Validation of Computerised Systems

Course Dates: 12 & 13 May 2009 to be re-scheduled   Venue:

Cost: £1160.00  + VAT

Course details

This Two-day course on validation and GxP compliance of computerised systems in the pharmaceutical industry is based on GAMP 5.0 and the latest regulatory and industry developments. GAMP guidance provides an effective framework for achieving computerized systems that are “fit for intended use” and meet current regulatory requirements.

The course will have a highly practical approach and will include a mix of theoretical introductions and workshops covering the main activities to be executed during the life cycle of a system. from which participants will expect to gain answers to problems in their own work environment. The workshops will cover topics such as "what a good User Requirements Specification should look like" and "when 21 CFR part 11 will be triggered or not".

Upon completion of the course participants will have a complete understanding of the terminology used and the validation activities that need to be performed throughout the life cycle of a Configurable Off the Shelf System (COTS) and

       Understand the GAMP 5 principles

• Oversee all required validation activities (SLC)
• To appoint the relevant Standard Operating Procedures (SOPs)
• Able to execute the validation of a “simple” system
• To participate when validating “complex” system
• Discuss validation issues with validation and Quality experts
   

Speaker

Piet Vervoort RE CISA, is the founder and managing director of Rescop BV (www.rescop.com).  Piet worked for several years as Corporate Senior IT-Compliance officer for an international pharmaceutical Company.

Having more the 10 years experience with validation of computerized systems. Piet has an international certification as Certified Information System Auditor (CISA), he also performs many supplier audits at ERP, LIMS, MES and other software suppliers. Piet is very experienced in how to implement regulatory requirements and how to put the guidelines (GAMP) into practice. Rescop has developed an enterprise compliance management system (RC-ECMS) which defines and supports the total life cycle activities of every given system according the GAMP-5 standards.

PROGRAMME

DAY 1 GAMP 5 course

Introduction

9.00                 Introduction and Welcome

                       Terms and Definitions

                       EU and EU Regulation and guidelines

                       GxP/Part 11 Impact Assessment

                       Workshop: Impact Assessment

 Planning phase

                       Introduction of the GAMP V-Model

                       Planning phase, VMP and VP

                       Supplier Assessment

                       Defining Roles and Responsibilities

                       Workshop: Roles and Responsibilities

 Specifications phase

                       Analysing business process

                       Business Process Risk Analysis (HACCP)

                       Requirements Specifications (URS)

                       Workshop: Writing Specifications

 DAY 2 GAMP 5 course

Risk Management

                       Risk management (ICHQ9)

                       Risk Analysis (FMEA)

                       Workshop: Perform Risk Analysis

Verification phase

                       Introduction to Verification

                       How to involve FAT/SAT testing

                             Workshop: Making a verification protocol Validation Report

 Operational phase

                       Overview of operational processes

                       CAPA, SLA, CC, CM, security, etc.

                       Workshop: Change Control procedure

 Evaluation of Course

                       Feedback

                       Complete  evaluation form

                       Close

 After course event (optional)

                       Presentation of the RC-ECMS system