ComplianceOnline

In this 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 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 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.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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.

There are also 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.

Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.

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Day 01(9:00 AM - 4:30 PM)
  • 9:00 AM - 9:30 AM: Registration, Meet & Greet.
  • 9:30 AM – 11:00 AM: Session 1: GxP/GMP Framework (90 Mins)
    • 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 (90 Mins)
    • Quality Management System
    • Quality Audit
  • 12:30 PM - 1:30 PM Lunch
  • 1:30 PM - 3:00 PM: Session 3: CAPA (90 Mins)
    • What is CAPA?
    • CAPA Concepts
    • CAPA Procedure
  • 3:00 PM - 4:30 PM: Session 4: GxP/GMP and Documentation (90 Mins)
    • 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)
  • 9:00 AM - 9:30 AM: Registration, Meet & Greet.
  • 9:30 AM - 11:00 AM: Session 1: GxP/GMP and IT Systems (90 Mins)
    • GxP/GMP Requirements for IT systems in regulated industries
    • IT Systems Validation
  • 11:00 AM - 12:30 PM: Session 2: Change Control Procedure (90 Mins)
    • 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 (90 Mins)
    • IT Change Control Procedure Steps
  • 3:00 PM - 4:30 PM: Session 4: Document Management Systems (90 Mins)
    • SharePoint
    • Arena
    • TeamSite
    • OpenText
    • Oracle UCM
    • SDL Tridion
    • Open Source Systems
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Eleonora Babayants

Eleonora Babayants,
Founder and President, Galaxy Consulting

Eleonora Babayants - Founder and President Galaxy Consulting, 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, medical devices, food and beverages companies.

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