Speakers

Dr Rainer Gnibl

GMP Inspector

Yves Samson

Kereon

Dr Bernhard Appel

Roche

Please note: All times mentioned are CET.

Objectives

GMP-relevant computerised systems must be validated. The validation activities shall be sufficiently documented in order to allow inspectors as well as internal and external auditors to review and to understand the validation rigour and accuracy. The live online training will give an overview of the necessary qualification and validation documentation, including its structure and level of detail. The responsibilities of both suppliers as well as their regulated customers will be considered.

Background

“What is not documented has not been done!” The accurate documentation of all CSV activities is the prerequisite for successfully passing regulatory inspections as well as customer audits. On the other hand, creating the documents and maintaining their integrity is also time-consuming and costly. Here it is important to find a balance between “as few as possible but as much as necessary”.

Target GroupThis Live Online Training is directed at employees from the pharmaceutical industry and suppliers who have to prepare CSV documents and to document the validation activities of the computerised systems or who will have to carry this out in the future. Both beginners and employees with initial experience are addressed.

Technical Requirements

We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online- training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

Qualification Documentation Overview

Qualification / Validation Plan
System Description
Specifications
Requirements management / requirement traceability
Risk Management
Verification
- Design Review, IQ, OQ, PQ
- FAT, SAT
SOPs, agreements
Qualification / Validation Report
Qualification documentation scalability

Inspector’s Preconditions & Principles

Guidelines
Definitionen & Wording
Overall Responsibility
Essential PQS-Elements
Lifecycle Approach IT-System
Good Documentation Practice (incl. ALCOA)

Computerised System Validation: From Quality to CSV SOP and CS VMP

Regulator expectations to the PQS
PQS structure
Quality Manual
High level CSV SOP
IT- / CS-VMP

CS-VMP and Inventory Lists

CS VMP objective and purpose
- Planning / Reporting
CS VMP structure proposal
Management of the inventory lists
Proposal for system classification

Inspector’s View to Structure & Documents

Validation Structure
Documentation Structure
Essential Topics Project Phase (Validation)
Essential Topics Operational Phase (Routine)

Supporting SOPs within a CSV Scope

What SOPs?
SOP structure proposal
Recommendation

Data-/Documentation Management & Integrity

Lifecycle Approach Data/Documents
Identification of critical data/documents
Lifecycle & Integrity Risk
Data Governance Masterplan

Qualification / Validation Plan

Objectives
Responsibilities
Structure proposal for a Qualification / Validation Plan
Critical aspects
- Data flows
- Identification of the GxP relevant data
- Life cycle
- Risk management
- Overall acceptance criteria
- System release

Qualification / Validation Report - System Description

Objectives
Responsibilities
Structure proposal
Critical aspects
- Deviation from the planned procedure
- Failure and deviation handling
- Maintaining the qualified/validated state
System Description
- Objectives
- Responsibilities
- Structure proposal

URS – User Requirements Specification

URS objectives
URS structure proposal
- Functional vs non-functional requirements
Responsibilities
Recommendation

Design Review: Supplier Documentation / Solution Selection

Design review objectives
Leveraging supplier effort
- Review of services offered
- URS vs system functionalities
- URS vs system support, e.g.: SLA
- Quality and usability of the user manual
- Quality and usability of technical documentation
Design review report
Consolidation of the qualification/validation process

FS – Functional Specification

FS objectives
How much is enough?
- When is a FS required / needed?
- What content?
Responsibilities
FS structure proposal
Recommendation
- Process workflow and user roles
- Print-outs / reports
- Audit trail entries

CS – Configuration Specification

CS objectives
Responsibilities
Structure proposal
Content
Recommendation
- When is a CS required / needed?
- Configuration report vs Configuration Specification

Project Design Revie

Project consistency check
- Project approach
- Documentation
- Are the risk management outcomes properly taken into account?
- Are the audit report measures properly implemented
Traceability matrix
Design Review Report

Testing Documentation: IQ / OQ / PQ

Installation Qualification (IQ) & Configuration Specification (CS)
Operational Qualification (OQ) vs Functional Specification (FS)
Performance Qualification (PQ)
Scalability
Recommendation: How to leverage FAT & SAT results?

Q/V Project Close Down

Planning and supporting system handover
- Closing the Project
  - Which documents are needed?
  - Which documents need to be updated?
- Final system release
- Previous System Retirement

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

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

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To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

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Further dates on-site

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Further dates online

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Recording Available

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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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