Tools and Techniques to Ensure Successful Outcomes in Device GCP Audits

The FDA has implemented stricter regulatory requirements for medical device clinical studies and are now requiring vast amounts of clinical data before a device can be approved for market. Good Clinical Practice (GCP) audits are a critical and complex process that provides device manufacturers with assurance that all parties are operating in compliance with FDA requirements. Audits of clinical SOPs and data can serve as essential preparation for both the manufacturer and clinical investigators prior to a regulatory inspection and provide all stakeholders with greater confidence in the study conduct and research findings. The following presentation will provide attendees with an overview on strategically planning, preparing for and organizing internal and sponsor GCP inspections and specifically cover:

  • Various types and levels of auditing structures
  • Knowing when to conduct an audit and which teams/personnel to involve
  • Defining and incorporating applicable auditing regulatory standards

Attendee Profile
Professionals that would find this recording most beneficial will be those involved in medical device companies with the following job titles:

  • Quality Assurance/Systems
  • Clinical Affairs & Clinical Operations
  • Regulatory
  • Compliance
 

Becki Nowatzke
Director of Regulatory Compliance & Clinical Research
WENZEL SPINE, INC.

Beckinam is the Director of Regulatory Compliance & Clinical Research for Wenzel Spine. She is an accomplished Quality & Regulatory Affairs professional with over 17 years of experience across the Biotechnology, Pharmaceutical, CRO, and Medical Device industries. Beckinam has managed GxP Quality Assurance Compliance processes, Quality Improvement initiatives, and Quality System implementations in compliance with 21 CFR Part 820 and ISO 13485. She also has extensive experience managing medical device regulatory processes and compliance systems. Beckinam has held positions with Amgen, Biomimetic Therapeutics, CEDRA Clinical Research (now WCT) and LDR Spine (now part of Zimmer Biomet). She earned her B.S. in Biology from Loyola Marymount University and her M.S. in Regulatory Sciences from the University of Southern California.

 

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com

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