Project Management for Medical Device Regulatory Affairs - Training Bundle

How can you as a regulatory affairs project manager drive value to compliance processes in medical device projects?

Following the new MDR Date of Application in May 2021, the year is significant for the Medical Devices market. The new IVDR takes effect on May 26th, 2022, which means that all new IVD devices placed on the market after that date must be CE marked in accordance with the IVDR.

Due to regulatory changes and the tendency toward more high-tech solutions, business strategies are becoming more crucial, and your role as a project manager is becoming more important. More regulations, oversight, and stakeholders are having a dramatic effect on how medical device projects are conducted in the future.

ComplianceOnline has engaged elite experts to present to you a clear and in-depth understanding of the regulatory basics and project management approaches used in medical device regulatory affairs. You will learn how to coordinate major regulatory requirements for medical devices across project management and develop a good understanding of the core components required for successful projects.

See what’s covered in the training bundle

Project Management for FDA-Regulated Companies
The Use and Mis-use of FMEA in Medical Device Risk Management
New European Medical Device Regulation (MDR) 2017-745
EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
Construct and Manage the Technical File and Design Dossier
Change Management for Regulated IT Processes

Project Management for FDA-Regulated Companies

This training will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Areas Covered in the Webinar:

• Meet key requirements of the CGMPs/ISO; Quality Plans
• "Failing Fast" Formal Lean Project Management
• The Three Most Common Tools - Gantt, CPM, PERT
• Work breakdown Structure, Milestones, Tasks
• Drive Success or Failure Fast; Fast Cycle / Agile Principles
• The Build, Measure, Learn, Re-evaluate Loop
• Example: A Suggested New Product Template
• One Major, But Often Neglected, Use

The Use and Mis-use of FMEA in Medical Device Risk Management

The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.

Areas Covered in the Webinar:

• How should I use FMEA in performing risk management?
• What are the problems with FMEA in risk management?
• How should detectability be used in FMEA?
• Is there a role for RPN (Risk Priority Number)?
• Are there other tools to use in conjunction with FMEA?
• Are there FMEA applications in production as well as design?

New European Medical Device Regulation (MDR) 2017-745

This webinar will discuss main differences between current EU Medical Device Directive (MDD) 93/42/EEC and new EU Medical Device Regulation (MDR) 2017-745 and how to ensure compliance with the new MDR requirements.

Areas Covered in the Webinar:

• Device classification
• Conformity routes
• General Safety and Performance Requirements (GSPRs)
• Technical documentation
• Post market surveillance (PMS)
• Clinical evaluation
• UDI
• EUDAMED
• Economic operators

EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.

Areas Covered in the Webinar:

• The new scope of the EU IVDR 2017/746
• The obligations and roles of the EU IVDR 2017/746
• How work the regulation and the EN ISO 13485:2016 together?
• New and updated processes required by the EU IVDR 2017/746

Construct and Manage the Technical File and Design Dossier

Learn the techniques for audits and Technical File reviews. We will discuss the difference between Technical File and Design Dossier and explain how to create them and the best practices.

Areas Covered in the Webinar:

• Learn the differences between the Tech File and Dossier and why the construction phase is so important.
• Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately.
• Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”.
• Determine exactly which materials need to be assembled.
• NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate.
• Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s).
• Determine applicable standards and address company-specific SOPs for constructing and managing your files.
• European Norms and Standards and other documents supporting Technical Files and Design Dossiers.
• Guidance on Design-Dossier Examination and Report Content.

Change Management for Regulated IT Processes

The Current GMPs and global standards established by the FDA and numerous global regulating authorities require that Information Technology operations under their auspices demonstrate sound Change Control practices as a fundamental tenant of Configuration Management in general.

Areas Covered in the Webinar:

• Defining the scope of Change Management
• Establishing a compliance model
• Principles of Configuration Management
• Laboratory Control Systems
• Manufacturing Systems
• Change Control Processes
• Maintaining compliance

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