Regulated Science Institute

Free guide

Quality & Compliance guide

Every Quality & Compliance program at Regulated Science Institute in one place: who each program is for, what you will learn and how long it takes.

  • 4 programs
  • 50 hours of study
  • PDF to keep

How to use this guide

Start with the program closest to your current role, then add the ones your next role asks for. Each entry below lists who the program is written for and the skills you leave with, so you can compare them side by side. Every program ends with a digital certificate of completion you can add to LinkedIn.

Who it is for

IT, QA, and validation engineers who need to validate GxP systems using modern risk-based methods.

What you will learn

  • Determine intended use and risk level for a GxP software function
  • Choose a proportionate assurance activity and level of documentation
  • Write a lean validation plan and summary report
  • Assess a SaaS supplier for GxP use
  • Maintain a validated state through change control and periodic review
2

GxP Data Integrity Professional Certificate

About 10 hours · online, self-paced · certificate

Who it is for

QC analysts, QA reviewers, lab managers, and clinical data staff responsible for trustworthy GxP records.

What you will learn

  • Apply ALCOA+ to paper, hybrid, and electronic records
  • Perform a risk-based audit trail review
  • Identify common data integrity red flags in labs
  • Design a data governance program
  • Plan remediation after a data integrity finding

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3

Medical Device QMS: FDA QMSR and ISO 13485 Certificate Program

About 14 hours · online, self-paced · certificate

Who it is for

Quality engineers, QA specialists, and operations staff at medical device manufacturers and suppliers.

What you will learn

  • Explain the key differences between the QSR and the QMSR
  • Map an existing QMS to ISO 13485:2016 clauses
  • Link design controls with ISO 14971 risk management
  • Run complaint handling and CAPA processes that satisfy FDA
  • Plan and conduct an internal QMS audit
4

GMP Deviations, CAPA, and Inspection Readiness Professional Certificate

About 12 hours · online, self-paced · certificate

Who it is for

Manufacturing, QC, and QA staff who investigate deviations or prepare sites for regulatory inspections.

What you will learn

  • Classify and contain a GMP deviation
  • Lead a defensible root cause investigation
  • Write CAPAs with measurable effectiveness checks
  • Apply risk tools in change control decisions
  • Prepare a site and staff for an FDA or EU inspection
Regulated Science Institute
Programs
Regulatory Affairs 6
Clinical Operations 4
Quality & Compliance 4
Drug Safety & Pharmacovigilance 2
Market Access & HEOR 2
Data, AI & Real-World Evidence 2
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