Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems Second Edition (T45)
Overview
This classroom or online course has been updated to include the new revised GAMP® Second Edition.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
What You Will Learn
- What are the international regulatory requirements for GxP computerized systems, including US 21 CFR Parts 211 and 11, and EU Annex 11?
- Overview of GAMP® 5 Second Edition Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- GAMP® 5 system lifecycle
- Scalable specification and verification based on risk
- Quality Risk Management for computerized systems
- Practical Risk Assessment methods
- Updated GAMP® Categories
- Role of users and suppliers - assessment and cooperation and leveraging supplier activities and documentation
- Testing in GAMP® - principles and practical approaches
- Pragmatic and efficient practices - cost effective compliance
- The role of IT Infrastructure in ensuring a compliant computing environment
- Effective and efficient approaches to end-user applications, including spreadsheets
This course is 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.
Resources and Activities
- Extensive Interactive Exercises
- GAMP® 5 Second Edition: A Risk-Based Approach to Compliant GxP Computerized Systems Guide
Course Modules
- Introduction
- Regulations and Regulators
- Data integrity requirements, including 21 CFR Part 11
- Overview of GAMP® 5 Second Edition
- GAMP® 5 Lifecycle in Detail
- Developing User Requirements
- Regulated Company and Supplier Activities
- Quality Risk Management
- Testing
- Operational Phases
- Effective and Efficient Compliance
- IT Infrastructure
- End-user applications, including spreadsheets
Who Should Attend
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations
- Computer system vendors or consultants, engineering contractors, and validation service companies
Additional Course Details
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering. It provides the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP® categories, supplier assessment, and the selection of appropriate specification and verification activities.
Learning Objectives
- Explain the regulatory requirements and expectations for computerized systems used in pharmaceutical manufacturing
- Apply GAMP® principles to specific systems and cases
- Describe the GAMP approach to computerized system compliance
- Apply these ideas to systems within your own organization
Communities of Practice
This training course is of particular interest to existing and future members of the GAMP® Community of Practice (COP).
Daily Schedule and Pricing
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Online Live11 - 13 Feb 2025Daily Schedule at a Glance
Training course times are listed in Eastern Standard Time (ET). Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
Now Your Whole Team Can Participate in an ISPE Learning Experience
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.
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Online Live7 - 9 Apr 2025
Daily Schedule at a Glance
Training course times are listed in Central European Time. Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
Now Your Whole Team Can Participate in an ISPE Learning Experience
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.
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In Person15 - 16 May 2025Daily Schedule at a Glance
Training course times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
Now Your Whole Team Can Participate in an ISPE Learning Experience
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.
Training Venue:
6110 Executive Blvd Suite #600
North Bethesda, MD 20852