Navigation Links
FDAnews Announces — 1 Week Until FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers Workshop March 17-18, 2020, Philadelphia, PA
Date:3/10/2020

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/fdadataintegrity

FDA 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/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.

Read the full story at https://www.prweb.com/releases/fdanews_announces_1_week_until_fda_data_integrity_for_device_and_pharma_firms_and_their_suppliers_workshop_march_17_18_2020_philadelphia_pa/prweb16944391.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Announces — Healthcare Innovation and FDA Regulation: Former FDA Commissioner Explains Growing Opportunities for Biomedical Products Webinar, Mar. 19, 2020
2. FDAnews Announces — Pharmacy Compounding Regulation: FDA’s Latest Guidance, Compliance & Enforcement Activities Webinar, Feb. 18, 2020
3. FDAnews/CenterWatch Announces — Real World Evidence and Data: A Tufts Study of 30 Pharma Companies Webinar January 23, 2020
4. FDAnews Announces — Postmarket Problems for Medical Devices: The Path to Resolution Workshop Feb. 19-20, 2020 - Atlanta, GA
5. FDAnews Announces — Understanding UDI in EU Device Regulations Webinar, Nov. 21, 2019
6. FDAnews Announces — 1 Week Until Conducting Advanced Root Cause Analysis and CAPA Investigations: Critical Thinking Skills and Innovative Techniques Nov. 13-14
7. FDAnews Announces — Early Bird Pricing Ends on Nov. 12, Building a World-Class Advertising and Promotion Review Program Dec. 10-11, 2019 Miami, FL
8. FDAnews Announces — Labeling for Prescription Drugs, Biologics and Combination Products:Complying with FDA’s Most Recent IFU Guidance Webinar, Oct. 29, 2019
9. FDAnews Announces — Medical Device Nonconforming Audit Findings: Corrective Action That’s Right for Your Company Webinar, Oct. 15, 2019
10. FDAnews Announces — 510(k) Change Analysis: Make the Guidance Documents Work for You Webinar, August 22, 2019
11. FDAnews Announces — Early Bird Pricing Ends on Aug. 9, EU-Medical Device Regulation/ In Vitro Diagnostics Regulation Compliance Workshops Sept. 10-12, 2019
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/5/2020)... ... August 05, 2020 , ... ... (SEL) program, has been named to the inaugural list of Best Digital Tools ... , This recognition honors electronic resources that provide enhanced learning and curriculum development ...
(Date:8/5/2020)... (PRWEB) , ... August 05, 2020 , ... ... to loss of consciousness, seizures, prolonged length of hospital stay, or even death. ... study of insulin-treated patients with Type 2 diabetes to see if the use ...
(Date:8/5/2020)... ... August 05, 2020 , ... Today, YPO Africa ... leading trade and investment platform for Africa, announced that they have entered into a ... and Invest Africa to support each other in their African impact efforts, with an ...
(Date:8/3/2020)... ... August 03, 2020 , ... Evolution ... Suite360:Mental Health and Prevention program district-wide, developed to help students navigate a range ... , Florida schools and districts must provide their students with preventative lessons after ...
(Date:7/31/2020)... ... July 31, 2020 , ... ... Clinical Research’s internal medicine site in Savannah, GA. Visitors included Moncef Slaoui, ... In May, the federal government announced the OWS program to accelerate the development, ...
Breaking Medicine News(10 mins):
(Date:8/5/2020)... ... 04, 2020 , ... The Pulmonary Wellness Foundation (PWF), a New York City-based ... nearly three decades, today announced the launch of the nation’s first online COVID Rehabilitation ... off Sunday, August 2 and meets on Wednesday and Sunday evenings at 7 pm ...
(Date:8/5/2020)... ... August 04, 2020 , ... ... services vital to their health and quality of life unless Congress and the ... American Speech-Language-Hearing Association (ASHA) warns today. , At issue is CMS’s ...
(Date:8/3/2020)... ... 2020 , ... Gottlieb, a leader in end-to-end revenue cycle ... new Vice President of Client Services. Kopronica brings over 25 years of Emergency ... teams and delivering client-focused solutions. In this role, Kopronica will lead Gottlieb’s national ...
Breaking Medicine Technology: