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Seminar Price Details

19
Days Left To REGISTER
Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Overview

The current GXP regulations focus more and more on the topic of risk management in CSV. This seminar will provide you with guidance in carrying out risk assessments when validating computerized systems. The basis of the seminar will be the current requirements for the validation of computerized systems, such as GAMP®5, and their GxP-oriented application in practice. 

Why you should attend

Computerized systems are a central factor in achieving GXP compliance in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention, but this means that all computerized systems which can influence the quality of pharmaceutical products must be fully validated. 

Areas Covered in the Session

  • GAMP®5 - A Risk-Based Approach to Compliant GXP Computerized Systems
  • ICH Q9 - Quality Risk Management
  • 21 CFR Part 11
  • Eudralex Annex 11
  • FDA, MHRA & WHO guidances on data governance & data integrity

Learning Objectives

  • Gain understanding of the principles and methods of the validation of computerized systems (according to GAMP®)
  • Understand the latest FDA, MHRA and WHO guidances for data integrity
  • Learn to plan, implement and document effectively validation activities for computerized systems and to assess them with respect to their GxP compliance
  • Know the current risk management approaches of ICH Q9 and the GAMP®5
  • Become familiar with the latest methods and tools for risk analysis and assess their relevance for validation of computerized systems
  • Learn how the activities involved in the validation of computerized systems can be controlled efficiently by means of risk management

Who Will Benefit

  • Staff from Production 
  • Quality Control / Quality Assurance
  • Engineering 
  • IT validation involved with the planning
  • Implementation and evaluation of the of computerized system validation (CSV)

Agenda

Day 1 Schedule

Lecture 1: Laws, Regulations and Guidelines for Computer Systems Validation & e-records

  • 21 CFR Part 11
  • EU Good Manufacturing Practice Annex 11
  • MHRA 'GXP' Data Integrity Guidance
  • WHO Annex 5 guidance on good data and record management practices 
  • GAMP®5

Lecture 2: Risk Management in Computer Systems Validation

  • Benefits of Risk Management
  • Risk Assessment
  • Risk Control
  • Risk Ranking

Lecture 3: The GAMP®5 Approach to Computer Systems Validation

  • What is a computerised system?
  • GAMP®5 Structure
  • Key Concepts
  • Specification & verification approach

Lecture 4: The Computer Systems Validation Process

  • User Requirement Specification
  • Supplier Assessment
  • Functional Specification
  • Design Specification
  • Acceptance Testing

Day 2 Schedule

Lecture 5: Planning a Computer Systems Validation Programme

  • Validation Plan
  • Roles & Responsibilities
  • Project Management & Validation
  • Validation Planning & Strategy
  • Documentation

Lecture 6: User Requirement Specification (URS)

  • Scope of a URS
  • URS Contents
  • Operational Requirements
  • Life cycle Requirements

Lecture 7: Assessing & Selecting Suppliers

  • Why assess the Supplier?
  • Types of Supplier assessment
  • Risk-based approach to Supplier assessment
  • Periodic Re-evaluation of Suppliers

Lecture 8: Change Management

  • Hardware
  • Software
  • Master Data
  • Configuration Management
  • Planned or Unplanned?
  • Service Packs
  • Third Party Upgrades

Lecture 9: Validation Reporting

  • Different kinds of validation report
  • What should the report include?
Presentations will be supported by group exercises enabling participants to practice skills.
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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Robert Haslam 

Managing Director,
Somerset House Consultants


Robert Haslam is a pharmaceutical industry VP with over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice.

He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.

Venue

Location: London, UK
Hotel: London Hilton on Park Lane