FALLS CHURCH, VA. (PRWEB) MARCH 10, 2020
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/fdadataintegrityFDA Data Integrity: For Device and Pharma Firms, and Their Suppliers starts in one week.
The FDA hit four device firms in August for data integrity issues. They are increasingly scrutinizing pharma contract manufacturing organization (CMO) and contract research organization (CRO) data integrity control.
Currently, 35% of the FDA’s pre-approval inspection manual for investigators focuses on data integrity. It’s being factored into inspections of device firms’ complaint records, final testing and design control specifications.
With this increased pressure on data integrity, establishing internal competency and assessment programs is essential.
Join an award-winning FDA compliance expert, author and Cerulean founder John Avellanet at Data Integrity for Device and Pharma Firms, and Their Suppliers interactive hands-on workshop:
Act as an FDA investigator to find the data integrity controls the FDA expects to see during an inspection
Review the data integrity controls that companies have in place for their suppliers and determine if a warning letter can be avoided
Recognize likely compliance risks in case studies and select the most appropriate controls for each situation
Identify three compelling reasons for your company to adopt data integrity controls
Determine if data integrity is being verified
Map sample data flows from cGCP and cGMP case studies
Write a communication about good data integrity practices to lower workload inefficiencies and encourage self-compliance
Outline a sample set of data integrity controls and auditing plans
Draft a business case and prioritized plan for implementing a data integrity control framework at your company
Return to one’s office equipped to help oneself, the team and the entire company stay complaint.
Reminder: FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers starts in one week.
March 17-18, 2020
Doubletree By Hilton Hotel Philadelphia Center City
237 South Broad Street
Philadelphia, PA 19107
215.893.1600
Hotel Website: https://doubletree3.hilton.com/en/hotels/pennsylvania/doubletree-by-hilton-hotel-philadelphia-center-city-PHLBLDT/index.html
Room rate: $169 plus 16.37% tax
Reservation Cut-off: Feb. 16, 2020
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/fdadataintegrityTuition:
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
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