Data Integrity & Compliance for GxP Process Control Systems Online Live Training

ISPE Learning Solution - Online Live Training Online Live

Overview

This highly interactive virtual 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. This online 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.

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What You Will Learn

  • 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 an approach based on GxP risk, GAMP categorization, threats to data integrity and other factors

Resources and Activities

GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

Online Live Course Modules

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


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

Online Live Course Additional Details

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

Communities of Practice

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


Daily Schedule and Pricing

  • Online Live
    8 - 9 June

    Daily Schedule at a Glance

    Day 1
    0900 – 0915 Login and Registration
    0915 - 0930 Introductions
    0930 - 1045 Course Content & Exercise
    1045 - 1100 Break
    1100 - 1215 Course Content & Exercise
    1215 - 1245 Lunch
    1245 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Questions & Discussions
    All times for this training course date are displayed in CET.
    Day 2
    0900 Login
    0915 - 1030 Course Content and Exercise
    1030 - 1045 Break
    1045 - 1145 Course Content and Exercise
    1145 - 1200 Questions, Discussions, & Wrap-Up
    All times for this training course date are displayed in CET.

    Registration Fee

    EARLY

    On or Before 1 June

    Member US$1,695 
    Nonmember US$1,695   
    Government/Academia US$550
    Student US$90
    LATE

    On or After 2 June

    Member US$1,795    
    Nonmember   US$1,795   
    Government/Academia US$550
    Student US$98

    Mail or Fax Registration

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

    Now Your Whole Team Can Participate in an ISPE Online Live Learning Experience

    • 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.


    Instructor

    Michael Byrd

    Former Director of CVS and CTO for ProPharma Group
    ProPharma Group
  • Online Live
    27 - 28 July

    Daily Schedule at a Glance

    Day 1
    0900 – 0915 Login & Registration
    0915 - 0930 Introductions
    0930 - 1045 Course Content & Exercise
    1045 - 1100 Break
    1100 - 1215 Course Content & Exercise
    1215 - 1245 Lunch
    1245 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Questions & Discussions
    All times for this training course date are displayed in CET.
    Day 2
    0900 Login
    0915 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1145 Course Content & Exercise
    1145 - 1200 Questions, Discussions, & Wrap-Up
    All times for this training course date are displayed in CET.

    Registration Fee

    EARLY

    On or Before 20 July

    Member US$1,495 
    Nonmember US$1,695   
    Government/Academia US$550
    Student US$90
    LATE

    On or After 21 July

    Member US$1,595    
    Nonmember   US$1,795   
    Government/Academia US$550
    Student US$98

    Now Your Whole Team Can Participate in an ISPE Online Live Learning Experience

    • 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.


    Instructors

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