The Key to FDA and GMP Compliance, Dec. 5-6, 2017, Arlington, VA

Data Integrity Dec 2017

Data Integrity Dec 2017

Past News Releases


Data Integrity:
The Key to FDA and GMP Compliance
** Presented by FDAnews and Cerulean Associates LLC **
Dec. 5-6, 2017 – Arlington, VA

Consider this situation. The FDA gives simple instructions to its investigators: “If initial findings indicate the firm’s electronic records may not be trustworthy and reliable … a more detailed evaluation may be warranted.”

That's the polite way of saying this is when drug or devicemakers can expect to receive a warning letter.

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

After two days of 'total immersion' study, attendees will return to their office with increased understanding based on team exercises and case studies with informative, detailed explanations and honest no-holds-barred discussions with John Avellanet and fellow 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 **
Dec. 5-6, 2017 – Arlington, VA

Early Bird Pricing: $1,597 (available until Nov. 3, 2017)
Regular Pricing: $1,797 (after Nov. 3, 2017)
Significant team discounts are available.

Easy Ways to Register
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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