Practical Application of Computerized Systems Compliance (Includes Webinar)
Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems

ISPE CEUs*: 1.5 (including Webinar)
Type: Classroom Training Course

Upcoming Dates and Locations

Date	Location	Country	Instructor(s)
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Description

In the realm of computer systems validation for pharmaceutical manufacturing, the real-life situations are as varied as the challenges they present – with complex factors such as risk, company policy, and regulatory requirements playing key roles. By offering a flexible framework for companies to apply validation principles to meet their unique requirements, GAMP 4, Good Automated Manufacturing Practice Guide for Validation of Automated Systems, has become a widely adopted industry resource.

This highly interactive workshop is equally flexible, giving participants hands-on experience in applying practical techniques and solutions to solve computer systems validation challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical systems, and have the opportunity to discuss their own real-life validation challenges with other participants and expert trainers. Participants should come prepared to work in groups to devise workable and creative solutions to realistic problems and case study scenarios, facilitated by the instructor.

The course outlines the importance of applying a documented and justified risk-based approach to computer systems validation.

Highlights of the course include:

• Overview of key themes and concepts in GAMP 4 
• Understanding the process and organization for validation 
• Computer systems master validation planning 
• Planning and performing a supplier audit 
• Developing and reviewing user requirement specifications 
• Performing and documenting risk assessments 
• Developing a validation strategy and writing a validation plan 
• Writing high-quality test scripts 
• Maintaining the validated state – change control and impact assessment 
• Regulatory hot topics

This course was developed by members of the GAMP Forum, a technical subcommittee of ISPE. The GAMP Forum was established by industry leaders to interpret and improve the understanding of regulations governing the use of automated systems in pharmaceutical manufacturing.

Participants will receive a complimentary copy of GAMP 4.

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ispe-pcc.org.

Webinar Learning Objectives

• Explain why the industry developed the GAMP guidance and the history of the GAMP initiative 
• Explain the objectives, structure, and contents of GAMP 4 
• Define key GAMP 4 themes, concepts, and the GAMP Validation Life Cycle 
• Describe validation strategy based on risk, supplier, and component assessment
  

Take Back to Your Job

• Build upon and expand understanding of the regulatory requirements and expectations for the validation of computer systems used in pharmaceutical manufacturing
• Apply this understanding to example systems and case studies
• Analyze case studies and apply the GAMP process for defining a validation strategy based on GAMP 4
• Apply risk assessment concepts

Attendance Suggested For

• Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, MIS professionals, and all levels of management who need a practical understanding of computer validation.
• Computer systems vendors and validation service companies.
• Those who have previously attended the Basic Principles of Computer Systems Validation Using GAMP 4 training course or those whose practical experience has provided the equivalent level of knowledge.
• This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).

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 mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

About On-line Essentials

This course includes On-line Essentials, a pre-recorded, Web-based session that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the On-line Essential two weeks prior to the start of the training event.