Tracks Curriculum Employers Take Exam Enroll

Certified Pharma
Data Integrity
Specialist

The industry credential for data integrity professionals

FDA 21 CFR Part 11 ALCOA+ GAMP 5 EU GMP Annex 11 ICH Q10

Why Get Certified

Stand apart in a regulated industry

▲

Career Growth

Differentiate yourself in a competitive market. Certified professionals earn 25-40% more than non-certified peers in pharma data integrity roles. Open doors to senior validation, compliance, and QA leadership positions.

◆

Employer Value

Reduce compliance risk across your organisation. Certified teams close FDA observations 3x faster and prevent costly warning letters. Lower your total cost of regulatory compliance.

●

Industry Recognition

Recognised by top pharmaceutical companies and CROs worldwide. The CPDIS credential signals deep expertise in electronic records, audit trails, and data integrity to regulators and employers alike.

Certification Tracks

Choose your path to mastery

Level 1

Foundation

$750
8 modules 18 hours of content 4 weeks, self-paced Online delivery
  • FDA 21 CFR Part 11 fundamentals
  • ALCOA+ principles deep dive
  • Audit trail design and review
  • Electronic records and signatures
  • EU GMP Annex 11 and global standards
  • Data integrity risk assessment
  • Certification exam included
Enroll Now
Most Popular Level 2

Practitioner

$5,000
12 modules + hands-on labs 33 hours of content 8 weeks Online + hands-on with Nessa Prerequisite: Foundation
  • Computer System Validation framework
  • IQ/OQ/PQ protocol development and execution
  • Hands-on validation using Nessa platform
  • SOP development for GxP systems
  • FMEA risk assessment workshop
  • FDA warning letter case studies
  • Practitioner certification exam
Enroll Now
Level 3

Expert

$10,000
16 modules + capstone project 57 hours of content 12 weeks Online + mentorship + capstone Prerequisite: Practitioner
  • Regulatory strategy and FDA engagement
  • FDA inspection prep and mock audits
  • System validation program leadership
  • Advanced cryptographic data integrity
  • Multi-site validation strategy
  • ML for compliance monitoring
  • Capstone: full system validation
  • 3 one-on-one mentorship sessions
  • Expert certification exam and defense
Enroll Now

Curriculum Preview

What you will learn

Level 1

Foundation

  • F01Introduction to Pharmaceutical Data Integrity2 hrs
  • F02FDA 21 CFR Part 11 Requirements3 hrs
  • F03ALCOA+ Principles Deep Dive3 hrs
  • F04Electronic Records and Signatures2 hrs
  • F05Audit Trail Design and Review3 hrs
  • F06Data Integrity Risk Assessment2 hrs

Level 2

Practitioner

  • P01Computer System Validation (CSV) Framework3 hrs
  • P02GAMP 5 Categories and Risk-Based Approach3 hrs
  • P03IQ/OQ/PQ Protocol Development4 hrs
  • P04Hands-On: Executing Validation with Nessa4 hrs
  • P05SOP Development for GxP Systems3 hrs
  • P06FMEA Risk Assessment Workshop3 hrs

Level 3

Expert

  • E01Regulatory Strategy and FDA Engagement4 hrs
  • E02FDA Inspection Preparation and Mock Audits5 hrs
  • E03System Validation Program Leadership4 hrs
  • E04Advanced Cryptographic Data Integrity3 hrs
  • E05GDPR and HIPAA for Life Sciences3 hrs
  • E14Capstone Project: Full System Validation10 hrs

For Employers

Train your team

Invest in your workforce with group certification programmes. Certified teams reduce validation timelines, prevent regulatory findings, and build a culture of data integrity excellence.

  • Group pricing for 5+ participants
  • On-site workshops: $25K - $50K per engagement
  • Custom curriculum tailored to your systems
  • Dedicated account manager and progress tracking
  • Annual recertification and continuing education
60%
Faster Validation
3x
Faster FDA Responses
85%
Fewer Observations
$2M+
Avg. Risk Reduction

Testimonials

What our alumni say

Testimonials coming soon as our first cohort completes certification.

Begin your certification

Join the next generation of pharma data integrity professionals. Enroll today and gain the credential that regulators and employers trust.

Enroll Now

Certification Exam

Take your exam

Select your certification level and begin the proctored exam. You will have one attempt per session. Answer all questions before submitting.

Question 1 of 30
Loading questions...