Company Info






  Home > Archived Webinars >

Implementing MHRA’s New Guidance for Own Brand Labelling or ”Virtual Manufacturers”



 
Our Price: $395.00

Product Code: WB-7252
Qty:

Product Info
 
About the Product
Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) released new guidance which redefines Own Brand Labelling (OBL) as “Virtual Manufacturers” and contains more stringent requirements for demonstrating compliance. Virtual manufacturers with marketed products in the UK are now required to provide full technical documentation and audit quality management systems to corroborate alignment with the mandated regulations. The guidance reflects the EU’s initiative to increase product scrutiny and is expected to have a significant effect on the collaborations between “Original Equipment Manufacturers” (OEM) and OBLs. With the guidance coming into force on September 1, 2017, OEMs and virtual manufacturers have a significant undertaking ahead.
  • Defining and fulfilling requirements for full technical documentation
  • Approaches for handling proprietary data and justification for redaction
  • Improving partnership agreements to ensure universal compliance



Speaker:
Theresa Jeary
Head of the Notified Body for Medical Devices
LRQA



Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Quality Assurance
  • Supplier QA

    Share your knowledge of this product. Be the first to write a review »