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

Event Details

Time: July 10, 2014 from 9am to 6pm
Location: Courtyard Boston Logan Airport
Street: Boston, MA
City/Town: Boston, MA
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. The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions.

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. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

DATE, VENUE & PRICE:

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

Venue: Courtyard Boston Logan Airport

Venue Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA

Price: $1,295.00

Until May 31, Early Bird Price: $1,295.00

From June 01 to July 08, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com