FDA INSPECTIONS WITH XOOLI
Exploring the FDA’s Refuse to Accept Policy for FDA Regulated Companies from XOOLI
Now on Mobile Devices
By instituting a Refuse to Accept Policy, the Center for Devices and Radiological Health will be able to focus substantive review ONLY on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy will be reviewed more quickly.
WHAT YOU WILL LEARN
In this course you will learn the expectations of the FDA in regards to 510k submissions and by following the outlined principles you can minimize your risk of submission rejection and increase the potential for a speedy review and approval by the agency.
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
BASIC & INTERMEDIATE
- A complete overview of the FDA’s guidance on Refuse to Accept
- Best practices for pre-submission interaction
- A primer on the 510(K) Refuse to Accept Policies and Procedures, including;
- The 510(K) Checklist
- The FDA review Clock
- What to expect in a notification of acceptance
- The Acceptance Review Checklist
- Clear understanding of Traditional vs. Non-Traditional 510(K)s
- Regulatory Personnel
- Clinical Trial Physician / Doctor
- Manager to Senior Director / VP of;
- Regulatory Affairs
- Quality Assurance
- Clinical Research
- Data Management
- Data Monitoring
- Institutional Review Board
- IT Personnel
Extensive Research into the FDA’s Refuse to Accept Policy provides background, improves submissions and supplies imperative guidelines for success.
Utilizing a risk-based approach, this course provides context for the FDA’s new policy regarding 510(K) submissions, how to avoid immediate rejection and submission guidelines to better expedite the review process.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPS credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.
XOOLI is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform
Course Author Bio
Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences
Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.