Developing Integrated cGMPs and Regulatory Strategies for Combination Products

1 Hour Video | Khaudeja Bano, AbbVie

This webinar covered the following topics:

  • Navigating an ambiguous regulatory path to meet current good manufacturing practice requirements
  • Setting an internal quality and regulatory strategy for a combination product portfolio
  • Combining skill sets to overcome knowledge gaps between the device and pharmaceutical disciplines
  • Using post-launch usability evaluation techniques to eliminate usability issues in product revisions
  • Foreseeing industry implications as a result of rapid combination product development growth

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

  • Research and Development
  • Regulatory Affairs
  • Quality Assurance
  • Safety

 BANO

Khaudeja Bano, MD

Senior Medical Director, Medical Device Safety Head

AbbVie

Khaudeja is a physician with a master’s in Clinical Research (UCSD), Oracle DBA, PMP and Pharmaceutical Engineering Certification. She is an Abbott President’s award winner, avid Toastmaster and certified coach. Khaudeja has more than 25 years professional experience, including clinical practice for nine years. She has held several global safety positions at Abbott Vascular (AV), Abbott Diagnostics (ADD), Abbott Established Pharma Division (EPD) and now AbbVie. Her career in safety includes leadership roles in devices, diagnostics, pharmaceuticals and combination products.

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