Why is FDA at my facility, and what do I do during an inspection 2017

Event Details

Time: April 6, 2017 at 9am to April 7, 2017 at 6pm
Location: Baltimore, MD
Street: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090
City/Town: Baltimore, MD
Website or Map: http://www.globalcompliancepa…
Phone: 800-447-9407
Event Type: why, is, fda, at, my, facility, and, what, do, i, during, an, inspection, 2017
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Mar 2, 2017

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Event Description

Course "Why is FDA at my facility, and what do I do during an inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Location: Baltimore, MD Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport

Address: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until February 28, Early Bird Price: $1,295.00 from March 01 to April 04, Regular Price: $1,495.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com