FDAnews Announces -- FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers Workshop March 17-18, 2020 - Philadelphia, PA

Saturday, December 21, 2019 Press Release
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FDA is keeping pressure on device and drug firms with data integrity shortcomings.

FALLS CHURCH, Va., Dec. 20, 2019 /PRNewswire-PRWeb/ -- FDA Data Integrity For Device and Pharma Firms, and Their Suppliers An interactive workshop presented by Cerulean Associates LLC and FDAnews March 17-18, 2020 Doubletree Hotel Philadelphia Center City • Philadelphia, PA https://www.fdanews.com/fdadataintegrity

Early Bird Savings: Register by Feb. 18 and Save $200

FDA gives simple instructions to its investigators: "If initial findings indicate the firm's electronic records may not be trustworthy and reliable, or when electronic recordkeeping systems inhibit meaningful FDA inspection, a more detailed evaluation may be warranted."

That's the polite way of saying this is when one can expect to receive a Form 483 or warning letter.

With 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 the interactive workshop: Data Integrity for Device and Pharma Firms, and Their Suppliers. 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 *Work to review audit trials and case study situations to determine the data integrity failures *Review case study validation tests to see if data integrity is actually being verified *See hundreds of questions and audit points to consider for internal and supplier audits *Understand what departments need to be involved – who should take a leading role, how, and why *Draft a personal business case and plan for implementing a data integrity control framework at ones company

After two days of 'total immersion' study, one 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.

Conference Details: FDA Data Integrity For Device and Pharma Firms, and Their Suppliers An interactive workshop presented by Cerulean Associates LLC and FDAnews March 17-18, 2020 Doubletree Hotel Philadelphia Center City • Philadelphia, PA https://www.fdanews.com/fdadataintegrity

Tuition: Early Bird Pricing: $1,597 (available until Feb. 18, 2020) Regular Pricing: $1,797 (after Feb. 18, 2020) Significant team discounts are available.

Easy Ways to Register: Online: https://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.

 

SOURCE FDAnews



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