Overview

Good Documentation Practice (GDocP) are the standards in the regulated industries by which documents are created and maintained.

Because GDocP is aligned with GxP/GMP, documentation is a critical tool for ensuring GxP/GMP compliance.

Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death.

Why Should you attend

In the regulated industries which must be GxP/GMP compliant, document control is the cornerstone of the quality system.

Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Documentation is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.

Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.

Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.

Learn how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit

Only controlled documents should be used to perform work. But not all documents need to be controlled.

In this webinar, describe the connection between GxP/GMP and document control. We will identify controlled documents. We will also describe documents of Quality Management System.

Details of document control procedures and the role of Quality Assurance in the documentation systems will be described. We will also review document management systems, as well as the change control procedure and how it should be used in GxP/GMP environment.

Webinar Takeaway

  • GxP/GMP and Documentation
  • Purpose of Document Control
  • Controlled Documents – Types, Identification
  • Role of QA in Document Control
  • Document Control Procedures
  • Document Management System
  • Measuring Success of Document Control System
  • Change Control Procedure

Learning Objectives

In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.

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

Auditors pay particular attention to documentation to make sure that it complies with GMP and GDocP. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.

Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.

Who will Benefit

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

Industries who can attend

This 90-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 90-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.