Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $199.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: ISO 13485:2016 - Chapter 4: The Quality Management System (QMS)
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. The learning objectives for this course are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. Also, to provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards. In module 4 we will explain documentation requirements, the quality manual, the medical device file, control of documents, control of records and good documentation practices.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
ISO 13485:2016 - Chapter 4: The Quality Management System (QMS) course is included in the following Professional Certification Programs:
CFR, ICH and The FDA
Challenges facing the medical device industry
Single user license
The Quality Management System (QMS)
Documentation requirements - foundation
Documentation requirements - supporting documents
The quality manual
Structured to mirror ISO 13485
The medical device file
The medical device file index
Control of documents
Advantage of numbering documents
Revision history - part 1
Revision history - part 2
Release and effective date
Revision history - part 3
Obsolescence of documents
Approved suppler / vendor list
Control of records
Good documentation practices
Signatures and initials - part 1
Signatures and initials - part 2
Date and time format - part 1
Date and time format - part 2
Blue or black pen
How to correct documents
Rounding of numbers
Number of pages
This training program has been developed to train employees with Intermediate Knowledge of ISO 13485:2016 (Medical Devices).
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.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- 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.
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.