Data Integrity & Computerised Systems (Team Package)
About this Course
Apply ALCOA+ in paper and electronic records and validate systems with a risk-based approach.
A team package: bought once by your company and used by every colleague who needs it, from 3 participants. Delivered as live virtual, case studies, with 4 modules and about 12 hours of training per participant.
See plans, the buying process and how to request a proposal on the Team Training Packages page.
What You Will Achieve
This package covers:
- ALCOA+ principles and data governance
- Audit trail review in practice
- EU GMP Annex 11, 21 CFR Part 11 and GAMP 5
- Computer software assurance and AI tools in GMP
Target Audience
QA, QC, IT, system owners.
Bookable for teams: Team plan (3–9 participants), Department (10–24), Enterprise (25+) or In-house at your site.
Program Outline
| Module | Topic | Duration |
|---|---|---|
| 1 | ALCOA+ principles and data governance | ~3 h |
| 2 | Audit trail review in practice | ~3 h |
| 3 | EU GMP Annex 11, 21 CFR Part 11 and GAMP 5 | ~3 h |
| 4 | Computer software assurance and AI tools in GMP | ~3 h |
30-Day Money-Back Guarantee
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Start Date Dates to be announced
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Location Team Package
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Language English
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Certificate Official Certificate of Completion