ISO 15378 Certified Auditor Training

PAS140   Type: E-Learning

ISO 15378 Certification is a quality assurance of basic synthetic medical products, with respect to GMP. So, to learn about how to audit or implement a Quality Management System as well as the audit requirements to undertake internal audits as per ISO 15378:2017.

ISO 15378 Certified Auditor Training

Description

In pharmaceuticals and medical device industries, The ISO 15378:2017 certification purposes of primary packaging material for medicinal products. The web-based Certified ISO 15378 auditor training - online course is designed to provide online training and certification to become an internal auditor for ISO 15378:2017 Quality Management System. In this latest ISO 15378 training online course, you will learn everything you need to know about ISO 15378:2017 requirements and also how to perform an effective internal audit in your company. After successful completion of this ISO 15378 auditor online training course, the participants will gain knowledge and understanding of the quality management system audit, ISO 15378:2017 Internal audit records and get auto-generated ISO 15378 Certified Auditor Training Certificate online for trained ISO 15378 internal auditor.              

TOPICS COVERED: ISO 15378 INTERNAL AUDITOR TRAINING ONLINE

This Newly ISO 15378 internal auditor training includes a total of 07 interactive online sessions with combinations of lectures with audio-visual presentation and handouts as well as online exams to ensure a complete understanding of this subject.

  • Session - 1: Overview of ISO 15378:2017
  • Session - 2: ISO 15378:2017 requirements
  • Session - 3: ISO 15378:2017 Documented Information
  • Session - 4: ISO 15378:2017 Internal Management system audit
  • Session - 5: ISO 15378:2017 Internal audit records
  • Session - 6: Risk Management
  • Session - 7: Steps for ISO 15378:2017 Installation and Certification

Each of the above sessions consists of modules such as Audio lectures, hand-outs and session exams as well as one final exam as below:

  1. Lectures:
    There are 7 lectures of online sessions, which are given in this course as a presentation with explanatory audio and visuals to understand the subject well.
  2. Handouts:
    For all the above 7 online sessions, the hand-outs are given in more than a total of 156 pages in pdf format. The users of this course can download and save the handouts to their computer and print them or read them offline to get detailed knowledge of all the seven topics mentioned above.
  3. Exams:
    In this ISO 15378 internal auditor training course, the participant has to clear all 07 session's exams and one final exam as given in a separate section of the course. After successfully passing the final exam, an auto-generated ISO 15378 Auditor Training Certificate will be issued and can be downloaded and printed from the dashboard.
  4. Audit Checklists:
    The ISO 15378 Audit checklist - complete set of more than 350 audit questions as per ISO 15378:2017 standard requirement-wise as well as department-wise. The ISO 15378:2017 audit checklist also helps participants to prepare for the final audit.

COURSE OBJECTIVES

After completion of this ISO 15378 auditor training e-learning course, the user will be able to:

  • Familiarize yourself with ISO 15378 Requirements in detail.
  • Know about the resource requirements and process requirements.
  • Understand the documentation required by ISO 15
  • Understand documentation and list of procedures to be maintained, and to check them as internal auditor.
  • Get the knowledge of internal auditing and use of audit checklist.
  • Know about the types of auditing and questioning techniques.
  • Familiarize yourself with implementation of ISO 15378 Certified Auditor programs in detail.
  • Get the ready-to-use audit checklist with clause-wise questions to perform an effective audit.

WHO SHOULD ATTEND THIS COURSE?

  • Individuals who want to become ISO 15378 Internal Auditor
  • Individuals involved in the implementation of the management system within the organization.
  • Individuals having a basic knowledge of standard or working in the organization
  • Key personnel in the implementation within the organization
  • Other people who have found this course useful and who want to enhance their auditing knowledge and skills, and those looking to achieve formal recognition as certified ISO 15378  trained auditor.

Prerequisites for Enrol ISO 15378 Certified Auditor Course

  • Knowledge of Management systems and read the standard
  • Understand the Plan-Do-Check-Act (PDCA) cycle.
  • Knowledge of the GMP principles and concepts.
  • Knowledge of Quality Management System and read the standard.

AUTHORS & INSTRUCTORS

For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.

STUDY MATERIALS

This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.

EXAMINATION AND COURSE CERTIFICATE

This training program includes the Course Certificate that is issued upon course completion and passing the session exam as well as final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student to get this course certificate

END OF COURSE INSTRUCTION

After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.

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Why Learn with Us?

Why ISO Auditor Courses at Punyam Academy

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How to get Certified for Online ISO Auditor Course
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Blaizon C Mathai
Abu Dhabi, UAE

I would like to extend my sincere gratitude in introducing this program. Course material and presentations very valuable indeed and informative too. Even presentations made in simple language

Maria Garcia
California, USA

Great e-learning course by Punyam Academy, easy to use and learning can be done at your own pace. Material and content provided is exceptional. I would definitely recommend to anyone

Paul Thompson
South Africa

My first online course experience and it was pleasant to attend PAS102. I found the course to be very thorough and covered all aspects that are needed to carry out auditing.

Mary Smith
Dubai, UAE

The course has good information for new auditors or anyone that wants to be an internal auditor for understanding the standard. The content was very relevant, and the process of assessment required me to really understand the coursework

Nancy Lewis
South Africa

I was very happy to be able to complete the course online. I enjoyed being able to complete the course at my own pace. The support from Punyam Academy team has been great. Thanks!

Edward Anderson
California, USA

A valuable online opportunity to further skills and knowledge. Enrol for ISO/IEC 17025 auditor course, and fills best certified course in minimum cost

John Davis
Abu Dhabi, UAE

Excellent training at Punyam Academy, friendly atmosphere and lovely staff, highly recommended. Voice enable presentation gives me filling like live training, which saves my time.

Jennifer Nelson
UAE

Best place to go for ISO/IEC 17025:2017 Internal Auditor training. I have attended classroom training and found them extremely beneficial and enjoyable. Trainers are very understanding and knowledgeable.

Daniel Johnson
Washington, USA

I appeared for ISO 45001 auditor training course. Highlight of this course is good audio visual presentation, study material to download as well as exams to review my knowledge.

Charles Wilson
Abu Dhabi, UAE

Congratulations to Punyam Academy team for providing best knowledge sharing platform online. Achieved ISO 9001 internal auditor certificate, looking forward to enrol next auditor course very soon.

Karen Smith
California, USA

The course more economical compared to classroom training and flexible timings make it more recommendable. Looking forward for more complex courses like PMP, IRCA certified courses etc.

Ajit Patel
Altrafine Gums

I am highly satisfied with your course on food safety management system. Now I am fully aware about FoSTaC requirements and appreciate efforsts of Punyam Academy throughout the training session.

Dr. Bharat Agrawal
Analytical Development Laboratory Torrent Research Center

The training materials given by Punyam Academy experts proved to be very useful in managing our own requirements. We appreciate trainer's knowledge and efforts in delivering good sessions. All the best for upcoming training programs.

Alpesh Patel
Meghmani Industries Limited

I am happy with the certified ISO/IEC 17025:2017 auditor training course at Punyam Academy. Now I am fully aware about ISO/IEC 17025:2017 transition auditing and quality management requirements for testing laboratory.

Shreeyansh Kumar
ISRO

Thank you Punyam Academy for providing me world class learning at affordable cost. Trainer has very good knowledge about subject. Training environment & facility at training center is exceptional.

Dattatray Sawarbandhe
CEO, Bombaywalla Foods

A great step has been taken by organizing Food Safety Training and Certification (FoSTaC). This knowledge sharing will only bring all the business motive together of common standard, quality and good healthy surrounding. My India is growing - Keep it up Punyam Academy.

Subhashchandra Pathak
Terapanth Foods Limited

Attending FoSTaC training course for food safety management system is awasome experience. Now I am fully aware about food and quality management requirements in food manufacturing organization.

Sachin Patel
Mazda Limited

Attending classroom training at Punyam Academy was a wonderful experience. I got the opportunity to learn FSSAI requirements as FoSTaC training from experienced instructors.

Sajan Peter
Saudi Arabia

I have purchased and successfully completed ISO 9001:2015 certified internal auditor training course. It is Very professional and helpful training program customised to achieve maximum customer satisfaction.

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