Webinar Calendar of Upcoming Courses – May to Jun 2017

webinar-training-online-education.jpgBelow is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

the most erudite experts on regulatory compliance being available at a click

in the comfort of your preferred location; regulatory compliance could not

get any simpler and effective!
Compliance4All’s experts help you unravel all the knowledge you need in all

the areas of regulatory compliance. They help professionals like you

implement the regulations and stay updated, so that regulatory compliance

causes no stress for you. Compliance4All’s experts offer their insightful

analysis into the issues that are of consequence to regulatory professionals

in their daily work. Their thoughts help you implement the best practices of

the industry into your work. They also offer updates on the latest regulatory

requirements arising out of a host of the laws and issues related to

regulatory compliance, such as Pharmaceuticals, Biologics, Healthcare, Food

and Beverages, Software, Embedded Technologies, Energy and Utility,

Payment Card Industry (PCI), and lots more.
Take a look at our upcoming webinars from Compliance4All, which will put

you on the road to learning about any area that is of importance to your

profession. You can plan your learning from Compliance4All by looking at

our events in the next few weeks. You can choose from a whole range of

topics. See which among these trainings suit you: FDA Regulation of

Medical Device Software, Conducting Successful Product Complaint

Investigations, CAPA, Failure Investigation and Root Cause Analysis, 1099

and W-9 Update, Laboratory-Developed Tests, avoiding an FDA 483,

Equipment Validation, and much more!

For more Calendar Webinars http://www.compliance4all.com/control/webinars_home

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.

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.

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.

How to implement technology transfer in pharmaceuticals

Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.

Technology transfer is carried out in a number of areas. In universities, which are breeding grounds for new ideas, technology transfer is carried out to help the product reach out to the market. In the field of intellectual property (IP), technology transfer is the means by which a patent or a copyright or a trade secret is licensed to be exploited for commercialization.

In pharmaceuticals

Technology transfer is a major component in the field of pharmaceuticals, as well. In the field of pharmaceuticals, the method by which technology transfer is done is important. Correctly describing the methods and processes of technology transfer is extremely important to prevent any major deviations or misunderstandings between the parties at a later date. The aim of exploitation of technology, patent-protected or otherwise, in this field is to help the product reach out to the larger market, so that the general public benefits from the invention or innovation. Defining the terms by which the commercial gains of the technology transfer will be shared is also important.

If a pharma product is to become successful; its transfer and that of its processes has to be handled extremely well for the product to enjoy a successful launch. Only this ensures that pharmaceutical products of the highest quality are delivered to the patients, and also that they meet the expected business goals.

Yet, executing the technology transfer is complex even in these days of legal protection for IP. Technological transfer of pharma products involves the interactions of many disciplines across an organization. While carefully developing, managing, and transferring of technical and business knowledge is one aspect; the development of processes and steps for defining the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems is another.

A learning session on pharmaceutical technology transfer

The ways of handling this whole process of technology transfer in the field of pharmaceuticals will be the teaching a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance will be organizing.

The speaker at this webinar is Steven Laurenz, a senior pharma professional who brings over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization.

To enroll for this webinar and gain the benefit of hearing from this seasoned professional, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501257LIVE?Wordpress-SEO

The technology transfer process

The aim of this session is to introduce the concepts associated with implementing a carefully defined technical and business governance program. Along with this, Steven will also suggest a clearly defined R&D process to chart technology transfer steps for successful implementation. The concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge, will all be covered at this webinar.

These are the objectives that this webinar will help the participants achieve:

o  Define technology transfer

o  Identify elements of the business process framework for managing technology transfers

o  Identify New Product transfer process

o  Explain benefits of technology transfer

o  Determine elements of a successful technology transfer

Steven will cover the following areas at this webinar:

o  The importance of technology transfer

o  The use of a technical review system to update and review technology knowledge obtained during drug product development

o  The use of a Product Strategy Review system to review important business aspects in preparation for transfer

o  Tools and Templates used for technology transfer.