2-Day Virtual Seminar

GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

BY: Eleonora Babayants, Founder and President, Galaxy Consulting

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Coming soon.. Please contact customer care for new schedule
  • Course Description
  • Agenda
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In this Virtual Seminar, you will learn the framework of GxP/GMP regulations, quality management system, quality audit, and CAPA.

You will also learn the connection between GxP/GMP and document control, details of document control procedures and the role of Quality Assurance in the documentation systems.

This Virtual Seminar also includes very important GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. There is also a review of change control procedure and how it should be used in GxP/GMP environment.

GMP regulations require that all documentation be issued, managed, and controlled using a document management system. This Virtual Seminar also includes information about few major document management systems.

Learning Objectives:
  • What is quality management system? Are you ready for the audit?
  • Learn about GxP/GMP regulations and how they affect quality management system and quality audit. Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.
  • Do you know how to properly manage and control your documentation so that your organization can pass GMP audit? Are your IT systems GxP/GMP compliant?
  • Learn how to manage and control documents as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit.
Areas Covered:
  • GxP/GMP, its Role, and its Consequences for the Regulated Industries
  • Quality Management System
  • Quality Audit
  • What is CAPA?
  • CAPA Concepts
  • CAPA Procedure
  • GxP/GMP and Documentation
  • Purpose of Document Control
  • Controlled Documents - Types, Identification
  • Role of QA in Document Control
  • Document Control Procedures
  • GxP/GMP Requirements for IT systems in regulated industries
  • IT Systems Validation
  • GxP/GMP and Change Control Procedure
  • Change Control Procedure Steps
  • Change Control Procedure for Document Control
  • IT Change Control Procedure Steps
  • Document Management Systems
    • SharePoint
    • Arena
    • TeamSite
    • OpenText
    • Oracle UCM
    • SDL Tridion
    • Open Source Systems
Who will Benefit:
  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT/Software
  • Manufacturing
  • Clinical
  • Lab
Topic Background:

GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.

Quality management system ensures that a product is safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance, quality control, and quality improvement.

Quality audit is the process of systematic inspection of quality management system which is carried out by an internal or external auditor or an audit team. It is an important part of organization's quality management system and is the major part of GxP/GMP regulations.

CAPA - Corrective and Preventive Action plan. It is required for FDA compliance in case of specification situations or other deviations.

Documentation is a critical tool for ensuring GxP/GMP compliance.

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.

Day 01(9:00 AM - 4:30 PM PDT)
  • Introduction and objectives
  • 9:30 AM – 11:00 AM: Session 1: GxP/GMP Framework
    • Seminar objectives review, expectations and scope.
    • GxP/GMP, its Role, and its Consequences for the Regulated Industries
  • 11:00 AM - 12:30 PM: Session 2: Quality Management System and Quality Audit
    • Quality Management System
    • Quality Audit
  • 12:30 PM - 1:30 PM Lunch
  • 1:30 PM - 3:00 PM: Session 3: CAPA
    • What is CAPA?
    • CAPA Concepts
    • CAPA Procedure
  • 3:00 PM - 4:30 PM: Session 4: GxP/GMP and Documentation
    • GxP/GMP and Documentation
    • Purpose of Document Control
    • Controlled Documents – Types, Identification
    • Role of QA in Document Control
    • Document Control Procedures
Day 02(9:00 AM - 4:30 PM PDT)
  • 9:30 AM - 11:00 AM: Session 1: GxP/GMP and IT Systems
    • GxP/GMP Requirements for IT systems in regulated industries
    • IT Systems Validation
  • 11:00 AM - 12:30 PM: Session 2: Change Control Procedure
    • GxP/GMP and Change Control Procedure
    • Change Control Procedure Steps
    • Change Control Procedure for Document Control
  • 12:30 PM - 1:30 PM Lunch
  • 1:30 PM - 3:00 PM: Session 3: Change Control Procedure for Information Technology (IT) Systems
    • IT Change Control Procedure Steps
  • 3:00 PM - 4:30 PM: Session 4: Document Management Systems
    • SharePoint
    • Arena
    • TeamSite
    • OpenText
    • Oracle UCM
    • SDL Tridion
    • Open Source Systems
Eleonora Babayants
Eleonora Babayants Founder and President, Galaxy Consulting

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

Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.

Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.

Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.

Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

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