- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
FDA 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 (FDA). 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.
Recalls may be undertaken voluntarily and at any time by manufacturers and distributors, at the request of the FDA or by a mandatory recall order from FDA. Recall requests and orders by the FDA are reserved for urgent situations and are to be directed to the firm that has primary responsibility for the manufacture and marketing of the device that is to be recalled.
why should you attend
Recalling medical devices that present a hazard to consumers supports public health safety and protects companies from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly can lead to seizure actions by the FDA or other court actions. Effective Recalls will minimize both the financial and public relations issues for your company and will enable you to move beyond the effects of a recall much more quickly.Click to View the Pricing Plan
• What is a Recall and how to determine if you have one?
• Things to Consider When Recalling Your Medical Device
• Adverse Consequences or Risk to Health
• Who can initiate a Medical Device Recall?
• Where and What Should Be Reported?
• Reports of Corrections and Removals
• Company’s Responsibilities for a Recall
• Company’s Recall Communications, Strategy and follow-up responsibilities
• Quality Control Program
• Recall List
• Recall Status Reports
• Recall Termination
• FDA Compliance policy guide’s
• FDA’s Role and Expectations
• What can FDA do when a firm is reluctant to conduct a recall?
• Safety Risk Management
• How to identify, initiate, and manage a recall action effectively
• What FDA requires for recall reporting
• How FDA classifies and monitors recalls
• What authority FDA can use to force a recall and ensure it is managed effectively
WHO WILL BENEFIT
• Regulatory Affairs Managers / Senior Directors
• Quality Assurance Managers / Senior Directors
• Clinical Research Managers / Senior Directors
• Data Management Personnel
• Data Monitoring Personnel
• Clinical Trial Physicians
• Institutional Review Boards
Larry Spears has deep regulatory expertise from over 35 years' experience in government and consulting. This includes investigations, compliance and regulatory roles with FDA including senior compliance leadership positions in the CDRH Office of Compliance, as a consultant with a large life sciences consulting firm and as an independent consultant. Mr. Spears provides global regulatory strategy consultation to Life Science companies primarily in medical devices/diagnostics and pharmaceuticals with a focus on quality systems gap assessments, FDA mock inspections, quality system development and planning, and remediation for FDA inspection findings including, CAPA and complaints, design controls, supplier controls, production management, and trainingView all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.