- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looking for? This webinar will provide clarity around those issues from a compliance expert with over 30 years’ experience in inspection and compliance management.
why should you attend
Many companies do not know what they don’t know when it comes to dealing with the FDA. By not understanding how FDA looks at CAPA corrective action and complaint problems, these companies oftentimes fail to manage inspections to reduce the risk of adverse findings. After the inspection, they fail to address key issues in response to fda 483s and Warning Letters. Here is your chance to better understand how FDA thinks and operates in managing these key inspection systems from a former medical device compliance insider.Click to View the Pricing Plan
CAPAs and complaints are key focus areas having GMP guidelines and this webinar will review the ins and outs of how to manage these systems and effectively address questions FDA will likely raise during inspections.
• Why CAPAs and complaints are so important to FDA
• How to be prepared for an FDA inspection of these areas
• How FDA uses data from inspections
• How to avoid or reduce risk in managing product experience data of this sort
WHO WILL BENEFIT
• VP’s in Quality Assurance
• Directors in Quality Assurance
• Quality Managers
• Quality Professionals
• Small Business Owners
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.