FDAnews Announces -- FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers Workshop Oct. 21-22, 2019 Bethesda, MD

FDA is keeping pressure on device and drug firms with data integrity shortcomings.

News provided by

FDAnews

Jul 10, 2019, 00:00 ET

FALLS CHURCH, Va., July 10, 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

Early Bird Savings: Register by Sept. 23 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 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

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.

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:
Early Bird Pricing: $1,597 (available until April 9, 2019)
Regular Pricing: $1,797 (after April 9, 2019)
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

Related Links

https://www.fdanews.com