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

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

Certification TrainingProgram/Course ID: ELM-807
Enrollment Period: 3 months.
Allocated Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $199.00

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Training Program: ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsAs one of the measurements of the effectiveness of the quality management system the organization must have documented processes to gather and monitor information to show that the customer requirements have been met.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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).

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A) is Included in the Following Professional Certification Program(s):



 Professional Certification Program: 
ISO 13485:2016 Professional Certification Program
Course ID: ISOPCRT
Price: $1295.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

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Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
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  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
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  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
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