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Unlocking the Mystery of Essential Performance Requirements for Combination Products

 
  January 20, 2022  
     
 
xtalks.com, webinar
Wednesday, February 16, 2022 | 11am EST (NA)


Who Should Attend?

This webinar will benefit in professionals involved with:

  • Device Development
  • Regulatory
  • CMC
  • Combination Products
  • Research and Development (R&D)
  • Quality
  • Engineering
  • Product Development
  • Device Innovation
  • Technology Expert combination products
  • Operations
  • Device Innovation

What You Will Learn

Register for this webinar to learn about:

  • The latest regulatory expectations including ICH Q12 & Established Conditions (EC)
  • The combination product development process and using testing to inform it
  • Strategies to de-risk the combination product development process and use testing
  • Lifecycle management considerations
 
 
Organized by: xtalks.com
Invited Speakers:

Speakers

Fran DeGrazio, Chief Scientific Officer, West Pharmaceutical Services, Inc.

Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in injectable drug products, including vial container closure systems and prefillable systems for combination products. Fran has held numerous technical roles at West, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs. In her current role as Chief Scientific Officer she is responsible to leverage scientific and regulatory understanding across the enterprise.

Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.

Message Presenter
http://Jennifer%20Riter,%20West%20Pharmaceutical%20Services,%20Inc.

Jennifer Riter, Senior Director, Business and Technical Operations, West Pharmaceutical Services, Inc.

Jennifer L. Riter is Senior Director, Business and Technical Operations for the Services and Solutions organization at West Pharmaceutical Services, Inc., Exton, PA. She joined West in August 1996 as an Associate Chemist in the Quality Control group. Her experience blends knowledge of West’s components, containment and delivery systems with hands-on experience of providing technical support and analytical solutions for packaging, delivery systems and combination products to West’s multi-national customers. Ms. Riter has also spoken at several symposiums on analytical testing of parenteral packaging components, devices and combination products as well as on extractables and leachables analysis. Ms. Riter is a member of the Board of Directors for the Lock Haven University Foundation, American Association of Pharmaceutical Scientists, Parenteral Drug Association, and Healthcare Businesswoman Association. She earned a Bachelor of Science Degree in Biology/Chemistry from Lock Haven University, Lock Haven, PA and an MBA in Pharmaceutical Business at the University of the Sciences in Philadelphia, Philadelphia, PA.

Message Presenter
 
Deadline for Abstracts: na
 
Registration: https://xtalks.com/webinars/unlocking-the-mystery-of-essential-performance-requirements-for-combination-products/
E-mail: shunte@xtalks.com
 
   
 
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