MEDICAL DEVICES WITH XOOLI
FDA Guidance on Medical Device Recalls for FDA Regulated Companies Metrics from Morf Media, USA
Now on Mobile Devices
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the FDA. Manufacturers and distributors usually voluntarily recall devices to protect public health and well-being. A request by the FDA that a firm recall a device is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the device that is to be recalled.
WHAT YOU WILL LEARN
This course will train you in every aspect of the device recall process. Failure to properly recall a product can lead to seizure or other court actions by the FDA. Training in effective recalls will minimize both financial and PR issues for your firm and will enable your firm to swiftly re-build after an issue.
BASIC & FUNDAMENTAL
- What is a medical device recall and how to determine if you have one
- Who can initiate a Medical Device Recall?
- A picture of firm responsibilities: where and what should be reported
- The FDA’s Enforcement Policy
- What can the FDA do when a firm is reluctant to conduct a recall?
- An overview of adverse consequences or risks to health
- Comprehensive insight on effective recall communication and strategy
- Training in follow-up responsibilities
- Quality System Requirements
- An overview of recall status reports and classification
- The exact procedure of a recall termination
- Clinical Trial Physician / Doctor
- Clinical investigators
- Manager to Senior Director of;
- Regulatory Affairs
- Quality Assurance
- Clinical Research
- Data Management
- Data Monitoring
- Institutional Review Board
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Comprehensive training in Medical Device Recalls provides safety, improves recall processes, and reduces negative agency actions.
Delivers expert training in how to effectively coordinate the medical device recall process and reduce financial losses and negative PR.
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.
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.