Student Login |


Friday, March 29, 2024
Home » ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A) Certification Training

 
Rated 4.7 / 5
(3 reviews)

Program/Course ID:ELM-807
Enrollment Period:12 months.
Average Learning Time:~45 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:0.1 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


.

Browse Our Catalog of 300+ Courses:

Catalog of Courses

Enroll into a Trial Course & Start Learning, Today:

Free Trial Courses

Outline:


Introduction
Overview
Course Introduction
Course Objectives
CFR, ICH and The FDA
Challenges Facing the Medical Device Industry
Single User License

Measurement Analysis & Improvement - Part A
General Introduction
ISO Systems
Monitoring and Measurement
Feedback - Identify, Define, Document & Implement
Feedback - Methods
Complaint Handling
Complaint Handling - Incident
Complaint Handling - Process
Complaint Handling - Difficult to Manage
Complaint Handling - A Common Mistake
Reporting to Regulatory Authorities
Reporting to Regulatory Authorities - Adverse Events
Reporting to Regulatory Authorities - USA Reporting Timelines
Reporting to Regulatory Authorities - EU Reporting Timelines
Reporting to Regulatory Authorities - Canada Reporting Timelines
Reporting to Regulatory Authorities - Reporting Formats - Part 1
Reporting to Regulatory Authorities - Reporting Formats - Part 2
Reporting to Regulatory Authorities - Conclusion
Internal Audit - Effectiveness of Quality System
Internal Audit - Two Different Approaches
Internal Audit - Auditors and Lead Auditors
Internal Audit - Table of Regulations
Internal Audit - Findings
Monitoring and Measuring for Processes - Introduction
Monitoring and Measuring for Processes - KPI's
Monitoring and Measuring for Processes - Corrective and Preventative Actions
Monitoring and Measuring for Processes - Other Factors
Monitoring and Measuring of Product - Introduction
Monitoring and Measuring of Product - Product Conformity
Monitoring and Measuring of Product - Tracking & Trending
Monitoring and Measuring of Product - Out of Control

Conclusion


Final Assessment


Certification

Objectives:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of ISO 13485:2016 (Medical Devices).

This Course is Included in the Following Professional Certification Program(s):



Professional Certification Program:

ISO 13485:2016 Professional Certification Program

Program ID: ISOPCRT
Price: $1295.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Use our Search Form to Find What You're Looking For:

  

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:


Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


For quotes or invoices please provide the course(s) and number of students.