Electronic GMP Systems Specification - Implementation - Validation

Electronic GMP Systems Specification - Implementation - Validation

Prague, Czech Republic

Course No 9181


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Kai Kiefer, fme AG, Germany
Dr Bob McDowall, McDowall Consulting, UK


During this Master Class you will get to know benefits and risks using electronic solutions for GMP and Quality Assurance systems. You will learn how they work and interact, and what needs to be considered when specifying, implementing and validating them.

Experts will show you possibilities to improve your systems and how to use them efficiently and in compliance with the (c)GMP regulations.


Computerised systems have been used for many years in pharmaceutical industry. Their use increases product safety, improves speed of processes, ensures data integrity and saves time and costs in manufacturing. However, these benefits only come if the system has been implemented and validated correctly. Over the last years, electronic solutions for GMP- and QA-Systems have been getting more and more sophisticated and popular for the same reasons. They are able to remove much of the paper work that is still used in quality assurance, manufacturing and quality control.

But while implementing those systems, a lot of factors have to be considered and questions to be answered both from a technical and compliance point of view:
Ensuring your system is correctly specified
How to identify the best system for your needs
Strategic design of electronic solutions
How to manage the project
Management of costs and risks
Effective and efficient computer validation
Efficient and compliant implementation

Increasing cost pressures on pharmaceutical companies mean that internal efficiencies are essential to ensure profitability from manufacturing operations but also in R&D. And implementing electronic systems first of all needs a lot of resources: people, money, time. Therefore it is of utmost importance to do the right things: choose the right systems, implement them quickly and efficiently and get the most out of them.

In June 2011, the new versions of EU GMP Annex 11 and Chapter 4 became effective. The course will look at how these requirements have impacted the validation and
operation of electronic solutions.

Target Group

This Education Course is designed for all persons in pharmaceutical, biopharmaceutical and API industry who are involved in projects establishing, implementing and improving electronic solutions for GMP Systems:
Quality Assurance
Project Management
Business Development
Quality Control


Why Use Electronic Systems Not Paper?
Business and regulatory drivers for working
Benefits of electronic working locally and globally
Ensuring product quality and supply chain integrity through end-to-end traceability
The human element of electronic systems
Agility in responding to changed product and
production requirements
Ensuring product quality through end-to-end
Effort required to maintain state-of-the-art electronic process support

User involvement in Electronic Systems Projects
Understand impact of IT systems on organizations
Strategies to identify and ensure evolvement of stakeholders & users
Techniques to develop common project vision
Techniques to motivate and manage user involvement in all project phases

Role of Specification Documents in the selection and implementation of new Electronic Systems
User requirements specifications – essential for system selection and defining what to validate
Configuration specifications – how is an application changed to match your requirements?
Functional specification – is one essential
Essentials of traceability in the life cycle
Design specification – when custom additions are required

Effective and Efficient Implementation and Use of
Electronic GMP Systems
Process mapping and redesign as an essential part of understanding the business process and an essential pre-requisite for implementation of an electronic solution
Techniques for process analysis and design
Applying Total Quality Management principles for process design

Impact of the new GMP Regulations including Annex 11 on Electronic Systems Design and Validation
EU GMP Annex 11 and Chapter 4 requirements
Impact of the new clause of US GMP: 21 CFR 211.68(c)
Impact of Compliance Programme Guide 7346.832 on Pre-Approval Inspections on Computerised Systems
Impeding an FDA inspection?
Impact of the FDA’s new Post Inspection Response programme – are you inspection ready?
GAMP®5: flexibility not constraint?

Principles of Project Management
Fundamentals of Project Management
Overview of current Project Management Practices
Typical breakdown of a classical Project
Key roles in a project: project manager and project sponsor
Project team members – where do they come from and what do they do
Interactions of line management (organisation)
versus the project team (matrix management)

Specification of User Requirements
Why are user requirements essential: business and regulatory reasons
Who is involved writing requirements?
Why traceability of requirements is critical for both regulatory and business reasons
Methodology for writing requirements
The Homer Simpson requirements analysis tool

How to Decide on a Solution
Understand the process of evaluating solutions
Case Studies: Effectively evaluate a solution and a solution provider by example
How to audit suppliers quality of IT suppliers efficiently

Implementing and Rolling out a System
Typical breakdown of a classical Project
Compare Roll-out Approaches on Case Studies: Document management vs. Complaint management Roll-outs
Managing Validation, Change & Training on site level
How to deal with global implementation teams

Going to the Cloud with a GMP System?
What is the Cloud?
Types of cloud offering: IaaS, PaaS or SaaS
Criteria for selecting a hosting company
Is the IT infrastructure qualified?
Annex 11 requirements for service providers: agreements and assessments

Ways to Ensure Data Integrity in Electronic Systems
Ten commandments for data integrity and regulatory compliance when using electronic systems e.g. ensure that you have enough user licenses to uniquely identify users

Efficient and effective validation of Electronic Systems
How effectively manage the key elements of GAMP
Understand importance of applying good Application Management Practises for validation
How deal with challenges in managing agile projects
How to validate Interfaces, Data Migrations & Reports

Electronic Systems:
Conducting Audits and Periodic Reviews
The impact of working electronically will change the way that we audit and review manufacturing facilities, laboratories and computerised systems
Periodic reviews versus audits – are they the same?
What do we need from the systems?
What do we need from the auditors / inspectors?
The future of audits and inspections? Remote access and video conference discussion?

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