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Auditors Think.

Simulation-driven modules for pharmacologists, regulatory specialists, and QA teams — mapped to FDA, ICH, and GPhC frameworks. Below is your actual dashboard.

Pharmacovigilance · Module 7

ICH E6(R2) Addendum

12 min remaining

0%
1.5
CEU Credits
24
Questions
ICH Q10
GMP Level
Track Modules1/3 Done
7

ICH E6(R2) Addendum

12 min remaining

CIOMS Form Completion

28 min remaining

Signal Detection Methods

Completed

Study Streak
14days
Recertification
47days left

GPhC CPD Deadline: 04/15/2026

Quick Assessment

GMP Deviation Scenario — ICH Q10 §3.2

During a routine batch release, you discover an OOS result on a critical quality attribute. The investigation reveals a single analyst error. What is the correct first action?

a.Validate the CAPA before CAPA owner sign-off
b.Immediately escalate to the QP for batch recall
c.Document in the Deviation Log and assign root-cause owner
d.Close the deviation without follow-up if minor
Cohort Rank
#1

Priya Nair

98
#2

James Okonkwo

94
#3

You

91
#4

Sofia Reyes

88
Live Regulatory Update

FDA issued Draft Guidance on AI/ML-Based SaMD — Module 4 updated with new submission criteria.

ICH E6(R2)·GMP Compliance·21 CFR Part 11·NAPLEX Prep·FDA 483 Response·eCTD Submissions·GPhC CPD·RAPS RAC·CAPA Management·Pharmacovigilance·IND Applications·ACPE Accredited·ICH E6(R2)·GMP Compliance·21 CFR Part 11·NAPLEX Prep·FDA 483 Response·eCTD Submissions·GPhC CPD·RAPS RAC·CAPA Management·Pharmacovigilance·IND Applications·ACPE Accredited·
— Course Catalog

Validated Curriculum.
No Filler.

Every module maps to a real regulatory framework — ICH, FDA, EMA. Hover a card to see exactly what you'll be able to do when you finish.

PV-201Advanced

ICH E6(R2) GCP — Full Addendum

Pharmacovigilance
4.5
CEU
4.5 hrs
Duration
3,847
Hover to preview →
Learning Outcomes
  • Apply GCP principles to Phase III trial design
  • Identify 12 critical addendum deviations
  • Draft a protocol deviation CAPA report
Accreditation

ACPE / GPhC

RA-105Intermediate

eCTD Module 2.7 Submission

Regulatory Affairs
3.0
CEU
3 hrs
Duration
2,103
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Learning Outcomes
  • Structure a compliant CTD module 2.7.4 summary
  • Validate eCTD backbone using FDA gateway criteria
  • Navigate the eCTD lifecycle management
Accreditation

RAPS / DIA

QA-310Expert

GMP Audit Simulation

Quality Assurance
6.0
CEU
6 hrs
Duration
1,562
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Learning Outcomes
  • Lead a mock FDA 483 observation response
  • Apply ICH Q10 PQS to deviation management
  • Prepare a Site Master File (SMF) audit trail
Accreditation

ASQ / ISPE

NX-401All Levels

NAPLEX Blueprint Prep

Licensure Exam
12.0
CEU
12 hrs
Duration
9,214
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Learning Outcomes
  • Master all 3 NAPLEX competency areas
  • Complete 400+ adaptive practice questions
  • Review clinical pharmacokinetics for counseling
Accreditation

NABP / ACPE

CS-220Intermediate

Clinical Trial Statistics

Clinical Research
5.0
CEU
5 hrs
Duration
1,889
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Learning Outcomes
  • Interpret p-values and confidence intervals in trial reports
  • Apply ICH E9(R1) estimand framework
  • Evaluate adaptive trial design trade-offs
Accreditation

ACRP / SoCRA

— Simulation Engine

GMP Audit.
Live Walkthrough.

Click through a real FDA 483 deviation scenario. Each step reveals the regulatory rationale your QA team needs to know before the audit clock runs out.

Walkthrough Progress0/4
STEP 01Critical

Receive FDA 483 Observation

21 CFR 211.192

Scenario

An investigator issues Observation #3: "Inadequate investigation of OOS result for Batch #PF-2024-0891."

— Regulatory Accreditation

Credits That Count
Where It Matters.

Every hour you spend on Pharma maps to a real credential body. Click any badge to verify accreditation status and see which modules qualify.

6
Accrediting Bodies
32
Countries Recognized
180+
CEU Hours Available
47,200+
Active Certificates Issued
ACPE

ACPE

United States

CPE Provider

Accreditation Council for Pharmacy Education

Since

2019

Renewal

Annual

Verified

Pharma is an ACPE-accredited CPE provider. All pharmacovigilance and NAPLEX modules qualify for continuing pharmacy education credit.

Qualifying Modules
NAPLEX Blueprint PrepICH E6(R2) GCPClinical Trial Statistics
ACPE-0512-9876-23
RAPS

RAPS

Global

RAC Maintenance

Regulatory Affairs Professionals Society

Since

2020

Renewal

Biennial

Verified

Regulatory submissions modules qualify for RAC (Regulatory Affairs Certification) maintenance credits through the RAPS continuing education program.

Qualifying Modules
eCTD Module 2.7 SubmissionFDA 505(b)(2) PathwayIND Application Walkthrough
RAPS-EDU-4421-PH
GPhC

GPhC

United Kingdom

CPD Provider

General Pharmaceutical Council

Since

2021

Renewal

Annual

Verified

GPhC registrants can record completed Pharma modules as structured CPD entries directly aligned with GPhC Standards for Pharmacy Professionals.

Qualifying Modules
GMP Audit SimulationICH E6(R2) GCPClinical Trial Statistics
GPHC-CPD-8834-2026
ISPE

ISPE

Global

PDH Credits

International Society for Pharmaceutical Engineering

Since

2022

Renewal

Annual

Verified

QA/QC simulation modules qualify for Professional Development Hours (PDH) through ISPE, applicable to engineering and manufacturing compliance roles.

Qualifying Modules
GMP Audit SimulationeCTD Module 2.7 Submission
ISPE-PDH-2290-PH
ACRP

ACRP

Global

CRA/CRC Maintenance

Association of Clinical Research Professionals

Since

2021

Renewal

Biennial

Verified

Clinical research modules qualify for ACRP continuing education units toward CCRA and CCRC certification maintenance.

Qualifying Modules
Clinical Trial StatisticsICH E6(R2) GCP
ACRP-CE-5512-PH
NABP

NABP

United States

NAPLEX Prep

National Association of Boards of Pharmacy

Since

2019

Renewal

Annual

Verified

The NAPLEX Blueprint Prep module is developed in alignment with NABP competency statements and the 2025 NAPLEX Blueprint specifications.

Qualifying Modules
NAPLEX Blueprint Prep
NABP-PREP-7712-23
52,000+
Active Learners
1.4M
Modules Completed
94.2%
Pass Rate (NAPLEX)
98.7%
Audit Success Rate
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21 CFR Part 11 Compliant
SOC 2 Type II Certified
SCORM 1.2 & xAPI Compatible
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