ISO 15378:2017 Lead Auditor Training Course

The ISO 15378:2017 Lead Auditor Training is a comprehensive professional program designed to build the competence required to audit quality management systems for manufacturers of primary packaging materials used in pharmaceutical products. The training focuses on the practical application of ISO 15378:2017 requirements, combining Good Manufacturing Practices with ISO-based management system principles to ensure regulatory alignment and product safety.

5 Days
Beginner
Classroom
Flexible Dates

About this training

Primary Packaging Materials for Medicinal Products


From planning and managing audit programmes to evaluating performance and reporting outcomes, this lead auditor training course equips participants with the knowledge and skills required to audit quality management systems for primary packaging materials used in pharmaceutical products.


Delivered over five intensive days by experienced industry practitioners, the course is designed for professionals involved in pharmaceutical packaging, quality assurance, compliance, and regulatory oversight. It enables participants to understand the integration of GMP principles with ISO-based management systems and the critical role of the auditor in ensuring product safety and regulatory compliance.


Upon successful completion, participants will be capable of applying risk-based thinking, process-oriented auditing, and regulatory awareness when conducting ISO 15378 audits across the pharmaceutical packaging supply chain.


How will I benefit?


By attending this training, you will be able to:


  1. Understand the objectives and value of auditing against ISO 15378:2017
  2. Plan, conduct, and close audits for primary packaging material manufacturers
  3. Interpret GMP requirements within a quality management system framework
  4. Strengthen confidence among regulators, customers, and internal stakeholders
  5. Enhance professional competence through structured audit methodologies


What will I learn?


On completion of this course, participants will be able to:


  1. Plan, conduct, report, and follow up audits in line with ISO 19011 auditing guidelines
  2. Understand the structure, intent, and key requirements of ISO 15378:2017
  3. Evaluate compliance with GMP principles applicable to pharmaceutical packaging materials
  4. Apply risk-based auditing techniques and process-based approaches
  5. Communicate audit findings clearly and effectively to management and stakeholders


Who should attend?


This course is suitable for:


  1. Quality professionals working in pharmaceutical and packaging industries
  2. GMP and compliance managers
  3. Quality assurance and quality control personnel
  4. Packaging engineers and technical specialists
  5. Consultants supporting pharmaceutical packaging compliance
  6. Professionals seeking to perform first-party, second-party, or third-party audits


What’s included?


  1. Live virtual classroom sessions delivered by expert tutors
  2. Interactive discussions, case studies, and practical audit exercises
  3. Access to digital training materials and reference documents
  4. Online examination conducted via a secure e-assessment platform
  5. Remote invigilation through webcam and microphone