Speakers

Yves Samson

Kereon

Dr Robert Stephenson

Rob Stephenson Consultancy

Stefan Münch

Körber Pharma Consulting

Objectives

Learn what activities and deliverables you should expect to see from your IS/IT supplier to demonstrate Supplier Good Practice
Learn how to verify your supplier’s capabilities so that there are “no surprises”.
Learn how to plan validation (verification) activities, leveraging the expertise of your supplier
Learn how to minimise duplication of effort between the supplier and your regulated company in order to achieve lean and effective processes throughout the system life cycle
Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship

Background

Recognising the potential savings and flexibility available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external suppliers to provide them with innovative and compliant products and services which fulfil their operational and business needs.

The EU-GMP Annex 11 on Computerised Systems states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’; ‘Leveraging Supplier Involvement’ is also one of the 5 key concepts of the GAMP®5 guidance ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.

This course aims to provide attendees with the knowledge, and opportunities to practice the skills required, to achieve successful partnerships with their IS/IT suppliers and to improve

Target Group

This ECA Training Course is directed at employees from Production, Quality Control/Quality Assurance, Engineering and IS/ IT, who have to assess, manage or work with computerised system or service providers.

The training course will also be of value to representatives from supplier organisations that are working or seeking to work with Regulated Companies in the Life Sciences Sector.

Programme

Computerised System Validation: Leveraging Suppliers

Seminar Programme as PDF

Introduction – What the Participants Expect

An open session capturing the expectations of the delegates.

Leveraging Suppliers Expertise: An Overview of Good Practice

What is current Good Practice?
Optimising Supplier involvement
Integrating the supplier’s expertise and deliverables into your validation process
How to do more with less

Performing a Supplier Assessment

Why Assess the Supplier?
The Overall Process
Assessment Topics
Types of Assessment
Corrective Actions & Follow Up Audits

Workshop: Selecting a Supplier

What factors to take into account?
How to focus the assessment?
How to engage with the supplier?
How to report and manage the findings?
Regulatory expectation

Supplier Audit – The Supplier’s View

Define the role of the supplier
What must the supplier do?
What must the regulated company do?

Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers

Quality Management System
Establishing Requirements
Producing Specifications
Testing and Release
Support and Maintenance

Workshop: Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers

Leveraging Supplier Testing

Test script development
Test script execution
Test script review and approval

Programme Computerised System Validation Master Class - 12-14 June 2024

Introduction – Gain Understanding of Delegate Experience and Background

Workshop 1: What the Delegates expect

Capturing delegates expectations
Sharing and reducing to key points in groups
Sharing with all delegates and tutors

Current Challenges and Evolution for CSV Activities

What does compliance really mean?
Data Integrity
Securing operation: cybersecurity
Project agility
Cost efficiency vs effective risk management
Applying critical thinking

Roles, Responsibilities and Governance

PQS – Pharmaceutical Quality System according to ICH Q10
Responsibilities
- Operational ownerships
- Supporting roles
QA oversight

Workshop 2: Governance Benchmark

Polling Exercise plus facilitated discussion
IT and System Governance
CSV Roles and Responsibilities
Role of Quality Unit

Practical Use of Scalability

What do we mean by Scalability?
How does it work in practice?
How can we combine documents successfully?
How much is enough?

Workshop 3: Scaleability of Validation Activities

LIMS – Laboratory Information Management System
Laboratory computerised equipment
Process control system: PLC – Programmable Logic Controller

Writing Requirements Documents

Requirements gathering
Writing good requirements
Use of templates / boilerplates
Requirement Quality

Ideal Content of a CSV SOP

Embedding the CSV SOP into the PQS
Topics to address

Data Integrity and Record Management: A Necessary Long-Term Approach

Regulatory context
Document life cycle
Retention requirements and constraints
Supporting processes
Areas of concern

System Classification – A Record-based Approach

Needs for record-based system classification
Classification criteria
Class A, B, C, D

Workshop 4: System Classification

Design Review – How to Apply Critical Thinking?

CSA – Computer Software Assurance
Scaleable Risk Management
Document Review

Workshop 5: Design Review Scaleability

Combining Risk Management & Design Review

Bringing Legacy Systems into Compliance

How to approach legacy system remediation
Examples
- Learning management system
- Laboratory Instruments

Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach against 12 good validation practices

Each good practice introduced
Delegates score themselves
Results consolidated and fed back
Allows delegates to compare their CSV system against best practice and other practitioners

Alternative & Agile Approaches

Alternative software development models
- Unified Process, Scrum
Agility objectives
- Need for flexible engineering methodologies
What Agile engineering is not
- What Agile engineering needs
Practical approaches and recommendation
- Conditions for success

Validating Spreadsheets

Why are spreadsheets high risks?
Design considerations
What is important (risk again)!
How to document spreadsheet validation

Code Review

Principles of code review
Regulatory expectations
Performing code reviews
How to document code reviews

Elaboration of a Data Integrity Programme

Data Integrity Programme: What to do?
- Topics to address
- Action planning
Embedding the Data Integrity Programme into the PQS
Progress Reporting

Case Studies: Complex Projects

Global projects
- Roles & Responsibilities
- Data-related requirements
Large systems
- Phase-based implementation and deployment
Interface projects
- Roles & Responsibilities
- Testing

Today / Future IT Compliance Challenges

Open Source Software validation
Challenge demands Infrastructure platforms for applications
Global systems validation vs local defence
Paperless recipes based production – ISA 95 / S 88
Cloud Computing – Data Integrity
Validating Artificial Intelligence (AI)
Challenges for data integrity on Lab-Systems

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more

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Further dates online

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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