Microlearning: GAMP® Basic Principles – Validation and Data Integrity for Spreadsheets and End User Applications
Overview
The "Data Integrity and 21 CFR Part 11" section of the GAMP® Basic Principles (T45) training course provides a comprehensive overview of regulatory expectations for data integrity, electronic records, and electronic signatures in GxP environments. Drawing from FDA guidance, MHRA definitions, and the ISPE GAMP® Records and Data Integrity Guide, the module emphasizes the importance of complete, consistent, and accurate data throughout its lifecycle. Participants explore the scope and application of Part 11, and topics including predicate rules, audit trails, access controls, authority checks, and signature manifestations. The course highlights common inspection findings, risk-based compliance strategies, and the role of organizational culture and leadership in fostering data integrity. Learners gain the knowledge to assess systems for Part 11 applicability, define audit trail requirements, and implement compliant electronic signature controls.
Earn 0.13 CEUs
This course is self-paced. (Courses usually take 15 to 90 minutes to complete.)
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
ISPE Membership Benefits
Become a member today
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
Member-only discounts on Guidance Documents, Conferences, and Training
Pharmaceutical Engineering® magazine
Communities of Practice access to pharma professionals in specific topics from around the world
ISPE training is priced using Global Access Pricing, a four-tier model designed to reflect what a course actually costs in your country, not just what the US price converts to.
Because course fees vary, tiered rates are applied as a percentage of the standard US price. Your rate is calculated automatically at registration based on your country, and applies to both member and non-member pricing.
Tier
Member
Non-member
Tier 1
Standard pricing
Standard pricing
Tier 2
US$ 620
US$ 805
Tier 3
US$ 454
US$ 575
Tier 4
US$ 300
US$ 345
Example: Rates shown are based on a course listed at US$ 2,000 for members and US$ 2,300 for non-members. Actual amounts vary by course.
