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Medical Devices : ISO 13485 Internal Auditor

Rated 5 out of 5

12

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

ISO 13485 sets the quality management requirements that medical device organizations must meet to satisfy regulators and protect patients. Internal audits are how organizations verify they are actually meeting those requirements. This course provides a practical introduction to planning, conducting, and reporting internal audits in line with ISO 13485:2016 and ISO 19011:2018 guidelines.

What you’ll learn?

Principles and requirements of ISO 13485:2016
How to plan, conduct, and report internal audits
Apply ISO 19011 auditing guidelines in medical device environments
Identify nonconformities and support corrective and preventive actions

Who should enroll?

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum:

Introduction
Overview of ISO 13485 : 2016 Standard Internal
Lesson 1: Quality Management System</strong
Lesson 2: Management Responsibility
Lesson 3: Resource Management
Lesson 4: Product Realization
Lesson 5: Measurement, Analysis, and Improvement
Glossary
Evaluation

Author:

Dr. Ciaran McEnister

Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

Rated 5 out of 5

12

The 'ISO 13485:2016 Internal Auditor' course was pivotal in sharpening my audit skills. As a Regulatory Affairs Specialist, I found the content directly applicable to my work, enhancing both my confidence and efficiency. The certification has added valuable credibility to my professional profile

$95

Participant(s):

Buy now

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This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.