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Level: Advanced - Application
ISPE CEUs: 1.5
Type: Classroom Training Course
Includes Webinar

Description

This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer. 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.

Highlights of the course include:

• Overview of key themes and concepts in GAMP^® 5
• Understanding the business and manufacturing process and the overall GxP Risk
• Developing a strategy and writing a Computerized Systems Validation Plan
• Supplier assessment and leveraging supplier knowledge and documentation
• Choosing a suitable specification and verification approach
• GAMP 5 Quality Risk Management approach (based on ICH Q9)
• Specific risk assessment tools for computerized systems
• Selecting a suitable lifecycle and scaling the lifecycle based on risk, complexity, and novelty
• Dealing with end user applications, including spreadsheets
• Dealing with existing (Legacy) systems, by applying GAMP 5 principles
• Regulatory hot topics
• Question and answer session to address any outstanding issues

This course was developed by members of the ISPE GAMP^® Community of Practice. GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.

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

• Understand why the industry developed the GAMP^® guidance, the objectives of the Guidance, the history of the GAMP initiative and how it has evolved
• Review the structure and content of GAMP^® 5
• Define key GAMP^® 5 themes, concepts, and the GAMP system Life Cycle

Take Back to Your Job

• Build upon and expand understanding of the regulatory requirements and expectations for the compliance of computerized systems used in pharmaceutical manufacturing
• Apply this understanding to example systems and case studies
• Analyze case studies and apply the GAMP^® 5 process for achieving compliance and fitness for intended use
• Apply quality risk management and risk assessment concepts

Attendance Suggested For

• Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a practical understanding of computerized system compliance.
• Computer system vendors or consultants, engineering contractors, and validation service companies.
• Those who have previously attended a GAMP^® Basic Principles training course or those whose practical experience has provided the equivalent level of knowledge.

Community of Practice (COP)

This Training course is of particular interest to existing and future members of the ISPE GAMP^® Community of Practice (COP)

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Quality Systems: Systems Validation and Information Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

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.

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