Canadian DMFs
  • Change control and maintenance: Why accurately maintaining your DMFs is important
    • DMFs as "living" documents. DMF updates and amendments
    • Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
    • What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Robert J. Russell

Robert J. Russell
President and CEO, RJR Consulting, Inc

Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 19 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.

Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • We need below information to serve you better

     

    +1-888-717-2436

    6201 America Center Drive Suite 240, San Jose, CA 95002, USA

    Follow Us

    facebook twitter linkedin youtube

     

    Copyright © 2023 ComplianceOnline.com MetricStream
    Our Policies: Terms of use | Privacy

    PAYMENT METHOD: 100% Secure Transaction

    payment method