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Home » 21 CFR Part 820 Subpart K: Labeling and Packaging Control

21 CFR Part 820 Subpart K: Labeling and Packaging Control (ELM-311)

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 K: Labeling and Packaging Control
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 ReviewsLabeling may seem like a relatively simple topic, bit it is a very complicated topic with regards to medical devices. Before we go too far, let's start with the basic definition of "label". The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
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 K: Labeling and Packaging Control 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

Labeling and Packaging Control - Subpart K
Course Introduction
Learning Objectives
Labeling and Packaging Control - Sec 820.120/130 - Part 1
Labeling and Packaging Control - Sec 820.120/130 - Part 2
Label Integrity
Stability Studies - Various Time Points
Stability Studies - Accelerated Studies
Stability Studies - Closed and Open Container
Transportation Studies - Procedure
Transportation Studies - Simplified
Labeling Operations - Static Vs Dynamic
Labeling Operations - Handled Differently

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of 31 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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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