Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378

Advanced applied program for implementing, auditing, improving, and preparing for certification or accreditation under Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378.

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Practical Learning

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days

5 Days

Language

English / Arabic

Course Summary

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Course Details

Overview

The "Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378" course is an advanced applied training program designed to enable participants to understand, implement, audit, and improve the requirements and practical controls of the Quality Management System for Primary Packaging Materials for Medicinal Products (PPM-QMS) in line with ISO 15378 and relevant international management-system practices.

The program connects the standard with real organizational needs by explaining how pharmaceutical and medical product packaging quality supports governance, operational control, risk reduction, stakeholder confidence, regulatory alignment, and sustainable performance. It is designed for organizations operating in pharmaceutical packaging manufacturers, medical device packaging suppliers, printing and labeling providers, plastic and glass packaging manufacturers, and quality departments, with special attention to practical implementation in Saudi and regional business environments.

Participants move from the foundation concepts of pharmaceutical and medical product packaging quality to the detailed management-system cycle: understanding the organization and interested parties, defining the system scope, leadership commitments, policy development, planning actions for risks and opportunities, resource and competence management, operational control, performance evaluation, internal auditing, management review, nonconformity handling, corrective action, and continual improvement.

The course gives strong practical coverage of GMP principles, contamination control, traceability, validation, risk management, supplier qualification, batch records, change control, deviation handling, internal auditing, and certification readiness. It also explains how the system can be integrated with other ISO management systems through the harmonized structure, how documented information should be controlled, how evidence should be maintained, and how the organization should prepare for first-stage and second-stage certification audits.

The program is intentionally practical and workshop-driven. Participants work on gap analysis, process mapping, risk registers, policy and procedure drafting, KPI design, audit checklists, mock audits, nonconformity statements, corrective-action plans, and a final case study based on a packaging manufacturer supplying primary packaging materials to pharmaceutical or medical product producers.

The standard delivery is a comprehensive 5-day program of 25 training hours. A condensed 3-day version can be delivered for experienced groups that already understand the previous version of the standard or need focused implementation and audit readiness.

Objectives

Program Objectives

By the end of this course, participants will be able to:

Explain the purpose, scope, structure, terminology, and implementation logic of ISO 15378, including its relationship with the harmonized structure used across modern ISO management systems.
Interpret the requirements of the Quality Management System for Primary Packaging Materials for Medicinal Products and translate them into practical obligations, responsibilities, controls, documented information, and measurable actions inside the organization.
Conduct a structured gap analysis to compare the current organizational practices against ISO 15378 requirements, classify gaps by priority, and prepare an implementation or transition action plan.
Design or update core management-system documentation, including policies, objectives, process maps, procedures, forms, registers, evidence records, monitoring plans, and control mechanisms.
Apply risk-based thinking to identify risks, opportunities, legal or compliance obligations, operational controls, stakeholder expectations, and measurable improvement priorities relevant to pharmaceutical and medical product packaging quality.
Plan and perform internal audits in line with ISO 19011 principles, including audit program planning, checklist preparation, evidence collection, audit reporting, nonconformity grading, and follow-up of corrective actions.
Measure system performance using relevant KPIs such as batch rejection rate, contamination incidents, deviation closure time, supplier qualification status, validation completion, complaint rate, traceability-test results, and audit findings, analyze results, identify trends, and recommend practical improvement actions.
Prepare the organization for certification or accreditation readiness by understanding certification stages, surveillance audits, recertification, transition planning, management review outputs, and continual improvement evidence.

Target Audience

Managers and supervisors responsible for pharmaceutical and medical product packaging quality in public, private, industrial, service, and non-profit organizations.
Management-system officers, quality officers, compliance officers, risk officers, operational excellence teams, and internal audit teams involved in implementing Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378.
Consultants, auditors, lead implementers, and practitioners who support organizations in establishing, maintaining, integrating, or improving ISO management systems.
Operations, production, maintenance, procurement, safety, environment, customer service, laboratory, facility, sustainability, or sector-specific managers whose processes are affected by the Quality Management System for Primary Packaging Materials for Medicinal Products.
Executives and department heads who need a practical understanding of governance, responsibilities, performance indicators, management review, and certification readiness.
Employees nominated to join the implementation team, documentation team, risk assessment team, internal audit team, or certification preparation team.
Graduates and professionals seeking to specialize in ISO standards, management systems, internal auditing, operational governance, and professional consulting.
Organizations preparing for initial certification, transition to a new version, surveillance audit, recertification audit, or integration with ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 37301, or other standards.

Competencies

Core Competencies

ISO 15378 Gap Analysis

Use structured checklists to assess the current PPM-QMS against standard requirements, identify nonconformities and improvement opportunities, prioritize gaps, and prepare a practical action plan.

Management-System Documentation

Develop and control policies, objectives, procedures, process maps, registers, forms, records, and evidence needed to demonstrate effective implementation of the Quality Management System for Primary Packaging Materials for Medicinal Products.

Risk and Opportunity Assessment

Identify internal and external issues, interested parties, compliance obligations, operational risks, opportunities, controls, responsibilities, and monitoring methods relevant to pharmaceutical and medical product packaging quality.

Operational Control and Process Management

Translate requirements into daily operational controls, workflow responsibilities, competence requirements, communication routines, supplier controls, and documented evidence.

Performance Measurement and Data Analysis

Design dashboards and KPIs such as batch rejection rate, contamination incidents, deviation closure time, supplier qualification status, validation completion, complaint rate, traceability-test results, and audit findings, analyze trends, determine root causes, and link findings with corrective actions and improvement projects.

Internal Audit and Certification Readiness

Plan and conduct internal audits according to ISO 19011, collect objective evidence, write audit findings, classify nonconformities, lead closing meetings, follow up corrective actions, and prepare for certification audits.

Management Review and Continual Improvement

Prepare management review inputs and outputs, evaluate resource needs and system effectiveness, document leadership decisions, and convert review outputs into measurable improvement actions.

Learning Journey

Program Outline

Day 1: Foundations of Pharmaceutical And Medical Product Packaging Quality and Introduction to Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378

Introduction to Quality Management System for Primary Packaging Materials for Medicinal Products

Definition, purpose, benefits, scope, business value, governance role, and the way the PPM-QMS supports consistent performance, stakeholder confidence, and operational discipline.

Evolution and structure of ISO 15378

Overview of the ISO family, relevant versions, terminology, high-level or harmonized structure, PDCA logic, relationship with other ISO standards, and key clauses or guidance principles.

Context of the organization

How to identify internal and external issues, interested parties, stakeholder needs, legal and regulatory expectations, contractual obligations, and system boundaries.

Leadership, policy, roles, and responsibilities

Leadership commitment, accountability, policy development, communication of responsibilities, culture building, and assignment of authorities for system effectiveness.

Practical workshop: organizational context analysis

Participants work in groups to analyze the context of a packaging manufacturer supplying primary packaging materials to pharmaceutical or medical product producers, identify stakeholders, map compliance obligations, and connect the analysis to risks, opportunities, objectives, and system scope.

Day 2: Planning, Risk-Based Thinking, Objectives, and Documented Information for ISO 15378

Risk and opportunity planning

Identifying risks and opportunities related to pharmaceutical and medical product packaging quality, determining controls, assigning responsibilities, evaluating effectiveness, and integrating actions into processes.

Objectives, targets, and action plans

How to write SMART objectives, define owners, resources, timelines, evaluation methods, baseline measures, improvement priorities, and alignment with organizational strategy.

Documented information control

Document approval, version control, distribution, retrieval, retention, disposal, protection of records, electronic document management, and evidence required during audits.

Competence, awareness, and communication

Competence requirements, training plans, awareness messages, internal and external communication, communication matrix, and evidence of competence and understanding.

Practical workshop: risk register and objectives matrix

Participants prepare a risk register, compliance-obligation register, objectives matrix, responsibilities matrix, and implementation timeline for a packaging manufacturer supplying primary packaging materials to pharmaceutical or medical product producers.

Day 3: Operational Implementation and Control of the Quality Management System for Primary Packaging Materials for Medicinal Products

Process approach and operational control

Defining core, support, and management processes; mapping inputs and outputs; defining process owners; setting control criteria; and maintaining operational evidence.

Implementation of standard-specific controls

Detailed applied discussion of GMP principles, contamination control, traceability, validation, risk management, supplier qualification, batch records, change control, deviation handling, internal auditing, and certification readiness, including how to convert requirements into procedures, checklists, workflows, controls, records, and monitoring routines.

Supplier, contractor, and outsourced process control

Criteria for selection, evaluation, re-evaluation, contractual controls, performance monitoring, communication of requirements, and handling external-provider nonconformities.

Emergency, incident, and nonconformity handling

Identification, containment, communication, investigation, correction, corrective action, escalation, lessons learned, and evidence needed to prove effective closure.

Practical workshop: process map and control plan

Participants design a process map, control points, records, responsibilities, and monitoring methods for the selected case study: a packaging manufacturer supplying primary packaging materials to pharmaceutical or medical product producers.

Day 4: Performance Evaluation, Internal Audit, Management Review, and Improvement

Monitoring, measurement, analysis, and evaluation

Selection of valid monitoring methods, data collection, analysis, evaluation, reporting, dashboards, and KPIs such as batch rejection rate, contamination incidents, deviation closure time, supplier qualification status, validation completion, complaint rate, traceability-test results, and audit findings.

Internal auditing according to ISO 19011

Audit principles, annual audit program, audit scope and criteria, auditor competence, independence, audit plan, opening meeting, evidence collection, interviews, sampling, findings, and closing meeting.

Writing nonconformities and corrective actions

How to write clear nonconformity statements, reference clauses, distinguish correction from corrective action, perform root cause analysis, and verify effectiveness.

Management review

Inputs, outputs, decisions, resource needs, improvement opportunities, changes in context, audit results, customer or stakeholder feedback, KPI performance, and documentation of meeting minutes.

Practical workshop: mock internal audit

Participants prepare an audit checklist, conduct a mock audit, record at least one major nonconformity, one minor nonconformity, and one opportunity for improvement, then prepare an audit report.

Day 5: Integration, Digital Enablement, Certification Readiness, and Final Case Study

Integrated management systems

How to integrate policies, objectives, risk registers, document control, competence, communication, internal audit, management review, corrective action, and improvement across multiple ISO systems.

Digital transformation and data governance

Use of ERP, electronic document management, dashboards, mobile checklists, digital audit tools, automated alerts, data integrity controls, cybersecurity considerations, and analytics.

Certification or accreditation readiness

Selecting a certification or accreditation body, preparing for stage 1 and stage 2 audits, handling surveillance audits, recertification, transition planning, audit logistics, and employee readiness.

Integrated case study and implementation plan

Participants prepare a full implementation or transition plan for a packaging manufacturer supplying primary packaging materials to pharmaceutical or medical product producers, including gap analysis, policies, objectives, risks, processes, KPIs, audit schedule, resources, timeline, and estimated cost.

Final assessment and course review

Objective questions, scenario analysis, clause identification, corrective-action writing, group discussion, review of key lessons, and confirmation of next steps for implementation.

Enrollment Summary

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Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378

Certificate Included

Expert-Led Training

Practical Learning

Enrollment Support

days

5 Days

Language

English / Arabic

Overview

Program Objectives

By the end of this course, participants will be able to:

Explain the purpose, scope, structure, terminology, and implementation logic of ISO 15378, including its relationship with the harmonized structure used across modern ISO management systems.
Interpret the requirements of the Quality Management System for Primary Packaging Materials for Medicinal Products and translate them into practical obligations, responsibilities, controls, documented information, and measurable actions inside the organization.
Conduct a structured gap analysis to compare the current organizational practices against ISO 15378 requirements, classify gaps by priority, and prepare an implementation or transition action plan.
Design or update core management-system documentation, including policies, objectives, process maps, procedures, forms, registers, evidence records, monitoring plans, and control mechanisms.
Apply risk-based thinking to identify risks, opportunities, legal or compliance obligations, operational controls, stakeholder expectations, and measurable improvement priorities relevant to pharmaceutical and medical product packaging quality.
Plan and perform internal audits in line with ISO 19011 principles, including audit program planning, checklist preparation, evidence collection, audit reporting, nonconformity grading, and follow-up of corrective actions.
Measure system performance using relevant KPIs such as batch rejection rate, contamination incidents, deviation closure time, supplier qualification status, validation completion, complaint rate, traceability-test results, and audit findings, analyze results, identify trends, and recommend practical improvement actions.
Prepare the organization for certification or accreditation readiness by understanding certification stages, surveillance audits, recertification, transition planning, management review outputs, and continual improvement evidence.

Target Audience

Managers and supervisors responsible for pharmaceutical and medical product packaging quality in public, private, industrial, service, and non-profit organizations.
Management-system officers, quality officers, compliance officers, risk officers, operational excellence teams, and internal audit teams involved in implementing Quality Management System for Primary Packaging Materials for Medicinal Products - ISO 15378.
Consultants, auditors, lead implementers, and practitioners who support organizations in establishing, maintaining, integrating, or improving ISO management systems.
Operations, production, maintenance, procurement, safety, environment, customer service, laboratory, facility, sustainability, or sector-specific managers whose processes are affected by the Quality Management System for Primary Packaging Materials for Medicinal Products.
Executives and department heads who need a practical understanding of governance, responsibilities, performance indicators, management review, and certification readiness.
Employees nominated to join the implementation team, documentation team, risk assessment team, internal audit team, or certification preparation team.
Graduates and professionals seeking to specialize in ISO standards, management systems, internal auditing, operational governance, and professional consulting.
Organizations preparing for initial certification, transition to a new version, surveillance audit, recertification audit, or integration with ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 37301, or other standards.

Core Competencies