- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
Have you ever wondered about the FDA strategies for scheduling inspections and pursuing compliance plans? This seminar 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 uses registration and listing data, these companies sometimes fail to address key issues in response to FDA 483s and Warning Letters and fail to manage inspections to reduce their overall risk. Here is your chance to better understand how FDA thinks and operates and what their key areas of focus and priority are from a former Compliance insider.Click to View the Pricing Plan
Registration and Listing regulatory requirements, process, and how FDA uses this data will be discussed. FDA strategic direction and how they reach decisions in developing inspection and compliance plans will be discussed.
• Registration and Listing process and requirements.
• FDA inspection planning activities
• Compliance strategies
WHO WILL BENEFIT
• VP’s and Directors in Regulatory Affairs
• VP’s and Directors in Quality Assurance
• Regulatory Affairs Managers and Professionals
• Quality Managers and 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.