GAMP®: Guided Tour of the World of Good Practice Guides

Monday 20 September - Tuesday 21 September

Seminar Content Level: Intermediate - Advanced

Seminar leaders: Jens Seest, Leo Pharma (Denmark); Tim Goossens, MSD (Belgium)

The seminar will focus on GAMP Good Practice. It will provide the delegates with an overview of the guides, together with case studies and workshops. The objective is to help the delegates to identify which particular good practice guide is relevant for their job. The presentations will not be indepth technical by nature, but more from an application perspective.

Take Back to Your Job:

• Identify which GPGs are relevavnt for your job
• Understand how each GPG provides benefit in your job
• Be aware of applications of best practice via case studies
• Understand the regulatory viewpoint on the GPGs

Who Should Attend:

• Practitioners operating computerised systems e.g. automated systems, laboratory computerised systems, information systems and IT infrastructure
• Site engineers, system supporters, IT department

Related Technical Documents:

GAMP^® Good Practice Guides:

• Manufacturing Execution Systems – A Strategic and Program Management Approach
• Electronic Data Archiving
• IT Infrastructure Control and Compliance
• Global Information Systems Control and Compliance

Community of Practice (COP):

GAMP

 

Programme

Day 1, Monday 20 September

10.00 – 10.15 Welcome and Introduction
Jens Seest, Leo Pharma (Denmark); Tim Goossens, MSD (Belgium)

10.15 – 11.30 Introduction to and Overview of the Good Practice Guides
Chris Reid, Integrity Solutions (UK)

• Introduction to main documents referenced in this seminar: MES; Data Archiving; Infrastructure; Global Information Systems
• Overview of other available guidance documents

11.30 – 12.15 Regulatory Overview
Speaker to be confirmed
Stay tuned for updated session information.

12.15 – 13.45 Lunch and Networking Break

13.45 – 15.15 Infrastructure Compliance Lifecycle Presentation and Workshop
Kofi Frimpong, Merial (USA); Tom Meulders, Dataflow Consultancy (Belgium)
The consequences of IT Infrastructure being of effective compliance can be significant since it has a direct impact on the validation status of the GxP applications hosted on them. This session discusses a scalable, cost-effective IT infrastructure compliance and control process which focuses on:

• The paradigm shift from manual infrastructure qualification to using scalable prequalified infrastructure components (building blocks
• Using scripted verification reports to provide verifiable assurance of compliance with predefined standards
• Ongoing maintenance of the qualified state, including incident, change and configuration management
• Piloting a new IT infrastructure qualification methodology in an international organisation, project challenges and lessons learned
• Scalable prequalified infrastructure components (building blocks)
• Using scripted verification reports to provide verifiable assurance of compliance with predefined standards
• Ongoing maintenance of the qualified state, including incident, change and configuration management
• Piloting a new IT infrastructure qualification methodology in an international organisation, project challenges and lessons learned

15.15 – 15.45 Break

15.45 – 17.30 Infrastructure Compliance Lifecycle Case Study and Workshop (continued)
Kofi Frimpong, Merial (USA); Jo De Troy, Johnson & Johnson (Belgium); Tom Meulders, Dataflow Consultancy (Belgium)

• Differences between manual infrastructure qualification and scripted infrastructure qualification
• Advantages and disadvantages of the new process
• Future deployment strategies
• Workshop – hands-on exercise

17.30 – 17.45 Questions and Answers, Close of Day 1
Jens Seest, Leo Pharma (Denmark); Tim Goossens, MSD (Belgium)

17.45 – 18.45 Exhibition Networking Reception

18.45 – 20.30 Infrastructure: Round Table in Cooperation with GAMP Benelux
Tim Goossens, MSD (Belgium)

 

Day 2, Tuesday 21 September

09.00 – 09.15 Review of Day 1, Introduction to Day 2
Jens Seest, Leo Pharma (Denmark); Tim Goossens, MSD (Belgium)

09.15 – 10.15 MES - Case Study
Paul Irving, Aptitude (UK); Anders Brummerstedt, NNE Pharmaplan (Denmark)

• Overview of the MES Guidance: strategic planning, a domain of functionality, describe electronic production records, review by exception
• MES implementation: complexity and organisation, business process analysis, master data, systems interfaces, key people and key knowledge, governance issues

10.15 – 10.45 Break

10.45 – 12.30 Data Archiving - Case Study and Workshop
Peter Werner Christensen and Niels Andersen, NNE Pharmaplan (Denmark)
Issues around the long term preservation of electronic data.

• Regulatory view on electronic records
• Archiving concepts - electronic versus paper archiving
• Considerations when archiving electronically
• Developing an archiving strategy

12.30 – 13.30 Lunch and Networking Break

13.30 – 16.00 Global Information Systems – Case Study and Workshop
Winnie Cappucci, Bayer (USA); Randy Perez, Novartis (USA)
Validation and compliance can be tricky issues to manage for computer systems that are deployed at multiple sites, whether internationally or intranationally. This session addresses a variety of issues unique to managing the development and support of validated global computer systems such as:

• The affect of system architecture on validation strategy
• Minimising duplicated effort: leveraging centralised testing
• Data management for global systems
• Global system management, including managing change, configuration, and security

16.00 – 16.15 Questions and Answers, Close of Seminar
Jens Seest, Leo Pharma (Denmark); Tim Goossens, MSD (Belgium)