fda’s-guidance-medical-device-recalls-2019

FDA’s Guidance: Medical Device Recalls 2019

Live Webinar

  • 180 minutes

Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.

Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration 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.

Join this session by expert speaker Angela Bazigos, where she will discuss that who can initiate a Medical Device Recall? And she will also discuss How to determine if you have a Medical Device Recall.

Session Highlights:

Session I – Determining and Initiating the need for a Recall

  • What is a Recall

  • Where and What Should Be Reported

  • Reports of Correction and Removal

Session II – Firm’s Responsibilities and action points

  • Firm’s Responsibilities for a Recall

  • Adverse Consequences or Risk to Health

  • Safety Alerts

  • A Firm’s Recall Communication

  • A Firm’s Recall Strategy

  • Firm’s Follow-up Responsibilities

  • Quality System Requirements

  • Things to Consider When Recalling Your Medical Device

  • Recall Status Reports

  • Recall Termination

Session III – FDA’s expectations and Enforcement Policy

  • FDA’s Enforcement Policy

  • FDA Expectations

  • FDA’s Role

  • Recall Classification

  • What can FDA do when a firm is reluctant to conduct a recall?

Why You Should Attend:

Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly van leads to seizure multiple seizures or other court action by the Food and Drug Administration. Effective Recalls, will minimize both the financial and PR issues for your firm, and will enable your firm to swiftly move to the phase of starting to re-build after an issue.

Who Should Attend:

  • Regulatory Affairs

  • Clinical Investigators/ Clinical Research

  • Biostatisticians

  • Institutional Review Boards

  • Data Monitors

  • Clinical Trial Physician / Doctor

  • Manager to Senior Director of

  • Quality Assurance

  • Data Management, Data Monitoring 


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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