FDAnews Announces: Data Integrity: The Key to FDA and GMP Compliance, July 14-15, 2016, Arlington, VA

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Join award-winning FDA compliance expert, author and Cerulean founder John Avellanet for Data Integrity: The Key to FDA and GMP Compliance workshop. After two days of 'total immersion' study, attendees will return to their offices with a better understanding through team exercises and case studies and honest no-holds-barred discussions with John and their fellow attendees.

Data Integrity:
The Key to FDA and GMP Compliance
**Presented by FDAnews and Cerulean Associates LLC **
July 14-15, 2016 – Arlington, VA
http://www.fdanews.com/fdadataintegrity

Data integrity problems are among the most cited issues in GMP warning letters.

The three main areas of concern include:

  • Lack of adequate controls
  • Lack of staff competence
  • Lack of adequate root cause analysis

These issues are often the result of insufficiently controlled processes, poor documentation practices, lack of quality oversight or professional ignorance.

With the increased scrutiny on data integrity establishing internal competency and assessment programs is essential.

Join award-winning FDA compliance expert, author and Cerulean founder John Avellanet for Data Integrity: The Key to FDA and GMP Compliance workshop. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.

During the 10 workshop sessions, attendees will:

  • Identify likely risks and select the most appropriate controls
  • Review case study validation tests to see if data integrity is actually being verified
  • Draft a memo to be sent out by the senior team to all company employees about good data integrity
  • Draft a business case and plan for implementing a data integrity control framework
  • and more…

Attendees will also simulate investigative scenarios using real data from real inspections — and even determine whether or not warning letters should be issued!

After two days of 'total immersion' study, return to the office with a better understanding through team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with John and the other attendees.

Meet the Presenter:
John Avellanet, Founder Cerulean Associates LLC

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.

Conference Details
Data Integrity:
The Key to FDA and GMP Compliance
**Presented by FDAnews and Cerulean Associates LLC **
July 14-15, 2016 – Arlington, VA
http://www.fdanews.com/fdadataintegrity

Tuition: $1,797
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/fdadataintegrity
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
FDANEWS
+1 (703) 538-7665
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