ISO 15378 2017 Primary packaging materials for medicinal products - Internal Auditor Course
Instructor
QGLOBAL ACADEMY
633
Students
enrolled
- Description
- Curriculum
ISO 15378:2017 primary packaging materials for medicinal products identifies good manufacturing practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry. ISO 15378 2017 internal auditor course will help you learn how to initiate an audit, prepare and conduct audit activities, compile and distribute audit reports and complete follow-up activities. On successful completion of this course, you will be able to optimize your auditing skills with the internationally recognized ISO 15378 2017 standard and boost your audit capabilities. Also gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary. ISO 15378 2017 internal auditor training course develops the necessary skills to assess and report on the conformance and implementation of processes based on ISO 15378 2017 standard.
Who Should Attend?
- Anyone involved in the planning, implementing, maintaining, supervising or auditing of an ISO 15378 2017 quality management system
- Those who like to handle the role of an ISO 15378 2017 internal auditor in an organisation
- Employees of any organisation who wish to audit their organisation’s quality management system
- Those involved in second party audits such as vendor audits
- Personnel who wish to pursue career as an ISO 15378 2017 internal auditor
- Expert advisors in quality management
Key Benefits
- Develop the career as an ISO 15378 2017 quality management system lead auditor
- Become ISO 15378 2017 freelance lead auditor
- Gain the skills to plan, conduct, report and follow up first, second and third party audits in accordance with ISO 19011 standard
- Learn skills to lead an audit team
- Identify the aims and benefits of an ISO 15378 2017 audit
- Interpret ISO 15378 2017 requirements for audit application
- Grasp the application of risk-based thinking, leadership and process management
- Acknowledge the correlation between ISO 15378 2017 and other standards and regulatory frameworks
- Learn the latest ISO 15378 2017 lead auditor techniques
- Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business
- Learn to audit the GMP requirements for printed primary packaging materials
- Fill gaps in your professional knowledge
Learning & Evaluation Method
This is a live and interactive course. Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.
Certification
There are increasing numbers of organizations, who prefer candidates those who have completed management system trainings from a recognized institution. Certification demonstrates your commitment to superior professionalism, upholding industry standards, and continued learning. These merits can help boost your professional credibility and prestige within your own network, in your organisation, with your current clients, and when pursuing new business opportunities. After the successful completion of the course and final exam, you will be awarded with a certificate of completion issued by QGlobal. Your credentials will be made available in the global online directory and can be verified by anyone searching with the certificate number. Without doubt we can say that our training courses are well recognized and sought after by organizations across various geographies.
Sample Certificate
Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.
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Awareness training on ISO 15378 2017 standards
-
1
Introduction to standards and certification- Purpose of standardization
- Benefits of certification
-
2Introduction to ISO 15378 standards
- Introduction
- Compliance requirements
- Process approach
- Plan-Do-Check-Act (PDCA)
- Risk based thinking
- Benefits of ISO 15378 certification
- Quality management system principles
-
3Quality management system principles
- Fundamental concepts
- Quality management system principles
-
4ISO 15378 Context of the organization
- Understanding the organization and its context
- Understanding the needs and expectations of interested parties
- Determining the scope of the quality management system
- Quality management system and its processes
-
5ISO 15378 Leadership
- Leadership and commitment
- Policy
- Organizational roles, responsibilities and authorities
-
6ISO 15378 Planning
- Actions to address risks and opportunities
- Quality objectives and planning to achieve them
- Planning of changes
-
7ISO 15378 Support
- Resources
- Competence
- GMP-training
- Awareness
- Communication
- Documented information
- Creating and updating
- Control of documented information
- Administration of IT systems and data
-
8ISO 15378 Operation
- Operational planning and control
- Requirements for products and services
- Customer communication
- Determining the requirements for products and services
- Review of the requirements for products and services
- Changes to requirements for products and services
- Design and development of products and services
- Design and development planning
- Design and development inputs
- Design and development controls
- Design and development outputs
- Design and development changes
- Control of externally provided processes, products and services
- Type and extent of control
- Information for external providers
- Production and service provision
- Control of production and service provision
- Cleanliness of product and contamination control
- Identification and traceability
- Property belonging to customers or external providers
- Preservation
- Post-delivery activities
- Control of changes
- Release of products and services
- Control of nonconforming outputs
-
9ISO 15378 Performance evaluation
Monitoring, measurement, analysis and evaluation
Customer satisfaction
Analysis and evaluation
Investigation of OOS results
Incoming inspection and testing
In-process controls
Batch release
Retained samples
Process data
Internal audit
Management review
Manag ement review inputs
Management review outputs
-
10ISO 15378 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Internal auditor training on ISO 15378 2017 standards
-
11Introduction to ISO 19011 2018 Guidelines for auditing management systems
- Scope
- Normative references
- Terms and definitions
-
12ISO 19011 Principles of auditing
-
13ISO 19011 Managing an audit program
- Establishing audit programme objectives
- Determining and evaluating audit programme risks and opportunities
- Establishing the audit programme
- Roles and responsibilities of the individual(s) managing the audit programme
- Competence of individual(s) managing audit programme
- Establishing extent of audit programme
- Determining audit programme resources
- Implementing audit programme
- Defining the objectives, scope and criteria for an individual audit
- Selecting and determining audit methods
- Selecting audit team members
- Assigning responsibility for an individual audit to the audit team leader
- Managing audit programme results
- Managing and maintaining audit programme records
- Monitoring audit programme
- Reviewing and improving audit programme
-
14ISO 19011 Conducting an audit
- Initiating audit
- Establishing contact with auditee
- Determining feasibility of audit
- Preparing audit activities
- Performing review of documented information
- Audit planning
- Assigning work to audit team
- Preparing documented information for audit
- Conducting audit activities
- Assigning roles and responsibilities of guides and observers
- Conducting opening meeting
- Communicating during audit
- Audit information availability and access
- Reviewing documented information while conducting audit
- Collecting and verifying information
- Generating audit findings
- Determining audit conclusions
- Conducting closing meeting
- Preparing and distributing audit report
- Preparing audit report
- Distributing audit report
- Completing audit
- Conducting audit follow-up
-
15ISO 19011 Competence and evaluation of auditors
- Determining auditor competence
- Personal behavior
- Knowledge and skills
- Achieving auditor competence
- Achieving audit team leader competence
- Establishing auditor evaluation criteria
- Selecting appropriate auditor evaluation method
- Conducting auditor evaluation
- Maintaining and improving auditor competence
-
16ISO 19011 Audit role plays
Course details
Duration
16 hr
Lectures
17
Level
Beginner
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