Good Laboratory Practice (GLP) and Data Integrity (ALCOA+) Corporate Training
Learn GLP essentials and data integrity practice with ALCOA+ controls, audit trails, and inspection readiness in guided labs.
Edstellar, a corporate training company, delivers corporate training that helps your team learn Good Laboratory Practice and data integrity from first principles to inspection readiness. Employees develop the habits behind attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available records, then build the documentation discipline that stands up to regulatory scrutiny in guided labs led by practitioners. Each session is tuned to your study types, systems, and workflows.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a GLP-ready laboratory team
The Edstellar GOOD LABORATORY PRACTICE CAPABILITY MODEL
Assess data integrity maturity
Skill checks map your team's GLP awareness, ALCOA+ habits, and records control baseline.
Set shared documentation standards
One shared playbook for attributable records, controlled entries, and review checkpoints.
Practice in guided labs
Labs cover ALCOA+ classification, audit trails, computerized systems, and deviation triage.
Measure the lift
Lab reviews and the capstone assessment benchmark each employee's GLP capability.
Scale across studies
One standard rolls out across studies, sites, and lab functions.
Need more than one program?Get a group quote
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Program Overview: What is Good Laboratory Practice (GLP) and Data Integrity (ALCOA+)?
Good Laboratory Practice (GLP) & Data Integrity (ALCOA+) is a 24-hour program for lab managers, analysts, and quality professionals whose data must survive regulatory scrutiny. It covers GLP foundations and the regulatory landscape, ALCOA+ principles in daily practice, data lifecycle with records and audit trails, computerized systems with Part 11 and validation, and audit readiness with deviations and CAPA. Participants learn to generate data regulators trust.
The program mixes regulatory instruction with lab-focused exercises: participants apply ALCOA+ principles to real records, trace data lifecycles and audit trails, and work through computerized system validation scenarios. Deviation and CAPA exercises rehearse the responses inspectors expect. Instructors with lab quality experience review every exercise, correcting the record-keeping habits that draw the most common findings. It closes with a capstone delivering an end-to-end data integrity assessment.
Data integrity failures destroy more than studies: backdated records, missing audit trails, and uncontrolled spreadsheets have triggered warning letters, product holds, and criminal referrals. Regulators now assume data is guilty until proven ALCOA+. This program builds the daily habits and system controls that make every record defensible.
The capstone is an end-to-end data integrity assessment of a realistic laboratory: teams evaluate records against every ALCOA+ principle, trace audit trails through the data lifecycle, assess computerized systems for Part 11 compliance, and review deviation and CAPA handling. Each team presents findings and a remediation plan to instructors acting as inspectors, defending every call under pressure. Participants return with an assessment method they can deploy in their own labs and the practiced judgment to catch integrity risks early.
Good Laboratory Practice sets the rules for planning, performing, monitoring, recording, archiving, and reporting nonclinical studies, and data integrity is how those rules survive contact with real laboratory work. This program teaches both together: the regulatory expectations from OECD and FDA sources, and the practical controls that keep study data trustworthy.
What's Included in this Workshop for Your Enterprise Teams
- 1
GLP regulation walkthrough
Map OECD principles and 21 CFR Part 58 to your studies.
- 2
ALCOA+ classification labs
Grade sample records against every ALCOA+ attribute.
- 3
Records lifecycle labs
Run study data from generation to archiving under control.
- 4
Computerized systems practice
Configure access, audit trails, and e-signatures in a demo system.
- 5
Capstone assessment
Assess a full study data package and present findings.
- Instructor-led delivery across virtual, onsite, and hybrid
- Guided labs in every module with instructor coaching
- Capstone integrity assessment, reviewed with your team
- Flexible scheduling around your calendar
- Lab guides, record templates, and SOP checklists included
- Group size and batches set along with you
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
- Plan from 2000+ Industry-ready Training Programs
- Hands-On Labs on Live Infrastructure, Led by Industry Experts
Good Laboratory Practice (GLP) and Data Integrity (ALCOA+) Course Topics and Program Outline
A tailored 24-hour, six-module workshop: one learning journey from GLP foundations and ALCOA+ principles to a capstone integrity assessment of a live study package. Sessions pair concepts with labs on real-world use cases. Materials include lab guides, record templates, SOP checklists, and a capstone assessment.
Built by Edstellar with GLP and QA practitioners
Built by practitioners who run GLP studies and quality systems in production, shaped around your stack and use cases.
Skill checks baseline your team's GLP awareness, ALCOA+ habits, and records control maturity before training starts.
Live instruction covers GLP regulation and ALCOA+ principles across 6.5 focused hours of foundations.
Guided labs build records control, systems, and review skill across 8.5 hours of supervised practice.
Your team applies the full integrity toolkit in 9 hours, finishing with a capstone study package assessment.
From GLP foundations to a capstone integrity assessment, every technique is practiced in guided labs.
Delivered as
Delivered as a hybrid program of live instruction and guided labs, scheduled around your team's calendar in flexible batches.
Map GLP regulation sources to a sample study outline in a guided walkthrough, flagging every requirement by clause.
learna)OECD GLP principles and FDA 21 CFR Part 58 structure
b)Roles: study director, QA, archivist, and study personnel
c)Study types in scope and what sits outside GLP
d)Mapping your organization's SOPs to GLP expectations
Classify sample lab records against each ALCOA+ attribute in guided exercises, justifying every grade.
learna)Attributable, legible, contemporaneous, original, accurate
b)Complete, consistent, enduring, and available
c)Common ALCOA+ failure patterns in lab records
d)Corrections done right: single-line, signed, dated, explained
e)Raw data, second persons, and contemporaneous recording habits
Run a study data lifecycle end to end in a demo setup: generate records, review audit trails, and archive with retrieval controls.
practicea)Study data lifecycle: generation, review, reporting, archiving
b)Paper, hybrid, and electronic record models
c)Audit trails: what to capture and what to review
d)Review by exception and second-person checks
e)Archiving, retrieval, and retention periods
Configure user access, e-signature workflows, and validation checks on a mock lab system with instructor coaching.
practicea)21 CFR Part 11 controls: access, e-signatures, audit trails
b)Computer system validation: IQ, OQ, PQ in the lab context
c)User account management and privilege reviews
d)Change control and system retirement
e)Spreadsheet and instrument data: common risk points
Run a mock inspection on sample study documentation, triage integrity deviations, and draft a CAPA plan for review.
applya)Inspection anatomy: what inspectors ask and where records fail
b)QA audit vs regulatory inspection: roles and conduct
c)Data integrity deviation triage and impact assessment
d)Writing CAPA plans that address root causes
Assess a full study data package against GLP and ALCOA+ and present your findings report for instructor review.
applya)Capstone brief: the study package under review
b)Full ALCOA+ assessment of records and audit trails
c)Findings report with deviation and CAPA drafts
d)Presentation and instructor review of your assessment
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Seven job-ready outcomes your team will demonstrate by the end of the program. Each competency is practiced in guided labs and reviewed in the capstone assessment.
Interpret GLP regulatory requirements
Translate OECD principles and 21 CFR Part 58 expectations into concrete study and documentation obligations.
Apply ALCOA+ to every record
Grade laboratory records against all nine ALCOA+ attributes and correct gaps before review.
Execute controlled corrections
Make single-line, signed, dated, and explained corrections that preserve original data.
Manage the study data lifecycle
Carry records from generation through review, reporting, and archiving with complete audit trails.
Operate compliant computerized systems
Configure access controls, e-signatures, and validation checks on lab systems.
Triage data integrity deviations
Assess deviation impact, contain risk, and route findings through QA processes.
Build inspection-ready documentation
Assemble study packages and CAPA plans that stand up to regulatory inspection.
Teams that Benefit from this Good Laboratory Practice (GLP) and Data Integrity (ALCOA+) Group Training
This group training is built for lab, quality, and study groups that must run nonclinical work under GLP. Content adapts to each cohort's roles, systems, and experience, so every batch practices the documentation workflows it owns, from raw data capture to inspection defense.
Own GLP compliance with confident audit trails.
QA professionals learn to audit study records against ALCOA+, run readiness reviews, and verify CAPA effectiveness across studies.
Workflow friction
- Inconsistent record review criteria
- Deviation backlogs with unclear impact
- Inspection findings that repeat year to year
How the program helps
- ALCOA+ audit checklists tuned to your SOPs
- Deviation triage criteria reviewers trust
- CAPA review loops that close findings faster
Practice use cases
- QA audits
- Readiness reviews
- CAPA verification
Run daily lab work the inspection-ready way.
Study personnel and lab teams practice contemporaneous recording, controlled corrections, and system use that keeps raw data defensible.
Workflow friction
- Back-dated or reconstructed records
- Corrections without documented reasons
- Paper and electronic records drifting apart
How the program helps
- Contemporaneous recording habits that stick
- Correction routines auditors accept first time
- System workflows mapped to lab routines
Practice use cases
- Raw data capture
- Controlled corrections
- Instrument records
Deliver studies with clean, traceable data.
Study directors and coordinators learn to plan data flow, assign documentation responsibility, and keep study files audit-ready from day one.
Workflow friction
- Unclear documentation ownership
- Study files assembled under pressure
- Protocol vs record mismatches
How the program helps
- Study data plans reviewers can follow
- Clear ownership of every record type
- Faster closeout with complete files
Practice use cases
- Study planning
- File management
- Study closeout
Keep lab systems validated and controlled.
Validation and IT teams work through Part 11 controls, access management, and change control for the systems that generate study data.
Workflow friction
- Unvalidated spreadsheets holding study data
- Shared logins hiding who did what
- Changes deployed without assessment
How the program helps
- Validation protocols labs can execute
- Access review routines that scale
- Change control that protects data
Practice use cases
- IQ OQ PQ
- Access reviews
- Change control
Departments shown are illustrative; we tailor cohort grouping to your organization chart.
Prerequisites: This program benefits lab, QA, and study staff who generate, review, or approve study data. Familiarity with laboratory workflows helps but is not required, and no prior GLP certification experience is needed. We adapt examples and labs to each cohort's study types and systems.
Study Personnel to GLP Data Integrity Lead
Tracks how laboratory teams progress from basic ALCOA+ awareness to advanced inspection-ready documentation across the program's learn, practice, and apply phases.
A program that grows with laboratory careers, from first ALCOA+ record to confident inspection readiness.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Instructor-led sessions mix live instruction with guided labs in every delivery mode, tuned to your team's schedule.
Hybrid Training
Instructor-led sessions mix onsite and virtual delivery with guided labs throughout. Teams practice ALCOA+ classification, records lifecycle control, and mock inspections while the instructor coaches live. Hybrid keeps scheduling flexible without losing live interaction.
- Live instruction across onsite and virtual sessions
- Guided labs with instructor coaching and record reviews
- Real study documentation workflows throughout
- Flexible scheduling without losing live interaction
Onsite Training
The instructor runs the full program at your offices, with labs built around your SOPs, record templates, and system workflows for a realistic practice environment.
- Full program delivered at your offices
- Labs built around your SOPs and templates
- In-person coaching during every practice session
- Team-specific scenarios drawn from your studies
Live Virtual Training
Live virtual training runs on Zoom or Teams with the same guided labs and instructor coaching as onsite delivery, using demo systems and shared templates for every exercise.
- Live instructor-led sessions on Zoom or Teams
- Guided labs with screen-shared coaching
- Same exercises and templates as onsite delivery
- Batch scheduling across time zones
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, timelines, and delivery preference, and we will send a detailed per-group quote with batch options.
Yes. Book a discovery call and we will map your study types, systems, and goals to a tailored training plan before you commit.
Yes. Live virtual sessions run on Zoom or Teams with the same guided labs and instructor coaching as onsite delivery.
Yes. The instructor runs the full program at your offices, with labs built around your SOPs, templates, and workflows.
The program runs 24 hours across six modules, including a 5-hour capstone integrity assessment.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Laboratory data is often where regulated quality evidence starts, so GLP and ALCOA+ come first in this path. Your team then carries the same principles into manufacturing, uses CAPA when things go wrong, and validates the computerised systems that hold the records.
Why Choose Edstellar as Your Good Laboratory Practice (GLP) and Data Integrity (ALCOA+) Corporate Training Provider
Edstellar designs this program around your studies and systems, pairing regulatory clarity with hands-on practice so your team's records stand up to inspection.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Every cohort's labs, record templates, and scenarios are tuned to your study types, SOPs, and lab systems.
Proven Methodology
Concise instruction followed by guided labs and reviews, a repeatable method that turns regulations into lab habits.
Practice-Based Learning
Six guided labs move teams from ALCOA+ grading to system configuration to a full capstone assessment.
Expert Trainers
Practitioners who run GLP studies and quality systems coach every lab and review every capstone report.
Global Scale
Batches scheduled across sites and time zones keep multi-location lab teams on one documentation standard.
Measurable Outcomes
Lab reviews and the capstone assessment benchmark each team's documentation quality before and after.
Build GLP Data Integrity Through Record Review and Lifecycle Evidence
Edstellar connects GLP requirements and ALCOA+ principles with the records generated during a study. Participants trace data lifecycles, examine audit trails, and work through computerized-system and deviation scenarios. The final assessment reviews a complete study package, testing whether findings, corrective actions, and supporting evidence remain consistent from creation through retrieval.
- Step 01
Consult
We review laboratory workflows and difficulties with record corrections, audit trails, or data-integrity deviations, identifying the generation, review, and approval responsibilities represented in the cohort.
- Step 02
Plan
GLP foundations and ALCOA+ assessment lead into data lifecycle controls, computerized systems, and deviation handling before the complete study data-integrity assessment.
- Step 03
Align
We align laboratory quality and data-integrity expertise with lab, QA, and study roles, confirming relevant study types and suitable mock systems for controlled practice.
- Step 04
Customize
Sample study records and audit trails reflect familiar laboratory activities, allowing access, signature, and validation exercises without exposing confidential research or personal information.
- Step 05
Execute
Participants assess records, review audit trails, and triage deviations, receiving feedback on controlled corrections, traceability, system validation evidence, and the rationale for CAPA choices.
- Step 06
Evaluate
We assess the study findings report for evidence-backed ALCOA+ judgments, traceable lifecycle controls, justified deviation priorities, and corrective actions linked to the documented causes.
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Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Good Laboratory Practice (GLP) & Data Integrity (ALCOA+) Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Good Laboratory Practice (GLP) and Data Integrity (ALCOA+) Training for Your Team
Share your team size, study types, lab systems, and timelines to receive a tailored training plan and quote. Book a discovery call to discuss your goals; we confirm availability and respond with a proposal.