Summary
This DMFs (Drug Master Files) training will discuss 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

Details

Discount : Get 15 % Discount as a early bird registrations. Use Promocode CGO15

Upon completion of this course, attendees will understand how to prepare and file 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 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 and your own customers and vendors.

Why Should You Attend:
This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFscourse will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. 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.

The course offers methodologies and techniques on:

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.
Seminar Agenda:

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 cGMPs
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
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:

Manufacturing
Regulatory Affairs
Research and Development
Quality Assurance & Control
Validation
Development and Preparation of Submission Materials

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

https://www.compliance2go.com/index.phpoption=com_training&speakerkey=11...

Summary
This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the European requirements for CE Marking and ISO Certification on commercializing products. The history, current processes and latest regulatory environment on all Classes of Medical Devices and Combination Products will be discussed. Learn how to classify your product and how that classification translates to the required data needed to CE mark your product across the EU. You will also be updated on the recent and contemplated changes coming on the EU Medical Device Directives.

Details

Discount : Get 15 % Discount as a early bird registrations. Use Promocode CGO15

Why Should You Attend: This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Key Topics to be Discussed:

The current regulatory situation in relation to Medical Devices in the EU.
The purpose of the Medical Device Directives.
Meeting the New Requirements for Conformity Assessment by Product Type.
Understanding the impact the Directive will have on developing and marketing new Medical Device products.
An overview of key areas of the Directive:
Scope of application and definition
Essential Device Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigation Requirements
Clinical Evaluations
Notified Bodies involvement
Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.
Detailed Agenda of the Session:

Definition: Medical Device or Personal Protective Equipment.
Overview of the Global Medical Device Industry
Standard
Active Implanted
In Vitro Diagnostic
Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective
An Overview of the Medical Device Directives.
Development, aims, implementation and update of the Medical Device Directives
Implication of an EU Directive vs. Regulation
Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products
Update on the additional guidance documents relating to the directives
Essential Requirements
Classification of MD's and Process Implications
Conformity Assessment
Technical File
Relationship to EU Clinical Trial Directive
Guidance Documents.
Medical Device Directive Annexes.
Compliance Requirements by Type
Full Quality Assurance System
Declaration of Conformity
Safety.
Medical Device Vigilance System
Manufacturer's Requirements
GMP
GCP
CE Marking
ISO Certification
Clinical Trials
Labeling
ISO Standard Certification.
Overall process; Management Commitment & Involvement
Role of Notified Bodies
Relationship to CE Marking
ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
ISO-14155 Medical Device Clinical Investigations.
Part I- Clinical Studies
Part II- Clinical Investigations
Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply
Compare & Contrast EU & FDA Procedures and Requirements.
Process Similarities & Differences
Implications for Industry
Company Management
Process Changes
Management Team Effectiveness
Regulatory Approval and Liaison with Regulators.
EU Co-Decision Procedure
Committees, Working Parties Relevant for Medical Devices
When and How to Influence Regulators
Do's and Don'ts of Regulatory Involvement
Individual Company Involvement vs. Trade Association

Learning Objectives:

Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.

Who Will Benefit:

This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:

Clinical research and medical operations
Project Managers
Product Development personnel
Manufacturing personnel
Researchers managing Medical Device R&D and Development
Quality Assurance such as GMP, GCP Auditors
Regulatory affairs
Clinical trial supply personnel
CRO personnel
All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)

About the Speaker:

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

https://www.compliance2go.com/index.phpoption=com_training&speakerkey=11...

• What has changed at EU Level?
• Where are the Member States in implementing the changes?
• What has changed in the UK?
• Practical implementation issues
• Case study
• Managing Risk
• Q&A

This live and interactive webinar will focus on the practical implementation issues arising for UK and EU businesses selling and receiving services across borders. We will look at how companies are coping with the new rules and what challenges they are presented with. We will demonstrate how these challenges can be addressed and how other businesses have dealt with certain implementation issues. Participants will be given the opportunity to ask questions and obtain a practical insight into the new rules in order to understand how to minimize risk and maximize VAT compliance.

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