Data Integrity & Compliance for GxP Process Control Systems Training Course

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training 

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Integrating Data Integrity within a Risk-Based approach to Compliant GxP Process Control Systems (T21)

Overview

This highly interactive classroom course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, and GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP® 5 may be practically applied to process control systems. It looks at the data created by the process control system through the data lifecycle to understand how to protect against threats to data integrity. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.

This course shows how appropriate quality risk management, planning, specification, implementation, verification and reporting activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and the course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.

Practical “hands-on” workshop exercises using case study examples have been included to illustrate the approach covering a wide range of systems from basic equipment and instruments to large, complex, Distributed Control Systems.

The course concentrates on features of the system life cycle that are special, or particularly relevant, to process control systems including:

  • multiple components and multiple suppliers;
  • interfaces to a physical process being controlled in real time;
  • the degree of embedding of the computer system with the process equipment;
  • interfaces introduced by phasing of delivery.

These are analyzed in terms of both process functionality and data integrity

gamp_good_practice_guide_risk_based_approach_gxp_process.pngGAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records

Immediately apply the course objectives using the electronic download of the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition)  and GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records you'll receive by attending this course.

Course Modules

  • Key Concepts
    • Product and Process Understanding
    • Lifecycle Approaches and Categories
    • Scalable Activities
    • Risk Management
    • Leveraging Supplier Involvement
  • The Planning Stage
    • Risk Management
    • Approaches to Supplier Assessment
    • Validation Plan
    • Quality Plan
  • Specification Stage
    • Risk Management
    • Requirement Documentation and Traceability
  • Implementation Stage
    • Risk Management
    • Configuration Management
    • Coding and Code Reviews

 

  • Verification Stage
    • Test Principles
    • Writing a Test Script
    • Test Execution and Results
    • Recording
    • Test Incident Management
    • Test Review
    • Improving Efficiency
  • Reporting Stage
    • Risk Management
    • End User and Supplier Reports
  • Operation Phase
    • Repairs, Patches and Upgrades
  • Retirement
    • Data migration
  • ANSI/ISA-88
  • Process Analytical Technology

Take Back to Your Job

  • A comprehensive overview of current good practice for GxP regulated process control systems including data integrity
  • Harmonized approaches for all types of process control systems
  • Understanding of the process control system life cycle, and the data lifecycle
  • Discussion of the detailed engineering activities, covering:
    • Practical knowledge of applying the risk-based approach to system functionality and data integrity
    • Generation of accurate and complete user requirements with an early emphasis on product / process understanding and data flows
    • Effective collaboration between regulated companies and suppliers
    • Leveraging of supplier activities
    • Scalability of approach based on GxP risk, GAMP categorization, threats to data integrity and other factors

Who Should Attend?

  • Engineers who develop or maintain process control systems
  • System owners and data owners for process control systems
  • Quality assurance and quality control specialists,
  • Validation specialists,
  • Technical support personnel,
  • All levels of management who need a fundamental understanding of process control system compliance
  • Computer system vendors or consultants,
  • Engineering contractors,
  • Validation service companies

Community of Practice (COP)

This training course is of particular interest to existing and future members of the GAMP® Community of Practice (COP).

  • 4 June 2020 - 5 June 2020
    Boston, MA United States

    Daily Schedule

    Daily Schedule at a Glance
    07:00 – 08:30 Registration Open
    08:30 – 17:00 Training Course
    10:30 – 11:00 Refreshment Break
    12:00 – 13:00 Lunch
    15:00 – 15:30 Refreshment Break
    Instructors
    Former Director of CVS and CTO for ProPharma Group
    ProPharma Group
    EARLY

    BY 04 May

    Member US$
    1,985.00
    Non-member   US$
    2,350.00
    Government / Academia US$
    650.00
    Student Member US$
    90.00
    LATE

    AFTER 04 May

    Member US$
    2,085.00
    Non-member   US$
    2,450.00
    Government / Academia US$
    650.00
    Student Member US$
    98.00

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.

  • 15 June 2020 - 16 June 2020
    North Bethesda, MD United States

    Daily Schedule

    Daily Schedule at a Glance
    07:00 – 08:30 Registration Open
    08:30 – 17:00 Training Course
    10:30 – 11:00 Refreshment Break
    12:00 – 13:00 Lunch
    15:00 – 15:30 Refreshment Break
    Instructors
    Global Automation & IT Lead
    CAI
    EARLY

    BY 15 May

    Member US$
    1,985.00
    Non-member   US$
    2,380.00
    Government / Academia US$
    650.00
    Student Member US$
    90.00
    LATE

    AFTER 15 May

    Member US$
    2,085.00
    Non-member   US$
    2,480.00
    Government / Academia US$
    650.00
    Student Member US$
    98.00

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.

  • 18 November 2020 - 19 November 2020
    North Bethesda, MD United States

    Daily Schedule

    Daily Schedule at a Glance
    07:00 – 08:30 Registration Open
    08:30 – 17:00 Training Course
    10:30 – 11:00 Refreshment Break
    12:00 – 13:00 Lunch
    15:00 – 15:30 Refreshment Break
    Instructors
    Global Automation & IT Lead
    CAI
    EARLY

    BY 18 Oct

    Member US$
    1,985.00
    Non-member   US$
    2,380.00
    Government / Academia US$
    650.00
    Student Member US$
    90.00
    LATE

    AFTER 18 Oct

    Member US$
    2,085.00
    Non-member   US$
    2,480.00
    Government / Academia US$
    650.00
    Student Member US$
    98.00

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.