PharmiWeb.com - Global Pharma News & Resources
09-Sep-2019 - 10-Sep-2019

Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2018/2019)

  • Location:
    • Venue to be announced shortly
    • Boston
    • MA
    • 02101
    • United States
  • View on a map

The objective of this two day ComplianceOnline seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance. Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organization and your vendors before the regulators find them for you. This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

 

Learning Objectives:

Upon completing this course participants should:

  • Assure your understanding of the fundamental causes of Data Integrity issues
  • Be able to identify these key elements
  • Understand how cGMP regulations impact Data Integrity issues
  • Understanding the various inspection approaches to monitor for Data Integrity
  • Learn how to determine the regulatory requirements required to assure Data Integrity
  • Understand the consequences of questionable data and how they may lead to seizures, import alerts, etc
 

Who Will Benefit:

Those that will benefit from this program include anyone involved in the incoming materials, manufacturing, laboratory and packaging process within a non-sterile/aseptic pharmaceutical environment.

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists