Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900774SEMINAR?linkedin-SEO

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?wordpress-SEO .  This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Standard Operating Procedures are crucial documents in the regulatory industry

 

Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, set regulatory requirements for the particular industry, and the relevant State or local laws provincial laws are explained. Many a time, a Standard Operating Procedure can be just a description of the organization’s own mode of doing things related to its business.

So, this description leads to the fact that since a Standard Operating Procedure is a detailed description of how things are to be done by an organization; any such document in the medical devices industry contains a list of step-by-step procedures the manufacturing organization lays down for producing its products. In a larger sense, an SOP is a complete depiction of all the practices followed by a business that has to meet the required quality and regulatory standards.

Get trained on how to write Standard Operating Procedures effectively

Given the acute importance of Standard Operating Procedures; it is important for regulatory professionals to get a clear idea of how to approach them by getting a thorough understanding of this concept. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is being organized to give a thorough understanding of how to write Standard Operating Procedures effectively for the medical devices industry.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, who has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and who manages activities within the global regulatory and compliance space; will be the Director of this seminar.  To gain a clear understanding of the topic of Standard Operating Procedures for the medical devices industry, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900760SEMINAR?wordpress_seo . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear clarification of all the major issues and aspects relating to Standard Operating Procedures will be one of the core purposes of this seminar. Writing a Standard Operating Procedure should be simple, or at least, that is what it appears in theory. In reality though, writing Standard Operating Procedures or procedural documents is quite challenging in the regulated industries, because the Standard Operating Procedures have to take a whole host of procedures, processes, practices and factors into consideration.

The FDA requires “proof of establish” for writing Standard Operating Procedures

In order to make this easier, the Director of this seminar will make the participants of this seminar understand the cornerstone of writing Standard Operating Procedures, which for the medical devices industry, is what the FDA calls “proof of establish”. This is the foundation of FDA regulations and guidance documents for this industry, and consists of the entire array of activities pertaining to the practice of how to define, document (in writing or electronically) and implement that which is written.

Once this rationale for the Standard Operating Procedures is clear, the step-by-step set of instructions needed for performing a particular job or task in the regulated industries flows more easily.  This is the teaching David will instill at this seminar on Standard Operating Procedures.

Writing Standard Operating Procedures is not the end; implementing what is written is

This said, writing the set of Standard Operating Procedures is by no means the end of the work for regulatory professionals. Implementing that which has been created and are in the process of being created is much more vital. David will offer understanding of this aspect by presenting topics associated with how to write, format, execute, manage and globally harmonize Standard Operating Procedures. This is going to be explained keeping in mind the fact that SOP’s are the most popular documents audited by FDA and other Agencies, as well as by auditors and customers.

Standard Operating Procedures and GDP

This seminar on Standard Operating Procedures will also give a detailed understanding of Good Documentation Practices required by companies to ensure GMP compliance and the role played by Standard Operating Procedures in helping achieve the required level of compliance and quality.

This seminar will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The Director will show recent enforcement actions for Standard Operating Procedures related violations, most of which are documentation related. He will also emphasize the fact that Standard Operating Procedures work best when they are designed to achieve specific results, and will teach participants the ways by which to determine what business goals will be achieved through better management with Standard Operating Procedures and how those goals will be measured.

https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical, and well-defined. Although all these processes can be put in place for only one function; it makes better business and economic sense to have a management system that performs and carries out its objectives across a spectrum of functions and activities.

Organizations should ideally build a comprehensive and thorough management system that should be a set of standards and practices that addresses the organization’s safety, health and environment management aspects. A major advantage having such a system brings is that it makes the entire process efficient, consistent, cost effective and timely.

Creating a fulcrum for health and environment management systems

An effective and proven way of making management systems work effectively is for corporations to use the business asset to set and create inputs for the various standards around the functions. The standards and practices that are put in place in such a manner become the basis and edifice on which decisions relative to resources and dollars spent within the Safety, Health & Environment (SH&E) scope of business are made. In other words, a management system works best and most effectively when it becomes a pivot around which a host of functions can be performed.

Safety, health and environment are the core issues of a sound management system. If organizations have to build an SH&E system that is designed along the lines described above; they need to have the ability to properly assess their requirements first. They need to also have the foresight to anticipate the changes that these functions will undergo in the future, and should build a management system that has the robustness, flexibility and resilience to accommodate and ingest these changes. The financial consequences of building a management system that fails to take these factors into consideration are huge.

A management system that takes SH&E into consideration can achieve a lot

This process accomplishes the following:

o  Identifies the things that need to be managed within the function

o  Constructs a process, tool, or mechanism that best manages each of those things identified. They are usually a set of standards, practices and programs that are built specifically for a particular function

o  Builds the standard, practice or program so that it can be adjusted according to results

o  Builds a measuring metric, benchmark or scorecard with both lagging and leading indicators

o  Builds the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

Trainings for inculcating the mindset for building a strong management system

The principles to adapt and the thinking needed to cultivate the outlook for building such a management system will be the core part of a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

James J. Thatcher, President and Owner, Global Safety Solutions LLC., who is listed as an expert witness for operational as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry; will be the Director at this learning session. Please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900842SEMINAR?wordpress_SEO    to register for this highly valuable learning session.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

In-depth exploration of SH&E management systems

This seminar will make an in-depth exploration of management systems in the health and environmental areas. James will offer a detailed understanding of SH&E, plus Training and Security (TS), which are the functions around which standards and practices are built. He will describe the 16 functions that cover the SHE & TS world in detail, which will help participants understand ways by which to build a standard and practice around all these 16 functions.

The 16 functions that will have a standard and practice specific to the function are:

o  Hazard identification & control

o  Occupational health & industrial hygiene

o  Incident management

o  Emergency preparedness

o  Environmental

o  Regulatory compliance

o  Reporting performance

o  Managing risk

o  Managing safety

o  Management security

o  Verification & audits

o  Document & record management

o  Contractor & service provider management

o  Competency management (training)

o  Commitment, communication and implementation

o  Managing change

The Director of this seminar will also explain the role of supporting documents, associated programs, procedures or Standard Operating Procedures (SOP) that are a part of the particular function being managed, to enable clear understanding of the topics.

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need to know exactly what to do in order to pass a HIPAA audit. This is all the more important and necessary considering that the federal budget has plans of raising the budget for the OCR in 2017 by about 10% over 2016, reflecting just how serious the OCR is about HIPAA audits.

When one considers that Phase 2 of HIPAA requires compliance with something like 180 areas and allows just 10 days for response; it goes without saying that HIPAA survival is a high priority for Covered Entities and their Business Associates. Moreover, the OCR’s audit protocol clearly states that those entities that are being audited have to furnish the exact documents required and not offer broad references to policy documents.

Being even slightly lax in being prepared for Phase 2 HIPAA audits can lead to difficulties at the audit. So, HIPAA survival entails having to be one’s toes all the time and having all the edges covered and leaving nothing to chance. HIPAA survival is about putting a process in place and overseeing and implementing it with utmost diligence and attentiveness all the time.

Covered Entities and Business Associates are the target of HIPAA audits

So, where do all these place Covered Entities and Business Associates that are the target of HIPAA audits? There is simply no room for complacence. They have to be absolutely on their guard when facing HIPAA audits. HIPAA survival has to be cultivated as a means for this. The more they hard-wire the art of HIPAA survival into their practice, the better.

The ways by which Covered Entities and Business Associates deal with HIPAA survival is the subject of a two-day seminar that GlobalCompliancePanel, a highly popular provider of professional trainings for the areas of regulatory compliance, will be organizing. To enroll for this highly useful and important session on HIPAA survival, jus log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900780SEMINAR?HIPAA-survival-Chicago-IL.

At this seminar, Brian L Tuttle, a senior Compliance Consultant & IT Manager at InGauge Healthcare Solutions, will educate regulatory compliance professionals about how practice managers need to prepare for HIPAA audits. This seminar will address major changes under the Omnibus Rule and any other applicable updates for 2017. Brian will also cover other related, critical areas such as:

o  Texting

o  Email

o  Encryption

o  Medical messaging

o  Voice data, and

o  Risk factors as they relate to IT.

Brian will dispel many of the myths covering this convoluted law. He will discuss the do’s and don’ts of HIPAA survival, and will also cover the critical area of the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.

During the course of this seminar, Brian will cover the following areas:

o  History of HIPAA

o  HITECH

o  HIPAA Omnibus Rule

o  How to perform a HIPAA Security Risk Assessment

o  What is involved in a Federal audit and how is it conducted

o  Risk factors for a federal audit

o  EHR and HIPAA

o  Business Continuity/Disaster Recovery Planning

o  Business Associates and HIPAA

o  In depth discussions on IT down to the nuts and bolts

o  BYOD

o  Risk factors that can cause an audit (low hanging fruit)

o  New rules which grant states ability to sue citing HIPAA on behalf of a patient

o  New funding measures

https://www.onr.com/blog/hipaa-audits-increase-2016-2017/

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions.

Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to initiate medical device reporting (MDR) and recalls.

What is medical device reporting?

Procedures for medical device reporting are governed by 21 CFR 803, which has details regarding how a medical device company should go about its MDR.

Who have to make MDR?

The FDA deems it mandatory for these entities to report certain types of adverse events and product problems:

For the following entities, MDR is voluntary and is to be done when serious adverse events are detected in the medical devices they use:

  • Professionals
  • Patients
  • Caregivers, and
  • Consumers

These categories can also report issues relating to product quality, therapeutic errors and use errors.

What is a recall?

A recall can be either of these:

  • When a firm voluntarily removes or corrects an already marketed device that is found by the FDA to be in violation of its governing act on these devices, namely the Federal Food, Drug, and Cosmetic Act. Seizure of a medical device is an example of this kind of action.
  • A recall also happens when a firm voluntarily determines, after investigation, that a device is adulterated in some way. An example of this instance is misbranding, when a manufacturer discovers that the device is not fulfilling its intended use.

A recall is important for two reasons:

How does a medical device company report a recall?

Firms have to follow 21 CFR Part 806 when they have to reporting Medical Devices Recalls, as set out by The Center for Devices and Radiological Health. The Center makes it a requirement for a firm to report when the medical device is posing a risk to health. This has to be reported to the FDA District Office in which the firm is located.

Our webinars can help you gain more comprehensive knowledge of this topic and related ones. Click here (link) for details.

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HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself specifically with electronic Protected Health Information (ePHI). Since it particularly focuses on an element of the Privacy Rule; it is considered a subset of the HIPAA Privacy Rule.

The HIPAA Security Rule seeks to fortify individually identifiable health information with reasonably high levels of technical, administrative and physical safeguards so that these attributes are protected and unauthorized or inappropriate access, use, or disclosure prevented:

  • Confidentiality
  • Integrity, and
  • Availability.

To enable this, the HIPAA Security Rule codifies a few standards and best practices in information technology. In a general sense, the HIPAA Security Rule requires computer systems containing patient health implementation to implement these three safeguards:

  • Administrative,
  • Physical, and
  • Technical.

It has clear definitions of each component relating to its specifications. Some of the terms on which the HIPAA Security Rule is unambiguously clear are:

Challenges associated with implementing HIPAA Security Rule:

Despite the clarity of definitions of a few terms as stated above; the HIPAA security rule is considered complicated by practitioners and participants in the Rule. Although not a very painfully long document in that it runs into only eight pages; because of the high technical nature of its text, it is considered quite complex.

A major requirement that the HIPAA Security Rule imposes is a set of additional organizational requirements, apart from documenting processes that are in tune with the HIPAA Privacy Rule. This is easier said than done, especially for small time providers that have limited technical bandwidth and capabilities, for whom implementing the Privacy Rule itself can be challenging. The solution is to make Health information technology (HIT) resources available for this kind of providers.

Further, this Rule has some ambiguities. For instance, its fundamental requirement is implementation of “necessary safeguards”. There is no unanimity about what this means.

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