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Risk Management

July 21 @ 6:00 pm - 7:00 pm UTC-7

$10 – $100

Panelists:

Janet Michener Whipple, Partner at Validant

James Wabby, Executive Director, Regulatory Affairs, AbbVie

Carolyn White, Executive Director, R&D Quality, Allergan/AbbVie

Program Manager:

Susan Bain, OCRA 2021 President-Elect

 

Synopsis: 

Emerging Technologies and Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management.

During the panel, we will explore various challenges and opportunities utilizing the risk management standard within the product development space to ensure patient safety and product quality.

*Feel free to email questions ahead of time! [email protected]

 

 

 

Panelist Bios: 

Janet Michener Whipple, Partner at Validant

With over 25 years of experience, Jan has a comprehensive background in Quality, Regulatory Compliance, Design, Operations, and Project Management in Medical Devices, In Vitro Diagnostics, and Combination Products with some of the largest and most respected companies, as well as small/mid-sized start-ups.

Most recently, Jan served as the project team lead for multiple clients at Validant. While consulting, Jan’s responsibilities included leading Quality Management System integrations for multiple product/company acquisitions and divestitures, tech transfers and plant closures, preparation for Notified Body audits and agency inspections and leading backroom activities during audits/inspections, quality system harmonization and remediation, Risk Management remediation, project management for New Product Introductions, rebranding & labeling associated with changes in the EU Authorized Rep and Notified Bodies, implementation of ISO 14971:2012, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP), as well as planning for the European Union Medical Device Regulation (EU MDR). Jan has led multiple Quality System area improvements, including CAPA, Design Control, Risk Management, Supplier Management, Documentation Control, and Post-Market Surveillance.

 

James Wabby, Executive Director, Regulatory Affairs, AbbVie

Over 19 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. In addition, an adjunct assistant professor at USC – School of Pharmacy – Regulatory and Quality Sciences.

Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

• CMC Global Dossiers and Global Device Regulatory Strategy Registrations
• EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
• 21 CFR Part 3 and Part 4 – Combination Products
• CE Marking
• ISO 13485:2016/MDSAP
• Product Development – Design Controls
• Risk Management
• Human Factors Engineering
• Acquisitions/Divestitures
• Import/Export – U.S. Agent
• Production Controls
• Regulatory Inspection Management
• Materiovigilance
• Health-Care Related Laws and International Regulations

 

Carolyn White, Executive Director, R&D Quality, Allergan/AbbVie 

Carolyn is the Executive Director of R&D Quality for Medical Devices with the RDQA organization. In this role, she and her team are responsible for the oversight of the quality aspects for design control and risk management throughout the development of the medical device lifecycle.  Carolyn joined Allergan/Abbvie in September 2015 in Core Team Leader role within the R&D Devices organization where she was responsible for leading cross-functional development teams ensuring successful delivery of high-quality product development programs and managing project plans.

Prior to joining Allergan/Abbvie, Carolyn held positions of increasing responsibility, most recently as Director, Quality Operations at Medtronic PLC, Santa Ana, where she was responsible for developing, implementing and driving the site’s strategic quality plan for the Coronary and Structural Heart business unit.  During her time at Medtronic, Carolyn also managed the Quality integration of two acquisitions and held positions in Manufacturing Engineering and Operations Management within their tissue valve manufacturing facility.

 

Program Manager: Susan Bain, OCRA 2021 President-Elect

 

Cost:

  • OCRA Members: $25
  • Non-Members: $100, includes 1-year OCRA membership
  • Government and Student Members: $10, with student/government ID
  • Non-Member Government and Student Rate: $45, includes 1-year OCRA members

Details

Date:
July 21
Time:
6:00 pm - 7:00 pm UTC-7
Cost:
$10 – $100
View Event Website

Venue

Webinar