Why IEC 60825 certification cannot be substituted for 21CFR1040

With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with 21 CFR 1040. Per Section 1010.2c, certification has to be based on a test that meets the requirements set out in this standard and has to be in accordance with Good Manufacturing Practices.

Since the CDRH does not approve form 3632 reports or the products being reported; it is incumbent upon the manufacturer, system integrator or importer to assume responsibility for certification. However, if the FDA detects gaps or deficiencies in the applicant’s quality control or testing program; the CDRH is empowered to take actions that are of a very harsh nature. It may:

o  Ask the manufacturer to halt introduction of the product into the US until the faults are corrected

o  Require the manufacturer to start a corrective action program for products that have already been released into the market

o  Impose fines of up to $300,000 for non-compliance with the requirements laid out in 21 CFR 1040.

What are the consequences of recalls?

When laser products that the FDA determines do not meet the regulatory requirements are recalled, it can have serious consequences for the business. It invites lawsuits from the user of such products. This can result in monetary losses that eat into the business’ profits. It can also damage the company’s reputation, which is something that is very difficult to overcome and compensate for.

So, the ideal course to follow for manufacturers of laser products is to be compliant in letter and spirit with the regulations laid out in 21 CFR 1040. The ways of achieving this and implementing best practices for compliance with FDA 21 CFR 1040 will be the teaching a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Tony Imm; a nationally recognized laser engineer with a background in medical device manufacturing, whose company, Laser Guardian LLC provides a wide range of laser safety and process support. To understand the ways by which to achieve compliance with FDA 21 CFR 1040 by implementing best practices; please register for this webinar by visiting Best Practices for Compliance with FDA 21CFR1040

Complete understanding of implementing best practices

Tony will give comprehensive understanding of the ways by which the test documentation system with the CDRH works. He will show how to generate form 3632 document, how to complete the form, what supporting data to attach with it and how, and then explain recommended methodologies to test and record the emission output and interlock performance of the laser systems. This session is extremely useful to those involved in working with laser products, such as Engineering Managers, Laser Engineers, Safety Manager, Safety Engineers, and personnel responsible for FDA communications.

Tony will cover the following areas at this webinar:

o  What is self-certification and when is it required

o  Methods for submitting a product report

o  Major sections of the product report

o  Why IEC 60825 certification cannot be substituted for 21CFR1040

o  What are best practices and why use them

o  Where to apply best practices and what they should encompass.

How does the FDA scrutinize Promotion?

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should include the following statement printed conspicuously for all products including vaccines:

“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.”

One of many requirements

This is just one of the many requirements from the FDA about promotion and advertising practices. Any individual or company holding an approved application for a drug will be panelized for making a false or misleading claim in a Direct to Consumer (DTC) advertisement about the pharmaceutical product.

Such an entity can be fined up to a quarter of a million dollars for the first such violation in any three-year period. This fine can go up to half a million dollars for each subsequent violation in any three-year period. Further, the FDAAA fixes different levels of penalties for biological products.

New requirements that reinforce existing ones

In addition, the FDA issued two Draft Guidance documents in January 2017. These concern communications made by device manufacturers about information that is contained in the labeling of these products. The nub of these Guidance Documents is that for FDA-regulated medical device companies to escape enforcement actions from the regulatory agency; labeling has to be consistent with the standards and expectations set out by the FDA. It lists out a number of factors the FDA takes into consideration to determine if the labeling meets the standards of consistency set out by it. These are some of them:

o  Indication

o  Patient Population

o  Limitations and Directions for Handling, Preparing, and/or Using the product

o  The recommended dosage or use regimen or route of administration

o  The potential for increasing harm

o  Safe and effective use.

The FDA has, in this communication also set out the factors that it does not consider as being in line with its idea of consistency in labeling and false claims:

o  Stage, severity, or manifestation of disease

o  Use alone versus in combination with other product(s)

o  Route of administration

o  Strength, dosage, or use regimen

o  Dosage form.

This makes the grasp and proper implementation of the FDAAA requirements absolutely essential if an organization in the FDA-regulated industries has to be free of enforcement actions from the FDA and subsequent penalties.

Learning session on how to get the dynamics of FDA scrutiny of promotion and advertising practices right

This is the important learning a webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Casper Uldriks, who through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He brings the experience of having specialized in the FDA’s medical device program as a field investigator, a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. To gain understanding and clarity on these areas of FDA scrutiny of promotion and advertising practices, enroll for this webinar by logging on to FDA Scrutinize Promotion and Advertising Practices

Anticipate the FDA’s viewpoint of consistency

Anticipating the way the FDA will view and interpret its advertising and the way it monitors this activity is critical for any company that makes a marketing launch. If it fails to do this right, it could land itself in trouble and invite expensive and reputation-damaging enforcement actions. Companies that come under FDA regulation need to have a perfect grasp of what they are doing with DTC advertising and should not leave anything to chance.

Companies have to keep up with the defined boundaries of DTC advertising and promotion if they have to avoid FDA scrutiny. If the FDA deems a DTC marketing campaign to be misbranding the product, it will not allow it to be marketed. This calls for more sophistication and novelty on the part of firms in their advertising methods and messages. Firms need to pay attention to all the components of their advertising in mass media, such as volume, images, the prominence and conspicuousness of information, the speed of the message, subliminal messaging and the core message.

Get all the factors right to avoid FDA enforcement

This calls for a proper understanding of what each component of the advertising attempts to accomplish and then evaluate the integrated message. Ironically, this range of factors arms the FDA with sufficient ammunition to determine the advertising as misbranding and term it illegal.  The speaker will suggest the ways of tackling issues like this.

Casper will talk about these issues in depth at this webinar. He will cover the following areas:

o  FDA’s approach to DTC advertising and promotion principles

o  FDA guidance and use of cognitive psychology

o  Types of violation for illegal DTC advertising practices

o  The role of sales and marketing departments

o  Executives’ legal liability.

FDA’s thinking behind 21 CFR Part 11 inspections

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in 21 CFR Part 11 to ensure that they can be considered as being equivalent to paper records and handwritten signatures.

The following come under the purview of Part 11:

o  Biologics developers

o  Biotech companies

o  CROs

o  Drug makers

o  Medical device manufacturers

o  Other FDA-regulated industries, with some specific exceptions

In other words, the provisions of 21 CFR Part 11 apply to organizations the life sciences industry. The provisions of 21 CFR Part 11 apply to areas that come under FDA regulated areas of research, such as researching, carrying out clinical studies, manufacturing, distributing and maintaining products.

The FDA has spelt out its best practices guidelines with regards to 21 CFR Part 11. These cover the following areas:

–       The Standard Operating Procedures (SOPs) and controls that go into supporting electronic records and signatures, which include measures such as, but are not limited to security, Computer System Validation and data backup

–       The steps taken for ensuring the security of the computer system have audit trails for creating and tracking data values, which make electronic signatures reliable and trustworthy

–       Steps to show proof that the system works according to what it is intended to, for which validation and documentation should be offered. Into this, the feature of helping users determine when a system is not working as it is intended to is also built in.

Punitive actions from the FDA on the rise

Experience has shown that 21 CFR Part 11 is an area in which the FDA has seen a high number of citations and other punitive actions. In only the last three years, the FDA issued no fewer than 30 Warning Letters that saw Part 11 violations. These actions have concerned not only the core areas of 21 CFR Part 11, namely integrity, availability and security of data; but also to validation of software and computer systems.

These findings are the result of the FDA’s renewed efforts at inspection and enforcement of Part 11 requirements. What makes these facts about the FDA actions intriguing is that for most part, these citations are against the Predicate Rules, rather than against Part 11 per se. All this lends credibility to the belief that there is widespread confusion about what the FDA is actually looking for in its inspections.

A useful learning session on Part 11 compliance

If companies in the life sciences industry, who are subject to Part 11 inspections, have to avoid these citations from the FDA; they need to first of all get a clear idea of what 21 CFR means and the reason and the manner in which it is being implemented. They next need to understand the enforcement part of Part 11 inspections from the FDA’s perspective. A grasp of these matters will help them prepare their company for Part 11 inspections.

The ways of getting these aspects right constitute the core of learning session from Compliance4All, a highly popular and renowned provider of professional trainings for all the areas of regulatory compliance. At this webinar, Angela Bazigos, a highly experienced regulatory compliance professional who brings over four decades in the industry, will be the speaker.

To steer clear of the entire muddle behind the Part 11 compliance, just enroll for this webinar by visiting      http://www.compliance4all.com/control/w_product/~product_id=501346?Wordpress-SEO

In the process of giving a clear understanding of how to implement the provisions of 21 CFR Part 11 in a way that avoids actions from the FDA; Angela will be covering the following areas at this webinar:

  • 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
  • Part 11 Basics
  • FDA’s view of 21 CFR 11 Compliance
  • FDA Acceptance of Data: Electronic & Paper
  • Computerized systems and eData
  • Basis for Part 11 Compliance and purpose of protection and validation
  • Diverse nature of “source” and how to protect and preserve it
  • Purpose and goal of 21 CFR 11 BIMO inspection
  • Inspection of electronic records – BIMO
  • The 10 Deadly Sins that break compliance
  • Examples of 21 CFR 11 Citations
  • How to prepare your company for successful part 11 inspections.

https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm

https://www.microsoft.com/en-us/TrustCenter/Compliance/FDA#

Proper handling of Out of Specification (OOS) result is the hallmark of a robust investigation

The whole exercise of drug making is incomplete and unthinkable without laboratory testing. There is no better indicator of success on the part of the drug manufacturer than this activity. This is absolutely essential as a means for confirming that all the ingredients that make a laboratory product, such as the raw materials used in it, the in-process materials as well as the finished materials that go into it, and containers as well, all kowtow to the set, required specifications. This is why current Good Manufacturing Practices (cGMP) regulations are very stringent and uncompromising when it comes to laboratory testing.

Now, what does a laboratory do when its laboratory testing comes up with an Out of Specification (OOS) result? It is necessary to understand that an OOS is not something that is taken lightly. It is taken very seriously and handled very stringently by the FDA. Being the regulatory watchdog under whose watch the whole range of laboratory activity falls; the FDA is carries out laboratory operations extremely closely. It expects complete and total compliance with its requirements on the way laboratories are expected to investigate Out of Specification and Out-of-Tolerance observation investigations.

Under FDA’s Sec 211.165, cGMP regulations reject any finished Out of Specification products that do not comply with the set specifications, as well as its mandated safety and other quality standards. These cGMP regulations also mandate complete investigation of test results that demonstrate any deviation of the contents of a batch from the specifications. These cGMP rules apply irrespective of whether batches have been released into the market or not.

How do labs deal with OOS results?

The application of current Good Manufacturing Practices into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals is required under FDA’ Section 501(a) 2 (b) of cGMP guidelines on OOS. OOS testing is mandatory for any batch that is being released.

These are what cGMP regulations require laboratories to do when they observe and confirm an Out of Specification testing compulsory for the release of a test batch: Confirmation of an Out of Specification result causes the batch to get rejected. If a laboratory test result throws up an element of ambiguity, then cGMP regulations require the company’s Quality Assurance (QA) to both mention the reasons for the release and to offer justifications for it.

The FDA guidance on Out of Specification covers human drugs, biology and biotechnological products, combination products, veterinary drugs; type medicated articles, transplantation of human tissues, medicated feed, finished products & active pharmaceutical ingredients and dietary supplements.

A learning session on the vital aspects of OOS

These aspects of OOS results will be the topic of a highly interesting and valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this webinar, Danielle DeLucy MS, who is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance, will be the speaker.

To enroll for this webinar and to gain complete understanding of how to handle OOS test results, please visit http://www.compliance4all.com/control/w_product/~product_id=501333LIVE?Worpress-SEO

The aim of this webinar is to guide attendees through the entire process starting from detecting an OOS result to launch and completion of informal and formal laboratory and batch investigations. This will help companies understand where they are going wrong, as it has been consistently observed that most companies do have procedures in place, but these are either inadequate or are not followed.

At this webinar, Danielle will professionals in the area of lab testing, such as Quality Assurance/Quality Control Directors, Managers, and Specialists, Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists, as well as Quality Control Laboratory Staff the responsibilities of analysts and supervisors. She will also enlighten them about how to listen to what the FDA looks for in terms of human errors, which will give them a good idea of what to do and what to avoid. She will also explain the situations in which a full investigation should be triggered, the frequency for re-testing and re-sampling, and the proper ways of implementing corrective and preventive action (CAPA) plans.

http://www.fda.gov/downloads/drugs/guidances/ucm070287.pdf

http://sphinxsai.com/2013/JulySept13/phPDF/PT=11(943-948)JS13.pdf

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?

This is simply not the case. Quality and compliance are built into a medical device product. It is only that companies need to have the capabilities needed for meeting Quality and compliance requirements from a regulatory perspective. If medical device companies have to be successful in their endeavors in the future, they have to be adept at how to meet quality and compliance requirements set out by the FDA.

Quality and compliance to meet regulatory requirements

Why is this needed? Simple: If medical device companies do not meet regulatory requirements set out by the FDA; they are not likely to meet the quality requirements demanded of their products. As a result, apart from being unable to create products that appeal to customers, they could end up facing punitive actions from the FDA.

As said, meeting Quality and regulatory compliance requirements is not something of a gamble. Quality and compliance, which are the key inputs for meeting customer demands, can be fulfilled by putting a thorough process in place. These are capabilities a medical device company needs to have if it has to meet quality and compliance requirements and succeed in the market.

Learn the ways of meeting Quality and regulatory requirements from the expert

The method by which medical device companies can achieve regulatory compliance requirements and ward off punitive actions from the FDA will be taught at a very interesting and lively webinar from Compliance4All.

The speaker of this webinar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will demonstrate just what medical device companies need to do in order to meet Quality and regulatory compliance.

To gain complete insights into how medical device companies can take the requisite steps needed for meeting quality and compliance requirements, please enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501160?Wordpress-SEO

An explanation of the seven capabilities needed for meeting quality and compliance requirements

At this session, Susanne Manz will explain that there are seven capabilities that are needed for medical device companies to accomplish their aim of meeting Quality and regulatory compliance requirements. She will explain these and offer complete understanding of how the changing regulatory climate needs to be comprehended. She will show how to evaluate one’s capabilities to develop a regulatory strategy that will help companies meet their requirements, so that they become successful in the pursuit of their objectives.

Susanne will show how to develop strategy from one’s self-awareness of the Quality and regulatory requirements. At this webinar, she will cover the following areas:

o  Evolving Regulatory Climate

o  Seven Key Capabilities for Success

o  How to evaluate and map your capabilities

o  Quality Planning and Improvement

o  Maturity Modeling

o  Developing Your Quality and Compliance Strategy.

Developing effective legal writing skills for FDA submissions

Effective legal writing skills for FDA submissions need to be nurtured for a number of valid reasons. This is because the documents that go into FDA submissions are highly technical and heavy in nature. When companies make submissions to the FDA, they submit highly complex studies that are very scientific and technical. When professional who work in this field seek to make submissions to the FDA; effective legal writing skills for FDA submissions go a long way in making these documents comprehensible and palatable.

Most law schools prepare future attorneys by inculcating into them the art of condensing and finessing complex and heavy textual and academic matter into crisp, succinct and persuasive arguments. These kinds of writing skills are all the more important when the company has to draft responses and applications to FDA. Since these responses are expected to be highly precise and put forth arguments that are of a highly scientific and technical nature; developing the art of effective legal writing skills for FDA submissions is a must.

Making submission documentation free of heavy text

Making submissions about the product is not the only reason for which effective legal writing skills for FDA submissions need to be imbibed. There is another important one, which is that companies have to wade through a maze of heavy, often confusing regulations. These regulations are legally binding requirements that are based upon statutory laws and judicial opinions.

On most occasions, professionals in the pharmaceutical and medical device companies need to deal with these and respond to these at required times. To do this, they need to have a full grasp of these requirements if they have to clearly understand, and have to effectively use effective legal writing skills for FDA submissions to frame persuasive argument and to negotiate with the FDA.

Effective legal writing skills for FDA submissions can be the difference between success and failure of drug submissions

In fact, the use of effective legal writing skills for FDA submissions is so important that many a time, effective legal writing skills for FDA submissions can decide the difference between the success and failure of many new drugs, biologic or medical device projects.

The more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. This is because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities. Hence, effective legal writing skills for FDA submissions are utterly important for legal drafting skills when preparing quality and regulatory documents.

Learn the art of effective legal writing skills for FDA submissions

Want to discover all the aspects of effective legal writing skills for FDA submissions? These will be imparted at a webinar that is being organized by Compliance4All, a highly cost-effective provider of professional trainings in all the areas of regulatory compliance.

Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com will be the speaker at this webinar. To understand the importance of and to imbibe the skills needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting

http://www.compliance4all.com/control/w_product/~product_id=501217?Wordpress-SEO

Effective legal writing skills for FDA submissions can even override flaws in test results

At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success, to the extent of even making up for some lapses in their test results or other supporting information. While good regulatory writing will meet FDA branch-level requirements; effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.

At this webinar, Michalik will cover the following areas:

o  Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations

o  Step-by-step analysis of how to present both good and poor data in a persuasive manner

o  How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?

o  Tips and secrets to framing an argument that makes even poor data look good

o  Examples of good writing that can be useful templates for training and skills development

o  What you should never say in a quality or regulatory document?

Demonstrating Product Reliability

Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.

The parameters used for quantification of Product Reliability are:

o  MTBF or Mean Time Between Failures for products that can be repaired and used, and

o  MTTF or (Mean Time To Failure) for products that cannot be repaired.

If these are the parameters used for quantifying Product Reliability, how does one predict it? Quality professionals use a relatable analogy to explain how to assure measurability of Product Reliability. This is known as the bathtub curve analogy, where the start or early life of the product is placed at the start of the bathtub. As the product starts getting used, it moves on to the phase of its useful life, from where it moves on to its wear out time.

The time taken for each of these processes is the indication of Product Reliability. Product reliability using the bathtub curve analogy suggests that at the beginning of the product lifecycle, the probability of failure rate is relatively less. As the product progresses on to its next phases, the probability of failure rate increases. This is the root of the understanding of predicting Product Reliability. Mathematical formulae are used to describe these.

How does on get Product Reliability right?

The ways of choosing the right reliability parameters for failure rates of respective products and estimating their lifecycle in the light of failure rates will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Steven Wachs, Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity, will be the speaker. To benefit from the experience Steven brings into Quality, please register for this webinar by logging on to

 

http://www.compliance4all.com/control/w_product/~product_id=501164?wordpress-SEO

A description of the various approaches to Product Reliability

Steven will offer and explain several approaches that can be used to verify whether reliability targets or specifications have been achieved at the desired level of confidence. In particular, he will describe the approaches using time-to-failure data to estimate reliability metrics.

Also taken up at this session, which will be of immense use to anyone with a vested interest in product quality and reliability, such as Product Engineers, Reliability Engineers, Design Engineers, Quality Engineers, Quality Assurance Managers, Project/Program Managers, and Manufacturing Personnel are demonstration tests, where minimum reliability may be demonstrated with zero or few failures.

A description of the methods that increase the risk of failures

Steven will discuss the kind of methods, which when used, increase the risks of field failures due either to inadequate designs or misconstruction of product use conditions that need to be managed. He will also offer the options for verifying and demonstrating that customer reliability requirements have been achieved.

Steven will cover the following areas at this webinar:

o  Overview of Reliability

o  Reliability Metrics and Specifications

o  Estimating Reliability with Time-to-Failure Data

o  Confidence Intervals and Bounds

o  Demonstrating Reliability with zero or few failures

o  Tradeoffs between Testing Time and Sample Size

o  Impact of Assumptions on Test Plans

o  Improving Demonstration Test Power

http://ftp.automationdirect.com/pub/Product%20Reliability%20and%20MTBF.pdf