FALLS CHURCH, Va., Sept. 16, 2019 /PRNewswire-PRWeb/ -- FDA Data Integrity For Device and Pharma Firms, and Their Suppliers **An interactive workshop presented by Cerulean Associates LLC and FDAnews** Oct. 21-22, 2019
Doubletree by Hilton Hotel Bethesda – Washington DC • Bethesda, MD
https://www.fdanews.com/fdadataintegrity
FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers starts in one week.
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:
Reminder: FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers starts in one week.
Dates and Location Oct. 21-22, 2019 Doubletree by Hilton Hotel Bethesda – Washington DC 8120 Wisconsin Avenue Bethesda, MD 20814 (301) 652-2000 Hotel Website: https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/index.html Room rate: $249 plus 13% tax Reservation Cut-off: Sept. 20, 2019
Webinar Details: FDA Data Integrity For Device and Pharma Firms, and Their Suppliers **An interactive workshop presented by Cerulean Associates LLC and FDAnews** Oct. 21-22, 2019 Doubletree by Hilton Hotel Bethesda – Washington DC • Bethesda, MD https://www.fdanews.com/fdadataintegrity
Tuition: Regular Pricing: $1,797 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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FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers starts in one week.
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."
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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 trails 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 your 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 your company
Reminder: FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers starts in one week.
Dates and Location Oct. 21-22, 2019 Doubletree by Hilton Hotel Bethesda – Washington DC 8120 Wisconsin Avenue Bethesda, MD 20814 (301) 652-2000 Hotel Website: https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/index.html Room rate: $249 plus 13% tax Reservation Cut-off: Sept. 20, 2019
Webinar Details: FDA Data Integrity For Device and Pharma Firms, and Their Suppliers **An interactive workshop presented by Cerulean Associates LLC and FDAnews** Oct. 21-22, 2019 Doubletree by Hilton Hotel Bethesda – Washington DC • Bethesda, MD https://www.fdanews.com/fdadataintegrity
Tuition: Regular Pricing: $1,797 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
