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Friday, June 18, 2021
Home » 21 CFR Part 820 Subpart C - Design Controls

21 CFR Part 820 Subpart C - Design Controls (ELM-303)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: 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.

Biopharma Institute LogoTraining Program: 21 CFR Part 820 Subpart C - Design Controls
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 ReviewsIn 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 third part of this program (this course) we will cover design controls which are the foundation of product quality.
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 C - Design Controls course is included in the following Professional Certification Programs:



21 CFR Part 820 - Medical Device Professional Certification: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview
ISO, ICH and the FDA
Program organization
Program objectives
Definition of a medical device
Class I, II and III
Intended use

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

Design Controls - Subpart C
Course introduction
Introduction to design controls - Sec 820.30 (a)
Lifecycle approach
Marketing requirements
Feasibility
Documentation
Design and development planning - Sec 820.30 (b)
Goals and objectives
Task breakdown
Over optimistic schedule
Design input - Sec 820.30 (c)
User needs
Design input requirements
Unambiguous requirements
Complex products
Design output - Sec 820.30 (d)
Design review - Sec 820.30 (e)
Collection of reviewers
Systematic process
Design verification - Sec 820.30 (f)
Verification studies
Design validation - Sec 820.30 (g)
Validation plan
Clinical evaluations
Not a single document
Design transfer - Sec 820.30 (h)
Design changes - Sec 820.30 (i)
Change control process
Change levels
Design history file - Sec 820.30 (i)
Device master record
Design control conclusions

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of 23 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.

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