On-Demand webinar

How to Avoid Common Problems with your Design, Risk, and Validation Documentation

Watch the Free Webinar

 

Consider these scenarios...

  • You don’t have access to the previously recorded information from your design history file...
  • One of your colleagues mistakenly submits an outdated version of a document to an FDA inspector...
  • You're unable to show the traceability of your design and development activities...

...because they happen more often than not. And at that point, it's only a matter of time before the nonconformances, complaints, 483’s, warning letters and more start rolling in the door.

This presentation will provide simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk, systemic issues, and those unwanted scenarios above.

Specifically this webinar will cover: 

  • How design and development activities are connected to your quality management documentation
  • Why you shouldn’t view your design controls as disconnected items
  • Why it’s important to document your design and development activities properly the first time
  • Why the belief that design and development documentation slows or hinders development is a myth
  • How the most progressive device companies are utilizing tools that enable clean trace matrices
  • The future state of these tools and how they’re trending toward becoming the industry standards
  • Q&A Session

Who should attend?

  • Medical Device Executives

  • Regulatory Affairs Professionals and Management

  • Quality Professionals and Management

  • Clinical Affairs Professionals and Management 

  • R&D Engineers and Management

 
 

Presenter

 Jim Cassi-1

Jim Cassi
Senior Consultant
Halloran Consulting Group

Moderator

 jon-speer-round

Jon Speer
Founder & VP QA/RA
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.

 

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ABOUT Halloran Consulting Group

Halloran Consulting Group makes life science companies better at what they do. Working with biopharma, medical device, and digital health companies, we understand that every organization has different needs. Halloran focuses on clinical, regulatory, strategic planning, and due diligence with younger clients, while offering direction and expertise to transform mature life science companies into more efficient organizations. Our seasoned experts provide the guidance crucial to long-term success. Visit their website to learn more.

 

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