Good Documentation Practice (GDocP) for FDA Regulated Industries

In this webinar, we will describe the connection between GxP/GMP, GDocP and document control.  We will also describe documents of a Quality Management System, and attendees will learn how to secure, manage and govern their documentation in compliance with GxP/GMP and GDocP requirements and be able to pass the Quality audit.

Eleonora Babayants
Instructor:
Eleonora Babayants
Date:
Thursday, April 16, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502991

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
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Overview:

GxP/GMP and 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Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death. Only controlled documents should be used to perform work. But not all documents need to be controlled.

In this webinar, we will describe the connection between GxP/GMP, GDocP 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.

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 and GDocP requirements, it must have a document control system in place. Learn how to manage and control documents in compliance with GxP/GMP and GDocP requirements and be able to pass quality audit.

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

Areas Covered in the Session:

  • GxP/GMP/GDocP 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

Who Will Benefit:
  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT


Speaker Profile
Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.

Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users' requirements.

She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.


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