GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - NA Guide Launch (E07)

9-10 June CEUs: 1.2

This is sponsored by the GAMP^® Community of Practice.

Business process, technical support, and quality are a partnership. This seminar is about cooperation and frustration-prevention requiring these three groups work together to achieve the best explanation of what is needed so that a technical support organization can support these goals most effectively. It is about effective communication among the parties:

Technical support can benefit by understanding expectations better, how to listen effectively to what is needed – the first time.
Business can benefit by understanding how to describe what they need, and what regulations they are trying to satisfy, so that technical support understands the outcome needs – the first time.
Quality can benefit by learning how to ensure that this process happens to the overall benefit of the company and thus Quality can better deliver compliance.

You can apply this to your particular organization structure, no matter the title of the responsible group. It would be ideal if companies could send teams representing each part of this process partnership.

In content terms, this seminar will address the longest phase of the System Life Cycle – the operation phase – which requires the implementation, management, and monitoring of a number of interrelated processes to demonstrate that computerized systems remain in a state of control and in compliance with company policies and regulatory requirements. We will take the “O” or Operations appendices from GAMP^® 5 and explain them in detail, indicating where they are scalable to the criticality of the system to which they are applied. Further, we will exemplify how text, RACI (responsibility, accountability, consulting, informed) tables, and flow charts all are tied together. The roles in RACI are tied to the roles in GAMP^® 5, and pivotally there are charts that indicate how one process can trigger others.

From handover at the end of the project phase, to system retirement / data migration at the end of a system’s useful life, these management processes and the evidential records they generate must be complete and subsequently used to indicate the level of care and identify any issues or trends in the performance of the systems. Depending upon the system’s criticality the processes can be scaled to an appropriate level – the risk-based approach – and a determination made of which processes are necessary for which systems.

Typically processes to be considered are: Handover, Support Services and SLAs, Performance Monitoring, Incident Management and CAPA, Change and Configuration Management (including Repair), Periodic Review, Business Continuity (including Disaster Recovery and Back Up & Restore), and Systems Administration.

This is a Good Practice Guide launch; registrants will receive a copy of this guide.

How You Will Benefit

At the conclusion of this session, participants will be able to:

Analyze their company’s processes and relationships to the benefit of effective and efficient technical support of business processes
Identify areas of their company’s processes that need improvement by benchmarking against others
Apply good practices as defined in the guidance -- within your own company’s culture

Who Should Attend

Engineers (OR Engineering Compliance Auditors), compliance auditors, automation and IT professionals who need to understand the philosophy behind the “Why do they care about this?” Quality, validation, and general compliance professionals. This is helpful to very large, as well as smaller companies, consultants, and third party support organizations.

(Stop driving your IT people crazy and understand why they are asking for what they ask for?)

Leaders

Winnie Cappucci, Bayer Healthcare, Retired, USA
Kathleen Samways, Consultant, KAS Associates, United Kingdom

Speakers

Arthur Perez, PhD, Dir. IT Risk Mgt & Compliance, Novartis Pharmaceuticals, USA
Christopher Reid, Director, Integrity Solutions, United Kingdom
Michael Rutherford, Consultant, Business Operations, Laboratory, and Quality Systems, Eli Lilly & Co, USA
Yves Samson, Sr Consultant/Director, Kereon AG, Switzerland
George Smith, Compliance Officer, FDA, USA
Robert Stephenson, IT Validation Consultant, Rob Stephenson Consultancy, United Kingdom
Charlie Wakeham, R&D Manager, Pall Life Sciences, United Kingdom
Sion Wyn, Director, Conformity Ltd., United Kingdom

Communities of Practice (COPs)

GAMP
Biotech
C&Q
Good Control Lab Pr
PAT

www.ISPE.org/COPs

Knowledge Elements

2 - Facilities and equipment
- C. Operation and maintenance
3 - Information systems
7 - Quality systems
- B. Systems validation (changed from Validated Controls)

Related Technical Docs and/or PE, JPI articles

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.