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.

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

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Compliance4All’s experts help you unravel all the knowledge you need in all

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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.

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.

EPA’s new Revised Section 608 Refrigerant Management Regulations

In late 2016, the US Environmental Protection Agency (EPA) revised Section 608, which deals with refrigerant management regulations. A number of requirements under this section are set to change. They concern the handling requirements that are applicable to ozone depleting refrigerants, and fortify the existing regulations by incorporating a number of best practices to extend these to hydrofluorocarbons (HFCs).

The EPA has estimated that these revisions, when implemented, will cut down emissions from products such as refrigerators and air conditioners, which have a detrimental effect on the climate, to the tune of 7.3 million metric tons of carbon dioxide equivalent (MMTCO2eq) and 114 ozone-depletion weighted metric tons (ODP tons) annually.

The Rule in a nutshell

Set out with the intention of reducing the emissions from refrigerants of ozone-depleting substances; the essence of the new EPA rule can be summarized under the following:

–       The Refrigerant Management Program has now been enlarged to include substitute refrigerants such as HFCs. A few such substitute refrigerants were exempt earlier from Section 608

–       It sets a lower leak threshold for ozone-depleting implements such as refrigerators and air conditioners that contain 50 lbs. or more refrigerants. This is the new, lowered leak threshold slab:

o  30% for industrial process refrigeration (IPR) from 35%

o  20% for commercial refrigeration equipment from 35%

o  10% for comfort cooling equipment from 15%.

–       Additionally, the new revised Section 608 requires quarterly or annual maintenance leak inspections for equipment that exceed the threshold leak rate limit

–       It also requires operators and owners to report systems that exceed the limit of 50 lbs. or refrigerant leak by one and a quarter times in a year

–       It defines products whose sale is restricted because of the excess leak rate.

–       The new revised EPA Section 608 also requires technicians to document the refrigerant that they recover during disposal for systems that have a charge size varying from five to 50 lbs.

Gain clarity on the EPA’s new revised Section 608

All the ways of understanding and practically implementing the provisions of the EPA’s new revised Section 608 will be offered with clarity at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

This webinar will have Keith Warwick, a professor at Yuba College in Marysville California and instructor at the University of Washington, who has significant experience teaching engineering, safety and related subjects, as speaker. To understand the nitty-gritty of the EPA’s revised Section 608 and ensure that you do not invite punitive actions from the agency, please register for this webinar by visiting EPA Section 608

Delving into all the aspects of the new revised Section 608

This webinar will discuss all the elements pertaining to the EPA’s new revised Section 608, such as technician certification, refrigerant sales restriction, service practices, recovery and recycling equipment, recordkeeping, repairing refrigerant leaks, appliance disposal, and refrigeration reclamation.

Keith will also explain how ozone depleting substances (ODS) are split into two groups under the Clean Air Act, class I ODS such as chlorofluorocarbons (CFS) and class II ODS such as hydro chlorofluorocarbons (HCFC).

The major gain of attending this webinar is that it will help the participants to understand the EPA’s new revised Section 608, which will help them to avoid violations, citations and fines. Violations of the EPA’s new revised Section 608 leads to citations which require addition of physical improvements, which can be expensive. The EPA can also shut down a facility for an extended period.

Keith will cover the following areas at this webinar:

o  General discussion of the Clean Air Act

o  How to utilize consultants

o  Technician certification

o  Refrigeration reclamation

o  Recovery and recycling equipment

o  Regulatory involvement with facility and process

o  Discussion of class 1 ODS

o  Discussion of Class 2 ODS.

Paper records to electronic for pharmaceutical companies

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper records has been noticeable.

Many differences between paper and electronic records

One of the defining differences between this electronic standard and traditional paper records is that while the latter used to be stored in a central, protected environment and managed by a designated managers; electronic records are spread over many locations.

Although some are managed by a central authority; most are under the control of individuals. Individuals in charge of this work have a wide range of computer based devices such as phones, laptops, tablets and USB storage devices at their disposal, which can be used for functions such as authoring, storing, and copying and transmitting relevant information.

Also, the information available on these systems can be stored and shared within several locations on the web, with the option of protecting some better than others. What has also changed substantially is the process of verifying the authenticity of a record. Earlier, the method used to authenticate paper records was via inked signatures of the author and witness. Encrypted e-signatures are replacing this practice.

Submissions to the regulatory authorities

In line with this development, the FDA and other global regulatory agencies started accepting electronic files, or at least parts of submissions, for testing and marketing drugs. This movement, which started in the early 1990’s, led to the creation of the Common Technical Document (eCTD) standard. This standard is now required in the US and most countries around the world.

If pharmaceutical and life sciences companies have to submit documents such as the NDA, ANDA, IND, BLA, DMF and the BMF to the FDA electronically, the eCTD has been the pan-industry, widely accepted standard since 2008. Submissions are, in fact, no longer done via paper records. If companies have to incorporate legacy paper records into an eCTD; they have to scan those and put them into a text readable format.

A source of important information

Despite the existence of this method; many companies continue to possess huge troves of paper based information, which are yet to enter the cyber realm. These records contain important information relating to the pre-clinical, clinical and drug safety paper records of drugs that did not make it to the marketing stage for a variety of reasons, because of which these companies have archived this information.

This archived data, if harnessed effectively, could be a rich source for offering knowledge that will go on to enhance inputs for submissions for other new or emerging indications for the drug or support efficacy or safety for related drugs. Many organizations have a large collection of paper records with retention times of 50 years or more. There is a dilemma of how to best preserve and utilize these records.

What is the way of going about for transiting?

Many companies are in a quandary about what to do in a situation in which the majority of records are electronic, but a substantial number remain as aging paper records. If the wealth of information available in paper format is to be exploited meaningfully, should they convert all the paper records to an electronic format, convert some of them, or just leave them in their current form? Given that complete conversion and subsequent integration is a very expensive and laborious exercise; a better option will be to convert on an as-needed basis.

The ways of how to do this effectively will be the topic of a highly educative webinar from Compliance4All, a provider of professional trainings for all the areas of regulatory compliance. At this webinar, Dr. Charlie Sodano, an experienced, globally recognized information management professional who launched eOrganizedWorld a consulting firm specializing in the planning and implementation of records and information management systems, will be the speaker.

To understand and have these issues resolved from the expert, please register for this webinar by logging on to Records policy and procedures

Dr. Sodano will take up and explain the issues relating to conversion of paper records into electronic, and the ways in which the submissions need to be made. This training is of importance to professionals in Research & Development, Regulatory, Clinical, Legal, Information Technology and Validation.

During the course of this session, Dr. Sodano will cover the following areas:

o  Records policy and procedures

o  Records data map

o  Incorporating paper records into a eCTD

o  Converting paper documents into a useful electronic format

o  Scanning costs and resources

o  Indexing and organizing scanned records and integrating them

o  Long term record storage and retrieval.