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A Tour of the FDA | globalcompliancepaneltraining
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January 16, 2018 January 16, 2018 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, MEDICAL DEVICE, medical device reporting and recalls, medical devices, Medical Devices Training, Medical Professionals, New FDA FSMA Rules, Uncategorized	Complaint Handling Procedures and Guidelines, education, Effective Complaint Handling Guidelines, FDA Complaint Handling Regulations, FDA Guidance on Complaint Handling, HEALTHCARE, Medical, Medical Device Reporting, Project Management, techniques, training
Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality.
The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”.
FDA’s complaint handling guidelines are critical for ensuring that an organization maintains safety with regard to the medical devices they manufacture. Errors in medical devices can result in complaints, and improper handling of complaints can lead to problems for the patient, ranging from injury to fatality.
It is to prevent these problems that the FDA has issued complaint handling guidelines. FDA’s thinking is based on the reasoning that a complaint may be an indicator of serious safety, but implementing effective complaint handling guidelines can greatly mollify the gravity of the issue. It is also the first step to initiating new product development, which in turn has the potential to greatly reduce risks associated with noncompliance.
Provisions relating to effective complaint handling provisions are contained in FDA 21 CFR Part 820 and GxP regulations.
Firstly, these complaint handling guidelines require medical device manufacturers to maintain complaint files. Manufacturers have to make this the first step towards establishing a sustainable complaint management system.
Secondly, Section 198 of Part 820 warrants the following:
Thirdly, FDA 21 CFR Part 820 requires the manufacturer to establish and maintain procedures for the receipt, review, and evaluation of complaints.
What should records of investigation contain?
Records of investigation should contain the following:
Identifiers related to the device and reported event
If Medical Device Reporting is made, it should investigate the following:
Whether there were any specifications the device failed to meet
Whether it was for treatment or for diagnosis that the device was being used
In what way the device was related to the reported event, if applicable
January 8, 2018 January 8, 2018 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized	and Cosmetic Act, Aspects of Regulatory History, best practices, design, Drug, education, Ethical and Regulatory Aspects of Clinical Research, FDA Regulatory Requirements, Food, HEALTHCARE, HIPAA, leadership, management, Medical, Nutrition Labeling and Education Act, Project Management, QA, Statistics, techniques, training, US regulatory
January 5, 2018 January 5, 2018 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized	best practices, design, e-learning, education, FDA Good Documentation Practices Regulations, FDA Warning Letter, Good Documentation Practice Guideline, good documentation practices procedure, HEALTHCARE, HIPAA, management, Manufacturing, Medical, Project Management, Requirements for Good Documentation Practice, Statistics, techniques, training
Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.
Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.
What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.
This is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.
Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:
What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:
The EMA’s requirements
The EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to
All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down
Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.
And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.
FDA Warning Letters – an understanding
January 3, 2018 January 3, 2018 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized	Compliance and Regulatory Information, Compliance Best Practices, fda regulations, fda regulatory compliance, FDA Regulatory Compliance Practices, Regulatory and FDA compliance, regulatory compliance, US FDA Regulatory Requirements
As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.
The FDA issues a Warning Letter to a company when it determines, following its inspection of a facility from an industry that it regulates, that the facility is violating some or other terms of the provisions of the FDA Act. The FDA Act is a legislation that gives the FDA the authority to carry out its inspections.
The issuance of an FDA Warning Letter is an indication that the facility is practicing some degree of nonconformity. A Warning Letter is among the FDA’s strongest tools of ensuring voluntary compliance from organizations with the provisions of the FDA Act.
The FDA publishes on its website any deviances of regulatory significance that it discovers from a facility during its investigations. In its viewpoint, a deviation of regulatory significance is one that leads to enforcement actions if the facility fails to carry out corrective action of whatever violations the FDA has documented.
Types of Warning Letters from the FDATo enable the public and concerned parties to view the Warning Letters it issues from time to time; the FDA has classified these on its website in the following manner:
A General Warning Letter is one that is issued to a company in whose activities the FDA notes significant variations from the principles laid out in the FDA Act. The Warning Letter carries a description of the variation or violation that the manufacturer has been practicing, along with a description of what actions needs to be taken to correct it.
Tobacco Retailer Warning Letters are those that are issued to manufacturers of products made out tobacco, such as cigarettes, smokeless cigarettes and related ones, who are found to be violating the provisions of the FDA’s Tobacco Control Act and with provisions of Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).
Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies) are those Warning Letters that the FDA website sorts out by month and consist only of Division of Drug Marketing and Communications and Drug Warning Letters. This kind of Warning Letter is issued to sellers of prescription drugs online when they are found to violate terms set out by the FDA.
Warning Letter closeout program
When the FDA issues a Warning Letter to a facility that comes under the various classifications; it follows up with it from time to time to ensure that the suggestions it advises are carried out. When the facility has carried out the necessary corrective actions; the FDA issues the Warning Letter Closeout, which closes the matter associated with the Warning Letter until the next FDA inspection.
Methods of issuing Warning LettersIt is only when it discovers violations that the FDA issues Warning Letters. It is through inspections that it discovers violations, from which Warning Letters follow. However, the FDA can also issue Warning Letters to facilities about which its receives complaints of wrongdoing from state personnel.
An FDA Warning Letter is not an enforcement action
In the perspective of the FDA; a Warning Letter is of an informal and advisory nature. An FDA Warning Letter is a description of the violation observed at a facility; but this in itself does not make the FDA take enforcement action. Rather, through a Warning Letter, the FDA advices the organization on what steps it has to take in order to rectify and correct the reasons for which the Warning Letter was issued. An FDA Warning Letter offers the organization enough opportunity to take corrective action that is of a voluntary and appropriate.
December 14, 2017 December 14, 2017 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized	FDA IMPORT and EXPORT COMPLIANCE, FDA Import for Export Requirements, FDA Import Form, FDA Import Program, Importing FDA Regulated Products into US, Tougher import rules for FDA, US FDA Regulations
Import rules are very rigid and strict in the US, because products of any type and variety can enter the US. The US being the world’s largest consumer economy; manufacturers and marketers from around the world vie for a chunk of this market. The FDA, being the agency that regulates a myriad of products, has rules for imports to the US, which have been toughened of late.
The total number of lines imported to the US more than doubled from 2006, when it was at 15 million lines, to over 35 million in 2016 (The FDA considers a distinct product within a shipment as a line). The FDA’s vigil on products that enter the US and by consumed by Americans is quite understandable: in the fiscal year 2016; among all the imported lines that entered the US; about half consisted of medical devices, and about a third, of foods, both of which are very crucial to human health.
Rules relating to import of drugs
Another core component of US imports is drugs, which is also extremely crucial to humans. The FDA has very stringent rules for the import of drugs. it does not consider the regulatory approval of any other regulatory agency as acceptable in the US. It considers only regulation of drugs by it as the criterion for accepting imports of drug products. In some cases, however, it relaxes these rules, subject to the condition that the stock of the drug may only be shipped for three months of treatment at a time:
The FDA has now collaborated with the Customs and Border Patrol Service (CBP), putting even tougher import rules in place. The FDA has not only got tougher in its import rules; it has become even more sophisticated in tracking and detecting importers who violate its rules. New rules require importers to submit many kinds of information and to adhere to set procedures laid out by the government in this regard.
Strict when it comes to penal actions, tooWith the FDA tightening its grip on imports; a foreign manufacturer whose products come under an FDA Import Alert is up against a hill when it comes to importing its products into the U.S. The FDA and the CBP can delay, detain or refuse its shipment or detain a shipment of a company that violates these rules.
The consequences of having a shipment detained
The consequences of having a shipment detained by the FDA can bring its adverse consequences:
Tougher FDA import rules arm the FDA with the power to begin a potentially long drawn out and expensive legal process
It will have very little time to respond to queries from the FDA or the CBP. Not responding in time invites further penalties
A fine that is three times the value of the goods contained in the shipment may be imposed
At times, their product can be seized ty the government and destroyed
If a violating importer receives a release but cannot locate the product that has been sold, it should bring the products back to the port of entry and face adverse legal steps
A few remedial measures
The only real antidote to avert profound consequences of the FDA’s tougher import rules is to be aware of the rules in their entirety. A company that has a sound understanding of the legal and prior notice information requirements has a safe passage compared to a company that doesn’t.
December 12, 2017 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized	best practices, design, Differences between clinical trials and post marketing, education, finance, HEALTHCARE, management, Medical, Post-marketing monitoring, Pre-marketing clinical trials, Premarketing Clinical Evaluation, Premarketing Clinical Trial Safety, Premarketing Risk Assessment, Project Management, Running, techniques, training
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December 11, 2017 GlobalCompliancePanel-Training A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized	Acceptance of Foreign Clinical Data, best practices, design, education, fda acceptance of foreign clinical trial data, fda guidance acceptance of foreign clinical studies, Foreign Clinical Studies, Foreign Clinical Studies for US Approval, foreign clinical studies requirements, HEALTHCARE, Medical, medicine, Project Management, Running, techniques, training
The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products
that are permitted under this system of foreign clinical studies include:
A human drug
A biological drug
The guidelines for foreign clinical studies requirements
The guidelines under which the FDA accepts medical products for approval when they are the result of foreign clinical studies are spelt out in various sections of 21 CFR.
Any foreign clinical study has to be meet requirements of 21 CFR Part 312or 21 CFR Part 812, which relate to studies conducted under an Investigational New Drug Application (NDA) or Investigational Device Exemption (IDE) respectively, just the same way in which American companies too have to
In case a foreign clinical study is not conducted under an IND; the FDA will still accept it, so long as it fulfills the ethical principles set out in the Declaration of Helsinki, or is in accordance with the laws of the respective country from which the study originates, based on whichever of these two offers stronger protection of the subjects of the study.
Highlights of the Helsinki Declaration
The World Medical Association adapted the Helsinki Declaration from the time it was passed in 1964. In 1975, given the popularity of the Declaration in guaranteeing humane protection of human subjects in a clinical study; the FDA adapted the principles of the Helsinki Declaration as the basis for accepting non-IND compliant drugs. This Declaration has been revised a few times, although the FDA is yet to include the latest of these, that of October 2000, into its regulations.