2-day In-person Seminar on Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions at Minneapolis

Event Details

Time: June 5, 2014 at 9am to June 6, 2014 at 6pm
Location: WILL BE ANNOUNCED SOON
Street: Minneapolis, MN
City/Town: Minneapolis
Website or Map: http://bit.ly/1lZNFJO
Phone: 18004479407
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: May 9, 2014

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Event Description

Overview:

FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or recalls or consent decrees. So you can look at the number of inspections as one indicator of how aggressive FDA is being regarding enforcement.

Why should you attend?

Address different types of Warning Letters
Understanding FDA's enforcement strategy and what it means to your firm
Understanding how auditors think and their expectations
Being prepared to receive regulatory inspections
Recognizing when inspectional findings or events indicate potential regulatory actions
When to take or not immediate action during an inspection

Who Will Benefit:

Individuals who come in contact with regulatory inspectors
Auditors
Compliance/Regulatory affairs professionals
QA/QC professionals
Senior management executives (CEO, COO, CFO, etc.)
Manufacturing managers, supervisors & personnel
Project Managers
Regulatory Affairs Management
Regulatory Affairs Specialist

About Speaker:

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.

DATE, VENUE & PRICE:

Location1: Location: Minneapolis Date: June 5th & 6th 2014 Time: 9 AM to 6 PM CDT

Venue: WILL BE ANNOUNCED SOON

Location2: Location: Boston Date: July 10th & 11th 2014 Time: 9 AM to 6 PM EDT

Price: $1,295.00

Until April 30, Early Bird Price: $1,295.00

From May 01 to June 03, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com