Computer Systems Validation Master Class & Leveraging Suppliers - Save up to EUR 490 by booking both courses - Im Auftrag der ECA Academy

Computer Systems Validation Master Class & Leveraging Suppliers  -  Save up to EUR 490 by booking both courses  -  Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 16069


Kosten

Non-ECA Members: EUR 2390,--
ECA Members: EUR 2190,--
EU GMP Inspectorates: EUR 1440,--
APIC Members (does not include ECA membership): EUR 2290,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Frank Behnisch, CSL Behring, Germany

Maik Guttzeit, GEA Lyophil, Germany

Yves Samson, Kereon AG, Basel, Switzerland

Dr Rob Stephenson, Rob Stephenson Consultancy, UK

Programm

Computer Validation: Leveraging Suppliers

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

Identifying Leveraging Opportunities 1: Quality Planning
Quality Planning
Assuring Quality
Quality Controls

Identifying Leveraging Opportunities 2: Leveraging Testing Activities
What must the supplier do
What must the regulated company do
Which supplier tests can be accepted

Managing Quality within an Outsourced IS/IT Environment
Making a Business Case
Outsourced Supplier Specification and Selection
Implementation
Monitoring
Contract Change and Exit

Computer Systems Validation Master Class

Introduction – Gain Understanding of Delegate
Experience and Background

Roles, Responsibilities and Governance
Activities for Effective Governance
Process and System Ownership
The role of Subject Matter Experts
The role of QA

Writing Requirements Documents
What goes into a requirements document?
What are the considerations for systems?
Characteristics of good and bad requirements documents
Sources of requirements information

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?

Making Use of Risk Information
Generation a process risk register
Using the risk register to:
Identify the range of risk-based controls necessary for the effective management of the process
Identify critical tests for qualification or verification
Help manage change, incidents, the focus for audits etc.
Identify the residual risks to be managed
Show embedding of risk management within the
Quality Management System

Design Review – A Critical Process
When to perform a Design Review?
Who should participate?
How to document the Review
How to manage the findings

Upcoming Challenges in IT
Open source software
Global systems
Paperless Production: EBR with Vertical Integration
Cloud Computing / Virtualisation
Infrastructure Qualification / ITIL
Outsourcing

Interactive Session: Good Validation Practices
Open session in which delegates score their CSV system themselves 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

Change Control and Configuration Management
Responsibilities
Planned/unplanned changes
Classification

Interactive Session: Change Control Examples
Delegates will work on a variety of change management scenarios
Evaluating the magnitude and impact of the change
Application of the principles of risk management
Leveraging supplier and SME (Subject Matter Expert) expertise
Minimising the workload whilst maintaining compliance

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

Risk Management and Electronic Records
A clear definition of electronic records with examples
An overview of the principles of risk management applied to the classification of electronic records
When is an audit trail needed
Do we need to keep chromatographic (and other) raw data?
Examples of the application of controls
Impact of the approach on validation of e-record systems

Code Review
Principles of code review
Regulatory expectations of code review
Carrying out code reviews
Recording and documenting code reviews

Data Integrity – Formulating a Company Strategy
Management accountability
Incorporation of data governance in the Quality
Management System
Defining appropriate metrics
Auditing the data integrity processes
Reviewing progress

Handover – the Process and Package
What is the handover process?
Who is the system owner?
What does the system owner have responsibility for?
How can we persuade the system owners to accept responsibility?

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