ComplianceOnline

Challenges for the RA Professional, and How to Address Them

Instructor: Jeff Kasoff
Product ID: 700785
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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This webinar presents the most challenging compliance issues faced by companies, and sets forth methods to assure compliance.

Description

This webinar also sets forth the specific challenges experienced by RA in such an environment, and provides some solutions for how to overcome them.

It can be challenging to be in the Regulatory Affairs profession: your department has no revenue and is often considered no more than a cost center; you’re in the background, and when you’re not, it means there’s a serious problem. Companies whose operation is under the jurisdiction of the Food and Drug Administration are faced with a myriad of regulations with which to comply. How does a company know which requirements require the most attention? This webinar presents the most challenging compliance issues faced by companies, and sets forth methods to assure compliance. It’s doubly challenging to be an RA professional in a small or Startup Company. This webinar also sets forth the specific challenges experienced by RA in such an environment, and provides some solutions for how to overcome them.

Areas Covered in the seminar:

  • Classification of compliance responsibilities.
  • Which subsystems are the most difficult to bring into compliance?
  • In what areas have these subsystems been found to be out of compliance?
  • How are these subsystems interrelated?
  • Procedures, processes, or documentation to put in place to facilitate compliance.
  • Discussion of the nature of the small/startup company.
  • Perception of Regulatory Affairs in the small/startup company, and how to change that perception.
  • How to develop a quality system in a small/startup company?
  • How to assure ongoing compliance with a minimum of resources?

Who will benefit:

This webinar will provide valuable assistance to individuals responsible for corporate compliance with FDA regulations. The employees who will benefit include:

  • Top Management
  • Regulatory Management
  • Quality Management
  • Consultants
  • Regulatory Specialists
  • Documentation Managers

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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