FDAnews Announces: FDA Compliance Boot Camp 2014, April 7-11

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Get five days of hands-on, interactive training at FDA Compliance Bootcamp 2014.The course instructors have trained the FDA's own investigators and some are former FDA investigators themselves.

FDA Compliance Boot Camp 2014:
Validation, Data Security, Quality Risk Management, and Compliance Training
April 7 - 11, 2014 – Frederick, MD
FDA Compliance Bootcamp 2014

Imagine if it was possible to get inside the head of a working FDA inspector or receive the same training the inspector gets or knowing which problems face the most scrutiny all before the next inspection.        

FDA Compliance Boot Camp 2014 includes three courses: one based on the same computerized system validation and Part 11 training the FDA gives its own investigators, one on CAPA systems and one on risk management.

Know what to expect when the next inspector walks through the door, from what the agency trains its investigators to look for, to which problems face the most scrutiny, including how the FDA expects manufacturers to manage their computerized systems and electronic records.

Attendees will even discover which of their systems will be up for inspection first. And they will learn what's behind the FDA's new add-on "surveillance inspections" for Part 11 inspections and how the European Union's new Annex 11 affects their operations, no matter where they are.

Why risk a single noncompliance penalty? Attend Compliance Boot Camp 2014 and feel secure in knowing the next inspection will be a complete success. And it takes less than a week.        

Throughout the courses offered in the Boot Camp, attendees will discover:            

  •     What it's like to undergo an actual FDA inspection. Compliance Boot Camp's simulated inspection exercise is as close to the real thing as manufacturers are likely to get — until the day the investigators actually visit their facility            
  •     What FDA investigators are trained to look for ... which systems they inspect first ... which problems get the most scrutiny
  •     Self-auditing techniques to use before the investigators call            
  •     And so much more                    

All attendees will receive the ValidationVault[tm] Resource CD free with Boot Camp attendance.        

A $295 value, the Resource CD gives desktop access to a treasure trove of FDA laws, regulations and guidances, inspection protocols, warning letters and international guidelines.        

The CD has been designed by the Boot Camp instructors specifically for those involved in computerized systems validation, quality management, software development, or electronic records/signatures compliance. Included in the ValidationVault[tm] Resource CD are the latest versions of the FDA's Investigations Operation Manual, relevant Title 21 CFR regulations, a complete library of FDA guidance documents related to validation and Part 11, key ICH guidelines and much more.

Course Instructors

  •     Martin Browning, President, EduQuest
  •     Denise Dion, Vice President of Regulatory and Quality Services, EduQuest
  •     Janis V. Olson, Vice President of Regulatory and Quality Services, EduQuest

Conference Details
FDA Compliance Boot Camp 2014:
Validation, Data Security, Quality Risk Management, and Compliance Training
April 7 - 11, 2014 – Frederick, MD

Easy Ways to Register
Online: [http://www.fdanews.com/ComplianceBootcamp
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.

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Michelle Butler
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