FDAnews Announces: FDA Data Integrity: From Data Creation to Long-Term Archive Workshop, Dec. 8-9, 2015
Falls Church, VA (PRWEB) October 29, 2015 -- FDA Data Integrity:
From Data Creation to Long-Term Archive
**Presented by Cerulean Associates LLC and FDAnews**
Dec. 8-9, 2015 – Raleigh, NC
http://www.fdanews.com/fdadataintegrity
FDA data integrity requirements are among the most strenuous that regulated industries have to comply with.
And the FDA is keeping pressure on those with data integrity shortcomings — issuing a growing number of warning letters every year for the last few years.
Simply put, to avoid citations, electronic records must be trustworthy and reliable across their entire data lifecycle — from initial data creation through long-term archival.
Compliantly managing essential data can be an overwhelming, even mind-boggling undertaking.
Thankfully, there's an expert with deep knowledge who can explain complex FDA data integrity regulations in simple 'what to do, how to do it' language.
Award-winning FDA compliance expert, author and Cerulean founder John Avellanet will be the workshop leader. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.
A former FDA and DOJ prosecutor calls Mr. Avellanet, “The best in the business. Period.”
After two days of 'total immersion' study, attendees will return to the office with increased understanding based on team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with John and fellow attendees.
During each of 10 workshop sessions, attendees will participate in interactive group projects… review case studies … draft practice business cases, plans and communications … and more.
They’ll also simulate investigative scenarios using real data from real inspections — and even determine whether or not warning letters should be issued!
Consider this. 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 manufacturers can expect to receive a warning letter.
Don't let things get to this point. Attend FDA Data Integrity: From Data Creation to Long-Term Archive in Raleigh on Dec. 8-9, 2015.
Meet the Speaker:
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.
Who Should Attend:
• Executive management
• Regulatory affairs
• Quality assurance/quality control
• Legal and compliance officers
• Clinical research directors
• Consultants/service providers
• CAPA specialists
• Compliance information managers
• GMP compliance officers
• GMP training managers
• Heads of internal audits
• QA documentation managers
• QA/QC managers and directors
• Quality systems managers
• Systems analysts
• Training personnel
Conference Details:
FDA Data Integrity:
From Data Creation to Long-Term Archive
**Presented by Cerulean Associates LLC and FDAnews**
Dec. 8-9, 2015 – Raleigh, NC
http://www.fdanews.com/fdadataintegrity
Tuition: $1,797
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.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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