FDAnews Announces: Pre-Conference Workshop — Flawless FDA Inspection Handling and Response: A Hands-On Seminar for FDA-Regulated Companies, Oct. 22, 2014

In four hours, John Avellanet delivers proven, practical techniques for fast, flexible, flawless inspectional handling and response. Attendees will leave the session with a complete inspection SOP and an observation closure matrix, able to prove to an investigator they’re in a “state-of-control” and, if the worst happens, go from 483 observation to a coveted Untitled Letter without ever triggering a Warning Letter.

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9th Annual FDA Inspections Summit

9th Annual FDA Inspections Summit

Falls Church, VA (PRWEB) August 21, 2014

Flawless FDA Inspection Handling and Response:
A Hands-On Seminar for FDA-Regulated Companies
Pre-Conference Workshop on Oct. 22, 2014
9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD
http://www.fdanews.com/FlawlessFDAInspectionHandling

Come to Washington in October for an afternoon of inspection tips and tricks, conducted by an acknowledged master of inspections.

In four hours, John Avellanet delivers proven, practical techniques for fast, flexible, flawless inspectional handling and response. Attendees will leave the session with a complete inspection SOP and an observation closure matrix, able to prove to an investigator they’re in a “state-of-control” and, if the worst happens, go from 483 observation to a coveted Untitled Letter without ever triggering a Warning Letter.

John Avellannet, Managing Director and Principal, Cerulean Associates LLC, specializes in lean FDA compliance and FDA/ICH Quality by Design. Seats are limited, register today.

Want specifics? Here are but a few:

  •     Critical inspection preparation techniques to take
  •     Hidden tactics FDA investigators use to test controls
  •     How to speed the inspection up and move the investigator along
  •     Key elements of a regulatory inspection-handling SOP
  •     Writing an inspection response that cuts Warning Letter likelihood
  •     Red flags FDA looks for in your inspection response

Attendees will receive handouts worth the registration fee by themselves, including:

  •     An inspection SOP ready for immediate implementation
  •     Three inspection-handling and response checklists ready to use
  •     An observation-closure matrix, to speed manufacturers away from post-inspection woes
  •     And more besides

Flawless FDA Inspection Handling and Response is a pre-conference seminar presented in conjunction with the 9th Annual FDA Inspections Summit. Attend either or both! For full pre-conference and conference information and registration, click here.

Conference Details:
Flawless FDA Inspection Handling and Response:
A Hands-On Seminar for FDA-Regulated Companies
Pre-Conference Workshop on Oct. 22, 2014
9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD
http://www.fdanews.com/FlawlessFDAInspectionHandling

Tuition:
Early Bird Registration (until Sept. 19, 2014):
Pre-Conference Only: $537
Complete Summit $1,797

Regular Registration (Sept. 20, 2014 on):
Pre-Conference Only: $597
Complete Summit $1,997
Additional pricing options are available online.

Easy Ways to Register:
Online: http://www.fdanews.com/FlawlessFDAInspectionHandling
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.