Overview

Level: Fundamental 

Type: Certificate – Learning Pathway 


ISPE Continuing Education Units (CEUs): 6.7

Regulators recognize the importance of making sure computerized systems are fit for their intended use and that data integrity is assured throughout the pharmaceutical product lifecycle. This is especially vital for computerized systems directly impacting patient safety and data integrity during product development, manufacture, distribution, and supply of healthcare products, pharmaceuticals, biopharmaceuticals, vaccines, and medical devices. 

The GAMP^® Essentials certificate program, focused on good manufacturing practices (GMPs), provides helpful information for anyone in the industry involved in computerized systems compliance.  The program covers the principles and methods of a risk-based approach to the validation of computerized systems and practices. The program curriculum also provides insights on data integrity in alignment with ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). Particular reference is made to US and EU GxP regulatory requirements, including data integrity guidance and US CFR Part 11 requirements for electronic records and electronic signatures. 

This certificate program is recommended for organizations interested in defining and following a strategic approach to the adoption of computerized systems, including cloud-based solutions used within regulated environments. Strategic leads can demonstrate their core competence in computerized systems by completing this certificate program.

Key Learning Objectives

Upon successful completion of the certificate program, participants will be able to:

• Understand the importance and integration of quality systems and regulatory compliance.
• Know how to apply risk management methodologies throughout the product lifecycle.
• Author concise and complete deviations, perform true root cause analyses, effective CAPA, and plan for continuous improvement.
• Develop a tech transfer plan and execute a tech transfer.
• Utilize GAMP5 guidance to provide an effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
• Understand the elements of cleaning validation from start to finish.
• Apply the practical lifecycle approach to all stages of process validation.
• Perform GMP auditing for the pharmaceutical industry.

Course Curriculum

Course Modules

• GMP Fundamentals
• GAMP5 Overview
• Regulatory Guidance and Citations
• User Suppliers Activities
• Testing
• Quality Risk Management
• Data Integrity Overview
• Data Governance
• Annex 11/CFR Part 11 

Who Should Attend

• Computer system vendors or consultants, engineering contractors, and validation service companies
• Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, clinical support personnel, engineers, management information system (MIS) professionals, and all levels of management who need a fundamental understanding of computerized system compliance and regulations
• All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.

Community of Practice (COP)

This training course will be of particular interest to:

• GAMP
• GAMP Blockchain Special Interest Group
• GAMP Computer Software Assurance Special Interest Group
• GAMP Data Integrity Special Interest Group
• GAMP MES Special Interest Group

Pricing

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.

Register           Return to Certificate Page

For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses