Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~30 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: 21 CFR Part 820 Subpart B - Quality System Requirements
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Administration (FDA) guidance documents, as well as other standards in order to provide clarification on how 21 CFR 820 is interpreted and enforced. In the second part of this program (this course) we will cover management requirements, quality audits and personnel.
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.
21 CFR Part 820 Subpart B - Quality System Requirements course is included in the following Professional Certification Programs:
ISO, ICH and the FDA
Definition of a medical device
Class I, II and III
History of 21 CFR Part 820
21 CFR 820 Timeline
1906 - The Jungle
1937 - Massengil Company
1957 - Thalidomide
1971 - Dalcon Corporation
1990 - FDA device recall report
A regulatory evolution
Quality System Requirements - Subpart B
Management responsibility - Sec 820.20(a) Part 1
Management responsibility - Sec 820.20(a) Part 2
Organizational structure - Sec 820.20(b)
Separation between quality and production - Sec 820.20(b)(1)
Organizational chart - Sec 820.20(b)(2)
Management representative - Sec 820.20(b)(3)
Management review - Sec 820.20(b)(c)
Quality planning - Sec 820.20(d)
Quality audits - - Sec 820.22
Internal quality audits
First, second and third party audits
Audit example (Cont'd)
Personnel - Sec 820.25
Training - Sec 820.25(b)
Personnel notified of defects - Sec 820.25(b)(1)(2)
Personnel Vs employee file
This training program has been developed to train employees with Intermediate Knowledge of 22 CFR Part 820 (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.