About 7 decades since the FDA was first formulated in its earliest avatar

Considering the slew of regulations that exist for medical devices today –to the extent that this is among the areas of the highest regulation from the FDA –it is rather ironical that the US Congress had not empowered the FDA to regulate medical devices till as recently as mid-1976. This is when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). This was about seven decades since the FDA was first formulated in its earliest avatar.

The reason for which medical device software started getting regulated during this time is that it was in the mid-1970’s that computer software started to grow and evolve into a field of its own. Being in a state of infancy for most of that decade; it was only towards the end of the next decade that software began to get used in medical devices, albeit in a manner that appears rather crude by today’s standards. Because of this, the FDA did not have the need to create a software regulatory policy.

Separate regulations based on the nature of devices and software

Since then, however, software has made giant strides in its uses in medical devices. The growth has been so fast and wide-ranging that today, there are regulations for:

o  Software that can be a device by itself (i.e., stand-alone, or what the FDA calls Software as a Medical Device or SaMD)

o  Software that is incorporated into another device as a component, part or accessory.

Other factors to be taken into consideration

So, the FDA’s regulations on medical device software are based on its thinking that there is a distinction between stand-alone software and software that is a component, part or accessory to a device. Also, software validation is a major theme for most manufacturers of medical devices. Software validation of medical devices has to be not just satisfied; it has to be evidenced from a number of stringent perspectives. There is a clear distinction between medical device software and medical device hardware. Additionally, there are design user requirements to be met, and off-the-shelf software and automated equipment have to be validated.

In the realm of clinical valuation of an SaMD; the FDA requires medical device manufacturers to meet and demonstrate reasonable assurance of safety, performance and effectiveness since these devices have a very major impact on the health and safety of its users. This clinical evaluation has to thus be thorough and systematic, and should be well planned. The FDA’s clinical valuation of an SaMD should meet the following:

o  Clinical validity

o  Scientific validity

o  Clinical performance

o  Analytical validity

Deep and clear understanding

Professionals who work in the field of medical devices and whose work is related in some or another way to medical devices need to be aware of the FDA’s regulation of medical devices. This requires detailed understanding of the regulations as they exist, as well as the knowledge needed to interpret and apply them into medical devices or software, whatever the case may be.

This is the understanding a webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be offering. Thomas E. Colonna, who provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics, medical device software and biotechnology-based products, and holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia, will be the speaker at this webinar.

To gain complete understanding of the FDA’s thinking on medical device regulation and to get a grasp of how to apply it for practical use, please register for this webinar by logging on to FDA’s Regulation of Medical Device Software

At this webinar, Dr. Thomas E. Colonna will offer fundamental understanding of FDA regulation of medical device software. Expectedly, this session will be of immense benefit to professionals at various levels in the field of medical devices and medical device software, such as Compliance Managers, Validation Managers, Regulatory Managers, QC Managers and QA Managers.

At this session, Dr. Colonna will cover the following areas:

o  Definition of medical device software

o  FDA’s medical device software regulatory scheme

o  Software validation

o  Level of concern.

Meeting labeling requirements of various drug products

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FP&L Act) are the laws that manufacturers of these products need to comply with in order to meet labeling requirements of these products. These laws are separately made for a number of products and their subcategories, such as drugs, cosmetics, cosmetics that are also drugs, and so on. In addition, the regulations set out by the EMA also need to be complied with by manufacturers of these products, if they plan to market to the EU markets.

One of the elementary requirements of the FDA is that the ingredients of the cosmetics must be declared prominently. By this definition, the prominence should be such that users should be able to see the declaration when they purchase and see the product. The FDA prescribes that the letters in the ingredient declaration should be not less than 1/16 of an inch in height. In cases where the total package surface available for labeling is less than 12 sq. inches, the height of the letters must be at least 1/32 of an inch.

Particular about the specifications

The FDA also requires that the ingredients must be declared in descending order of importance. Color additives must be declared too, but does not require an order of prominence. The active ingredients, as well as the additives, must be clearly declared. Labels should carry warnings when they carry ingredients that are likely to cause damage to some or another part of the body. Products such as aerosols, deodorant sprays used by females, and soaps and other cosmetics used by children have their own labeling requirements.

If all this is a snapshot of the only the prominent labeling requirements for just cosmetics, imagine the kind and variety of requirements that need to be met for all other related products such as medical devices, drugs, vitamin supplements and many others. And what about understanding the EMA’s requirements?

Knowledge of the labeling requirements of the products need not be intimidating, because this is the content of a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Learning session on labeling

The speaker at this webinar is Salma Michor, who is founder and CEO of Michor Consulting Schweiz GmbH, which serves such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. The full extent of Salma’s experience will come into play at this webinar. To register for this session and to benefit from the wealth of Salma’s experience, please register by logging on to Labeling Drug Products

This webinar will focus its attention on the ways by which to remain compliant with the labeling requirements of the various regulatory bodies vis-à-vis a number of products. Salma will explain the challenges associated with remaining compliant with the labeling requirements of products such as generics, prescription drugs, OTC drugs, medical devices, vitamin supplements, traditional herbal remedies, foods, cosmetics and biocides, and will suggest ways of dealing with them. She will focus in particular on the EU requirements for labeling of these products. Regulatory Affairs and labeling specialists will understand the intricate details of the labeling requirements for these products at this webinar.

Regulations governing how combination products are regulated

The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.

21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one that is made by combining:

o  A drug and a biological product

o  A drug and a device

o  A biological product and a device

o  A drug, a biological product and a device

A combination drug is one that becomes a single product and is obtained by combining any of the above.

The FDA has a number of regulations on combination products that drug, medical device and biological companies need to show compliance with. 21 CFR Part 3 has regulations that relate to how companies need to assign their combination products to the FDA for review, and Part 3.4 explains how the FDA goes about in its work of designating the review of these products.

Recent regulation from the FDA

The FDA passed a recent regulation: the Final rule on postmarketing safety requirements for combination products, on December 20, 2016. This Rule, which came into effect from January 19, 2017, sets out the postmarketing safety reporting requirements for products

o  That are termed as constituent products, meaning the parts of the drug or devices or biological product that go into a combination product

o  Which are deemed as combination products since two or more different types of regulated products have gone into it, and whose constituent parts have received an FDA marketing authorization.

The FDA’s regulations for devices, drugs and biological products have many similarities. Yet, there are unique and different standards, reporting requirements and timeframes for each of these regulations. It is to harmonize the variations in these standards, which the FDA believes result in inconsistent and/or incomplete reporting relating to post-marketing safety, that the Final Rule came into effect. It seeks to bring about consistency and completeness in the safety reporting requirements of post-marketing activity of these products and avoid repetitive reporting for combination products that have received FDA marketing authorization.

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An understanding of the complexities and intricacies of combination product regulation

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will give a thorough understanding of combination products and their regulations. The speaker at this webinar, Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm which is in its twentieth year of business, will be the speaker.

To gain clarity on the regulations that govern combination products, please register for this webinar by visiting How combination products are regulated

Learning session with value add-ons

Charles will offer valuable learning during this session for professionals who are currently involved in the manufacture of combination products or are about to submit products in the near future for approval. Charles will explain all the facets of combination products, beginning with their definition. He will explain the complexities associated with these kinds of products to an organization from the perspective of the constituents of the combination product and give an understanding of how to overcome them.

Charles will also present scenarios that will discuss how and which regulations apply based on the device and the kind of facility manufacturing it. He will facilitate easier understanding of the complex process of regulation application by providing a job aid that will be a value addition to this webinar.

Different regulations for different combination products

In explaining the various regulations that govern combination products; Charles will explain how the regulatory process applies to them, since the approval process for a purely medical product varies from that of a purely biological or a purely pharmaceutical product. He will also review the kind of actions that attract 483’s from the FDA to give a clearer understanding of the approaches for GMP and regulatory applications.

Charles will cover the following areas at this session:

o  Definition of Combination Products

o  Combination Products and US Regulations

o  Combination Product Approval Process

o  GMPs for Combination Products

Warning Letter Case Study Review.

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

Ensuring compliance with drug advertising promotional claims requirements

Advertising is a highly challenging and creative field. However, when making claims about the efficacy and effectiveness of products, especially drug products, advertising professionals need to comply with strict compliance guidelines which set out the limits of claims. The US government lays considerable stress on the veracity aspects of the advertising claims.

An ad for a drug product must state not just the benefits of a product, but also its side effects, risk and a lot other information such as the product ingredients, generic name/s, and proper indications of use. In addition, the image of models shown for the product should be inappropriate.

It should represent the correct age group for which the product is prescribed, and should not show a model of any other age group in the ad. If a cough preparation is targeted at the teenage population, the ad image should show only a teenager as a model and not someone who is older or younger.

The FDA has many requirements on the validity of advertising claims

In addition, there is another very important requirement from the FDA: The print ad should ask the user to report a negative finding to MedWatch and should give the contact numbers of the agency to whom to report negative findings of the use of the drug. The ad promotion branding should also advice the user to seek medical opinion before using the drug, so that expert medical advice is taken and the patient does not take the drug at will.

Offering clarity on the gray areas of advertising and promotional material

These said, there is considerable confusion about the subjective, or what are called gray areas of advertising claims. The issue is how to interpret these gray areas of a product or the ad, which will make a difference to the user’s decision making.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will seek to clarify on these and other related areas of drug ad promotion.

Peggy Berry, who is the President and CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development, will be the speaker at this webinar. Over the course of this 90-minute session, Peggy will explain the requirements for compliance within the US. To benefit from the enormous experience Peggy brings into field, please register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501227LIVE?Wordpress-SEO

A description of all the issues relating to advertising and promotional material

She will explain the gray areas that must be evaluated thoroughly. She will show the ways of conducting a risk assessment and suggest and describe the strategies for mitigating risks and making challenging decision. She will familiarize participants with the critical situations and the important kinds of promotional materials in which advertisers could potentially get inputs and suggestions from regulatory agencies. She will equip participants with the knowledge needed for handling these situations. An understanding will be given of the important promotional materials and the strategies for implementing review processes and procedures to facilitate high compliance standards.

An important leaning offered at this webinar is compliance issues in the creation of advertising and promotional materials. Peggy will explain what needs to be done internally to assure assessment, evaluation and documentation of the advertising material.  Attending this webinar will ensure that the participants put in place an advertisement claims compliance program that will ensure full understanding and communication of potential risks associated with materials. The webinar will also give them the ability to mitigate risk through small but important amendments, which will go a long way in ensuring a high level of compliance standards by all the staff concerned.

Peggy will cover the following areas at this webinar:

o  Compliance Requirements

o  Submission Requirements

o  Prior to Approval

o  Direct to Consumer

o  Social Media

o  Medical Affairs

o  Sales Training

o  Review Process Considerations.

https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm082284.htm

https://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/guidances/ucm064956.htm

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major culprit when it comes to losses that many industries sustain in their quality and production. Technology has pervaded most industries in ways that were not imaginable a couple of decades back; yet, it is not likely that human error will ever be totally eliminated.

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Having said this, it is also true that it is possible to prevent several human performance problems. The starting point of human errors start is the design stage. Human reliability comes into play in a major way in procedures. The key to human engineering, improving and/or fixing and identifying exactly where the weaknesses in the procedures instructions lie is getting a grasp of human behavior and the psychology of error.

A learning session on all the aspects of writing for GMP regulations

An understanding of the weakness in procedures that harm productivity, quality and regulatory standing will be the major learning 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 Ginette Collazo, a human error and human behavior expert, who brings vast experience in the technical training, organizational development and human reliability areas. Interested in gaining insights into how to understand and reduce human errors in GMP procedures? Then, all that you need to do is to register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501285LIVE?Linkedin-SEO

Discussion of all the areas of human error in writing for GMP regulations

At this webinar, Ginette will discuss everything from content development to formats designed for human error reduction due to procedures. She will start with an outline of SOP writing and describe the role and possibility of human error in content development. She will also discuss the universal purpose of procedures in the background of regulatory compliance.

Ginette will expound the human perspective and the rational for procedure use and describe human error as a root cause. She will also explain the thinking and reading process and touch upon some common mistakes and causes.

Human error rates and measurement, the ways of creating and maintaining a procedure, as well as the goals of a procedure, will all be taken up.

Taking a glimpse at Good Procedure Writing practices

Another of the areas Ginette will traverse during the course of this very interesting session is Good Procedure Writing practices, during which she will dwell upon all its related aspects such as Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions”.

Finally, she will also explain procedure styles and the use of electronic information networks for procedure access. All in all, this promises to be a very educative and well-rounded teaching session. All the important people involved in GMP regulation and human factors, such as QA/QC Directors and Managers, Process improvement/excellence Professionals, Training Directors and Managers, those in Plant Engineering, Compliance Officers, Regulatory Professionals, people in Executive Management, Manufacturing operations Directors and Human factors Professionals, will all derive benefits in large measure from this webinar.

Are Your Test Methods Ready for Quality Control or any laboratory ?

The FDA considers verification and transfer of Test Methods a subject worthy of 483 observations and issuance of Warning Letters. Test method verification is also required by the GMPs, and USP has a whole chapter dedicated to test method verification. This makes comprehension of the requirements for the verification and transfer of a test method into a laboratory imperative for Laboratory Managers and other personnel.

In normal circumstances, the requirement for method transfer arises with the transfer of the method from the Method Development environment to the routine Quality Control testing laboratory. Ideally, however, the existence of method transfer any time a method is transferred from one laboratory to another should be in place, as this would also address and include the transfer of the method into more environments, such as a stability testing laboratory, or a contract laboratory or the testing laboratory of a contract manufacturer.

Support for verification of test methods

The US GMPS requires the verification of test methods under actual conditions of use to verify the suitability of all testing methods. The USP seconds this, stating that “Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use”.

The concept of method verification is also supported by a modified version of the accepted definition of test method validation, which requires documented evidence to ensure “that the test method performs as intended in the using laboratory”.

So, what does this mean for laboratories that have not performed the test before? Such firms must demonstrate something to prove that the test method performs as intended. This has to be done irrespective of whether the transfer is from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. All that is needed for the firm is to demonstrate that the receiving laboratory has the capability to perform the test, and also that the test results are an accurate reflection of the attribute being tested.

A learning session on method transfer and method verification

However, many companies do not understand what should be done for a thorough, successful test method transfer. A webinar from Compliance4All, a highly respected provider of professional trainings for all the areas of regulatory compliance, will explain all the intricacies of method transfer and method verification.

At this webinar, Jerry Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System, will be the speaker. In order to understand the complete nitty-gritty of method transfer and method verification, please register for this valuable webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501282LIVE?Linkedin-SEO

The term method verification acquired a new shape and meaning with the USP’s publication of its stimulus article on the test method lifecycle. This stimulus article proposes Continued Test Method Verification during stage 3 of the test method lifecycle. At this webinar, Jerry will discuss test method verification and what all need to be considered for the method verification project.

This learning, on all areas of method transfer and method verification, will be extremely useful and valuable for Laboratory Directors, Managers, Supervisors and Analysists in any laboratory performing GMP testing.

At this session, Jerry will cover the following areas:

o  The requirements for test method verification when a method is transferred from one laboratory to another

o  What might be included in the method verification that accompanies a test method transfer?

o  The regulatory and compendial expectation for test method verification as a part of the test method lifecycle

o  What might be included in continued test method verification?