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HomePosts tagged 'FDA clearance'	FDA clearance	Applied Statistics for FDA Process Validation
April 12, 2017 GlobalCompliancePanel-Training
Applied statistics, fda, FDA 21 CFR Part 11 Compliance, FDA Compliance, Health & Environment Management System, LifeScience, New FDA FSMA Rules, Non-Statistician, Pharmaceutical Laboratories, regulatory industry, risk management, Safety Management, seminar, Uncategorized	fda, FDA 21 CFR Part 11, FDA approval, FDA clearance, fda compliance, FDA Guidance, fda regulation, fda regulations, safety and health management, seminar, Software Validation, statistical process control, Statistics	The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.
III. Continued Process Verification.
Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.
In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900806SEMINAR?linkedin-SEO. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
o Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.
A Tour of the FDA 2017
April 5, 2017 GlobalCompliancePanel-Training
fda, FDA 21 CFR Part 11 Compliance, FDA Compliance, New FDA FSMA Rules, Uncategorized	fda, FDA approval, FDA clearance, fda compliance, FDA Device History File, FDA Guidance, FDA inspectional observation, fda regulation, fda regulations, fda standards, FDA Warning Letter	A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.
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The FDA’s requirements for Drug Applications and Submissions
April 4, 2017 GlobalCompliancePanel-Training
DRUGS, FDA 21 CFR Part 11 Compliance, FDA Compliance, New FDA FSMA Rules, Uncategorized	FDA 21 CFR Part 11, FDA clearance, fda compliance, fda regulation, FDA Warning Letter, HEALTHCARE	The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions.
The NDA is one the two mechanisms through which the FDA accepts drug applications and submissions. This application is available with the FDA. Any sponsor of a clinical study, be it an organization or an individual, can apply for the NDA and can submit the same, when it is convinced that it has sufficient evidence that its study meets the FDA’ requirements for marketing approval.
The way to go about filing for an NDA as part of drug applications and submissions is this:
The ANDA process
The ANDA is the other method of drug applications and submissions to the FDA. Being the counterpart of the NDA; the ANDA is the application a company makes for getting a generic drug approved by the FDA for marketing. The ANDA also has to contain the same data as contained in the NDA drug applications and submissions, but is not required to be accompanied by the data of the clinical research. It is for this reason that they are called by their name.
In place of the clinical research data, the ANDA format of drug applications and submissions has to contain evidence that the product has the ability to perform the same functions of the original drug. This is called the drug’s bioequivalent value. Like in the case of the NDA, the ANDA too is allocated a reference number as part of its drug applications and submissions.
Common factors taken into consideration
In either of these methods, the primary considerations for the FDA include the following:
The safety and effectiveness of the drug
Its ability to meet its intended use
Its ability of its benefits to outweigh its risks
The appropriateness of the drug’s planned labeling and its contents
The ability of the methods used in the manufacturing of the drug to meet Good Manufacturing Practice (GMP)
The capacity of the drug to have to controls in place for maintaining its quality, purity, strength and identity
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March 14, 2017March 14, 2017 GlobalCompliancePanel-Training
fda, FDA 21 CFR Part 11 Compliance, FDA Compliance, New FDA FSMA Rules, Uncategorized	fda, FDA approval, FDA clearance, fda compliance, FDA inspections, fda regulation, FDA requirement, FDA Training, New FDA FSMA Rules	The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety Modernization Act (FSMA), under congressional instructions.
DME’s help improve the quality of the patient’s life at home
July 24, 2012July 24, 2012 GlobalCompliancePanel-Training
HEALTHCARE, MEDICAL DEVICE, Medical Devices Training, PHARMA	DurableMedical Equipment, FDA clearance, medical device, Premarket Approval	Description: The patient must be incapable of performing routine activities without the DME
What is a DurableMedical Equipment?
Any medical equipment used in the home in order to help in a better quality of living can be called as durable medical equipment (DME). This includes iron lungs, oxygen tents,power scooters, Nebulizers, catheters, hospital beds, wheelchairs, walkers, and portable oxygen equipment.
Characteristic Features of a Durable Medical Equipment
An equipment is called as a DME, if
It is primarily used for medical purposes and is meant to be used for medical purposes
If it can be subject to repeated use
In the absence of a medical condition, this equipment is of no use to the person
It is designed to be used in and around the home
Certain insurances cover prosthetics, orthotics and certain other supplies, which are collectively denoted as POS, under durable medical equipment. These are devices that can replace missing body part, and support or correct any bodily malfunction.
Equipmentthat are Not Durable Medical Type
Items that are use-and-throw are not durable medical equipment; some examples are surgical face masks, incontinence pads and leggings.
Items that are not appropriate to be used at home, such as paraffin bath units and oscillating beds.
Items that need to be used under medical supervision or under medical institutional settings
Items that are not intended to be used in the home but are primarily used outside the home.
Items used for convenience rather than medical need. Some examples are stairway elevators, bathtub and toilet seats.
Qualifying for a DME
Any person can purchase durable medical equipment on a prescription from his treating physician. For one to qualify for a DME reimbursed by his or her insurance the following criteria need to be met:
The equipment must be a medical need for a normal living.
It must meet the definition of durable medical equipment.
The physician must justify that the DME is a requirement to safety and effectively treat the patient.
The patient must be incapable of performing routine activities without the DME
The physician must prove that the absence of the DME significantly hampers the patient’s normal living.
The patient must be able to operate, or use the equipment without any assistance.
The equipment must be safe enough to be used in a home environment.
Some insurance companies cover certain disposable items as a part of durable medical equipment reimbursement if they can significantly lower the risks associated with the medical condition and or if they are important preventive care measures. Some examples are nondurable items such as lancets and test strips used for glucose testing in diabetics.