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  • Preclinical & Laboratory Foundations
  • Phase I – First-in-Human Trials
  • Phase II & III – Efficacy & Pivotal Trials
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations - courses at £229
  • Good Laboratory Practice (GLP)
  • 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
  • OSHA Laboratory Safety Training
  • Laboratory Management Systems ISO/IEC 17025:2017
  • Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
  • Qualification Validation Training
  • Cleaning Validation
  • ISO 9001:2015 - Quality Management System for Pharmaceuticals

About

The Quality & Compliance Professional Learning Path is designed to provide a comprehensive, role-spanning quality management education for professionals working across pharmaceutical manufacturing, clinical operations, warehousing, and distribution environments. Covering ISO 9001:2015, ISO 13485 internal auditing, GMP principles, data integrity, deviation and non-conformance management, CAPA, quality risk management, cleaning validation, equipment qualification, warehouse practice, and clinical site quality foundations, this programme equips quality professionals with the breadth of knowledge required to build, maintain, and continuously improve quality management systems across regulated life sciences settings.

Participants will develop the skills to lead quality system implementation and auditing activities, investigate deviations and non-conformances effectively, manage CAPA programmes, apply risk-based quality tools aligned with ICH Q9, and maintain inspection-ready quality documentation — providing a complete operational quality competency framework from GMP basics through to advanced quality system management.

How this differs from the Medical Devices Regulatory Track

The Quality & Compliance Professional Learning Path is focused on quality management systems, GMP compliance, deviation management, CAPA, and validation across pharmaceutical manufacturing and clinical environments. It is designed for QA/QC professionals, compliance managers, and site quality leads in pharmaceutical and CRO settings.

In comparison, the Medical Devices Regulatory Track focuses specifically on the regulatory frameworks, risk management standards, and post-market surveillance obligations applicable to medical device manufacturers — covering EU MDR, ISO 13485, ISO 14971, and device vigilance. Both paths share quality management foundations but diverge significantly in their regulatory context and sector-specific requirements.

Courses Included

QMS Auditing & Inspection Readiness – ISO 13485:2016 Internal Auditor

Internal auditor qualification for ISO 13485:2016 — audit planning, execution, findings classification, reporting, and CAPA follow-up

duration3 hoursCPD points2 points
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Corrective Action and Preventive Action (CAPA) Training

CAPA system management — root cause analysis tools, action planning, effectiveness checks, and CAPA documentation for regulatory inspections

duration1 hoursCPD points3 points
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Quality Risk Management

ICH Q9 risk management principles — risk identification, FMEA, risk ranking, risk communication, and integration with pharmaceutical quality systems

duration1 hoursCPD points2 points
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Cleaning Validation

Cleaning validation strategy, acceptance criteria, sampling methods, lifecycle approach, and regulatory expectations under EU GMP Annex 15

duration2 hoursCPD points3 points
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Qualification Validation Training

Equipment and utility qualification — DQ, IQ, OQ, PQ stages, validation master plan, and lifecycle validation management

duration1 hoursCPD points2 points
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QMS Foundations for Clinical Sites

Quality management principles applied to investigator sites — SOPs, training frameworks, audit readiness, and clinical site CAPA management

duration2 hoursCPD points3 points
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Our Certified Customers

novartis
NHS
takeda
roche
baxter

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Frequently Asked Questions

  • Quality Assurance and Quality Control professionals in pharmaceutical manufacturing and CRO organisations
  • GMP compliance officers and quality managers
  • Internal auditors seeking ISO 13485:2016 qualification
  • Validation specialists responsible for equipment qualification and cleaning validation
  • Warehouse and distribution quality managers in GDP-regulated environments
  • Clinical site quality coordinators and QMS administrators
  • Regulatory affairs professionals with quality system responsibilities
  • Professionals transitioning into quality roles from manufacturing, laboratory, or clinical operations backgrounds
  • Life sciences graduates entering pharmaceutical quality and compliance functions

Upon completion of this learning path, participants will be able to implement and audit pharmaceutical quality management systems under ISO 9001:2015 and ISO 13485:2016, apply GMP principles and data integrity standards, manage deviations, non-conformances, and CAPA programmes effectively, conduct quality risk management using ICH Q9 tools, oversee cleaning validation and equipment qualification activities, and maintain compliant warehouse and clinical site quality operations across regulated life sciences environments.