Combination Products: Managing Design Controls - Webinar CD/Transcript

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Combination Products: Managing Design Controls

Planning to submit a new combination product for FDA approval? Then consider this:

The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize.

The Guidance addresses an often overlooked aspect of product regulation — the design control of the device component. Insufficient compliance can lead a Complete Response Letter that denies your application for failure to consider and/or address design control elements.

FDAnews has stepped into this knowledge gap with an all-new Webinar featuring Ricki Chase, former Director of the FDA Investigations Branch and now a management consultant. Ms. Chase analyzes this all-important final guidance ... for you. Prepare to learn:

  • How design controls apply to combination products, including biologic/device and drug/device combinations ...
  • How already available information can help speed new products to market ...
  • Why a device isn’t a combination product: Designing for the differences ...
  • Using human factor studies to support combination-product submissions ...
  • And much more!

A Complete Response Letter can spell defeat for years of planning and design, not to mention hundreds of thousands of wasted dollars. Don’t take that risk.

  • Drug GMP executives
  • Device GMP executives
  • Design/validation engineers
  • Contract manufacturers
  • QA/QC/QR
  • Regulatory affairs

Ricki Chase, Director, Lachman Consultant Services Inc. Ms. Chase is former Director of the FDA Investigations Branch, where she was responsible for all operations including inspections, investigations, sample collections, consumer complaints, import operations and emergency response programs. Ms. Chase is an expert in implementation of food and drug law, compliance law, and current Good Manufacturing Practice enforcement. She received numerous recognitions and awards for outstanding contributions while at the Agency, and is a frequent industry association speaker and guest lecturer.