1 Hour Video | Becki Nowatzke, LDR Spine USA, Inc.
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 provides 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
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Quality Assurance/Systems
- Clinical Affairs & Clinical Operations
LDR Spine USA, Inc.
Becki Nowatzke, Quality Manager, LDR Spine USA, Inc.
Becki is an experienced Quality & Regulatory Affairs Professional with over twelve years of industry experience. She currently serves as the Quality Manager for LDR Spine USA, where she’s responsible for the daily management and continuous improvement of the quality system. Becki received her MS of Regulatory Sciences degree from USC and has expertise in GLP, GCP, GMP, drug and device FDA regulations.