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2-day In-person Seminar on FDA Inspections: Before, during and after at San Diego, CA

Event Details

2-day In-person Seminar on FDA Inspections: Before, during and after at San Diego, CA

Time: June 4, 2015 from 9am to 5pm
Location: DoubleTree by Hilton Hotel San Diego Downtown
Street: 1646 Front Street, San Diego, California, 92101, USA
City/Town: San Diego
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Mar 10, 2015

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Event Description

Overview:

FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. 

Why should you attend?

"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers.

Areas Covered in the Session:
  • FDA legal authority
  • Types of inspections
  • FDA investigator training
  • FDA's written procedures, policy and operations guide
  • Industry inspection protocol
  • What to do and not do during an inspection
  • Form FDA 483 response
  • Warning Letter response
  • Enforcement
  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing

Instructor Profile:

Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. 

Location: San Diego, CA        Date: June 4th & 5th, 2015        Time: 9:00AM - 5:00PM 
Venue: DoubleTree by Hilton Hotel San Diego Downtown

Venue Address: 1646 Front Street, San Diego, California, 92101, USA

Price: $1,295.00

 

Registration Details:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 1-800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/FDA-Inspections-Before-During-and-After

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