Overview

There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.

Data security is the high priority in any organization but especially in a regulated industry.

Companies need to safeguard against every possible vulnerability across their entire infrastructure. In order to successfully safeguard data, data governance needs to be implemented.

Crisis preparedness is the high priority in any organization but especially in a regulated industry.

In this webinar, we will review GMP requirements for IT systems. We will review data security and data governance procedures and how to implement them.

You will also learn how to implement data security, e-discovery and crisis preparedness.

Why Should you attend

In the regulated environment which must be GxP/GMP compliant, data integrity is extremely important. Companies need to prevent data breaches from happening.

Data is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Data provides the route for auditors to assess the overall quality of operations within a company and the final product.

In order to maintain data in GxP/GMP compliant manner, data security procedures should be developed and implemented.

It is imperative to secure data, prepare for e-discovery, and be ready if crisis strikes.

Learn how to secure, manage and govern data as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit.

Learn how to ensure that IT systems are in compliance with GxP/GMP requirements and how to prepare for e-discovery and crisis

key learning objectives

Learn how to secure, manage and govern data as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit.

Learn how to ensure that IT systems are in compliance with GxP/GMP requirements and how to prepare for e-discovery and crisis.

Learn how to implement data security, e-discovery and crisis preparedness.

Webinar Takeaway

  • GxP/GMP Requirements for Information Technology
  • IT Systems Validation
  • Information Governance
  • Data Security
  • E-Discovery
  • Crisis Preparedness 

Who will Benefit

  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT 

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Faculty Eleonora Babayants


Galaxy Consulting Founder and President. She worked with quality assurance and compliance officers to develop and execute compliance has many years of GxP/GMP hands-on experience in regulated industries. strategies and programs. She participated in the implementation of compliance requirements.

Faculty Eleonora Babayants

Choose a Purchase Options

$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.