Fremont, California (PressExposure) March 22, 2013 -- Description:
Ask any regulatory professional which the most agonizing moment of her life is, and the answer is almost certain to be,"FDA inspections", since it is the regulatory professional who is going to be held responsible for any lapse that the FDA inspectors may find. However, this need not always be so, because knowledge of how to prepare for an FDA inspection is a sure-shot way of avoiding penalties.
So, what does a regulatory professional need to know in order to avoid the butterflies in the stomach? She needs to have first-hand knowledge of what an FDA inspector can ask, and more important what the inspector cannot.
This webinar presents insights into precisely these aspects of an FDA inspection. It will take a look into the scope of an FDA inspection, the documents they can and cannot ask for, photographs and affidavits that are deemed permissible during an inspection, and so on. Attending this webinar will give participants the right knowledge of handling an FDA inspection. Participants will realize that an FDA inspection need not, after all, be the kind of horrific event it has been perceived to be.
This webinar will cover the following areas:
o How to prepare for an FDA inspection
o Development and contents of an SOP for FDA inspection
o Personnel training before inspection
o How to behave during an inspection
o Limitations of scope of inspection
o Response to investigation findings
o FDA guidance documents used by their inspectors
When:April 2, 10:00 AM PDT | 01:00 PM EDT
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. In this position, Jeff holds the critical portfolio of being responsible for oversight of corporate compliance with domestic and international regulations and preparation of submissions, and is the primary liaison point with regulatory agencies and notified bodies.
Performing such challenging tasks day in and day out has given Jeff deep knowledge of regulatory affairs, which he has imparted in the dozens of webinars he has presented in many areas dealing with regulatory compliance. Jeff received his Regulatory Affairs Certification in 1996.
o Executive/Senior Management
o Regulatory Management
o QA Management
o Quality system auditors
o Any personnel who may have direct interaction with FDA officials
Duration: 60 minutes
To enroll for this webinar, contact