FDA MAP
  • Home
  • Training
    • WORKSHOPS
    • WEBINARS
    • CUSTOM TRAINING
  • SERVICES
    • REGULATORY SERVICES
    • FDA AUDITING
    • QUALITY ASSURANCE
    • CLINICAL TRIAL SERVICES
  • News Releases
  • About Us
Newsletter - March 30, 2017
​
FDA Audit Processes to Change Dramatically in May  

The FDA’s Office of Regulatory Affairs (ORA), which is responsible for all audits conducted by FDA, is undergoing a major reorganization starting 17th May this year, which is expected to dramatically change how FDA audits. ORA will distribute its auditors into five specialized commodity-based groups, plus one group for clinical trial audits. Read More 

Major Data Integrity Violations Exposes Flaws in the Regulatory Process 

This week European Medicines Agency (EMA) announced suspension of the approval of 331 drugs due to gross data integrity violations at an Indian CRO. This is the third episode of its kind in the last 2 years and exposes a major defect in the regulatory review process in EU. Read More

Our Services

  • Workshops
  • Webinars
  • On-Demand Webinars
  • Custom training
  • Training Subscriptions
  • Corporate Registration
  • Certification Program
  • Smart Recruitment
  • Corporate Registration - Online Workshop​

Company

  • About Us​
  • Testimonials
  • Free Resources
  • Newsletter
  • Videos (Free Tutorials)

Support

  • Contact Us
  • Terms of Service
  • Privacy Policy
  • News Archive
Consultation Service
FDA Training Company
Copyright © 2022 FDAMap.com
Use of this Web site constitutes acceptance of the FDAMap Terms of Use and Privacy Policy.