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FDA GMP: Medical Devices
Online Medical Device GMP Training-21CFR820 ($179.95)
Quality System Requirements -21CFR820

Overview

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act(See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices This regulation became effective on December 18, 1978, and was codified under part 820.

Course Objective

It has been specifically designed to meet the needs of people involved in current good manufacturing practices for medical devices. This course gives an in-depth understanding of the FDA and European cGMP requirements. It is helpful in understanding the legal requirements and regulatory expectations relating to CGMP, as well as the costs of non-compliance.

Course length

2-3 days (a few hours everyday) are required to complete the FDA-cGMP Medical Devices Training

Who should attend

This 7Step/CALISO online training course is for you if you:

  • You want to quickly and efficiently understand what the FDA's GMP for medical devices is about,
  • -you do NOT have time to allocate a full day /days to take a LIVE class on the cGMP Quality System Requirements (QSR),
  • -you want to train more of your staff on the GMP economically and without having to immobilize them in a class for a full day,
  • -you want to implement the GMP without using a consulting firm,

Course Benefits

The structure of the training is as follows:

  • PART 820--QUALITY SYSTEM REGULATION
  • Subpart A General Provisions
  • Subpart B Quality System Requirements
  • Subpart C Design Controls
  • Subpart D Document Controls
  • Subpart E Purchasing Controls
  • Subpart F Identification and Traceability
  • Subpart G Production and Process Controls
  • Subpart H Acceptance Activities
  • Subpart I Nonconforming Product
  • Subpart J Corrective and Preventive Action
  • Subpart K Labeling and Packaging Control
  • Subpart L Handling, Storage, Distribution, and Installation
  • Subpart M Records
  • Subpart N Servicing
  • Subpart O Statistical Technique

Authors: CALISO Corporation

 

Required Prerequisites

This is an internet-delivered course featuring graphical presentation screens with text-based instruction, videos, and on-going quizzes to reinforce learning and retention and gauge your understanding of a topic before you move forward. Convenient and portable, this course provides instruction without the expense of travel and time away from the workplace.

  • Internet Access
  • Browser cookies enabled
  • Recent browser such as Internet Explorer, Firefox, Chrome or Safari recommended

Award of Certificate

An online training certificate will be issued upon successful completion of the course and obtaining 70% or above on the final average of the ongoing quizzes. A final Exam is provided for trainees who have less that 70%.

With your registration, you will receive online access to the course until you complete it. The limit on course completion and access to your certificate is three years.

Quantity Discounts

Quantity discounts of 15% for 10 or more students registered. The discount is automatically calculated during registration by credit card.

Course Registration

Product Code

Status

List Price

 

FDA GMP: Medical Devices

In Stock

$179.95



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FAQs and Course Technical Assistance

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