FDA / GMP

__________________________________

Accelerated Group is one of the world's leading consulting companies and provides training, consulting certification, automation, internal audits, acquisition audits, supplier audits, FDA Audits and CGMP Audits for worldwide standards.

__________________________________

Consulting, Training, Certification, Supplier Management, and Auditing Services:

We offer written guaranteed consulting, training, certification, and auditing services for worldwide standards for the FDA.

__________________________________

FDA / GMP Online Training by Standard:

8 D Problem Solving Methodology, Corrective Action, and Good Business Practices

CE Marking (90/385) for Active Implantable Medical Devices- Essential Requirements Only

CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing

CE Marking (93/42 ECC) for medical devices- Essential Requirements only

CE Marking (93/42 ECC) for medical devices- Implementation and Auditing

CE Marking IVD 98-79 EEC Implementation and Auditing

CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only

Dietary Supplements: Overview Based on FDA Guidance 2002

Environmental, Health and Safety Training for meeting DOT, ISO 14001, OSHA, OSHA 18001,.........

FDA-GMP Good Laboratory Practice for nonclinical (21 CFR part58) Implementation and Auditing.

FDA/CGMP Medical Devices Executive Overview & Management Review for meeting FDA requirements

FDA/CGMP Blood - Implementation & Audit/Auditor

FDA/CGMP Drug (Pharmaceutical) - Implementation and Audit/Auditor (21CFR210-211)

FDA/CGMP Food - Implementation & Audit/Auditor

FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation

FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation in Chinese

FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation in Spanish

FDA/CGMP Medical Devices Executive Overview & Management Review for meeting FDA requirements in Spanish

FDA/CGMP Medical Devices Executive Overview & Management Review for meeting FDA requirements Chinese

FDA/CGMP Medical Devices Introduction & Employee Overview

FDA/CGMP Medical Devices Introduction & Employee Overview in Chinese

FDA/CGMP Medical Devices Introduction & Employee Overview in Spanish

FMEA, Risk Analysis for Medical Devices

Hazard Communication Training for meeting DOT, OSHA, OSHA 18001, ISO 14001, HACCP..

ISO 14971 Risk Management Implementation & Auditing/Auditor meeting FDA /ISO13485/CE Marking

__________________________________

What is FDA / GMP?

 

The Good Manufacturing Practices (GMP) regulation, promulgated under section 520 of the Food, Drug and Cosmetic Act, requires that domestic or foreign manufacturers of medical devices intend for commercial distribution in the United States have a quality assurance (QA) program. The regulation requires that various specifications and controls be established for devices and that finished devices meet these specifications. Thus, the GMP regulation helps assure that medical devices are safe and effective for the intended use. The Food and Drug Administration (FDA) monitor device compliance with the QA program requirements in the regulation.
 

Manufactures and importers of medical devices must also comply with the Medical Device Reporting (MDR) regulation, 21 CFR Part 803, which requires that serious complaints be reported to the FDA.
 

The GMP regulations apply to the manufacture of finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect.
 

Certain components such as blood tubing and major diagnostic x-ray components may be considered to be finished devices because they are accessories to finished devices. The manufacturer of such components or accessories is subject to the GMP regulation when the accessory device is labeled and sold separately from the primary device for a health-related purpose to a hospital, physician, or other user.
 

The designation of a device as a "custom" device does not confer a GMP exemption.
 

Contract manufacturers and specification developers must comply with the sections of the GMP regulation that apply to the functions they perform. Contract test laboratories are considered an extension of a manufacturer's quality assurance program and presently are not routinely scheduled for GMP inspections.
 

Internal test laboratories, however, that are part of a corporate firm that provides services to individual corporation factories, are inspected as part of the FDA GMP inspection of the member factories.

 

Source: Device Good Manufacturing Practices Manual fourth Edition

 

__________________________________

 

Regulatory Models (Global Harmonization Task Force (GHTF) members)
	US	Australia	Japan	EU	Canada
Regulatory Body	Food & Drug Administration (FDA)	Therapeutic Goods Administration (TGA)	Ministry of Heath and Welfare (MHW)	Competent Authority (CA)  ( 15 states )	Health Canada (HC)
QS standard	QSR: 21    CFR 820	ISO 13485/8 or EN 46001/2	QS standard 1128	EN 46001/2/3	ISO 13485/8
Quality Systems auditor	FDA	TGA	MHW	Notified Body (NB) (3rd party)	Registrar (3rd party) (CMDCAS)
Pre-market reviewer	FDA	TGA	MHW	(NB) (3rd party)	HC
Post-market compliance & enforcement	FDA	TGA	MHW	(NB) (3rd party) + CA	HC (6 Regions)