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.

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.

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.

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.

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

Packaging and labeling are important components of commercial and clinical products

Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.

Commercial products have their own value over time. The FDA has guidances for commercial pharmaceutical products. Subpart G of CFR 21, Vol 4 concerns itself with packaging and labeling control. In line with its guidances on many related topics, this section deals with requirements for how labeling and packaging have to be carried out. These are some of the FDA’s rules on this topic:

o  Written procedures that describe how the labeling and packaging materials are received, identified, stored, handled, sampled, examined and tested and followed

o  Rejection of labeling and packaging materials that do not meet specifications or fail to meet their purpose

o  Maintenance of records of packaging and labeling for each shipment

o  Putting proper labels for each pharmaceutical product that describes the ingredients, strength, dosage and expiry date clearly

o  Destruction of expired products

o  Cancellation of license for pharmaceutical commercial products that fail to meet these requirements

The role of packaging and labeling in clinical trial products

Given the importance of clinical trials, and considering another equally important factor –namely that they are conducted across the globe these days –the need for extreme stringency in the packing and labeling of clinical trials products can never be overstated. In the area of clinical trials, these are the most popular packages:

o  Blisters

o  Bottles

o  Pouches

o  Syringes

o  Tubes

Irrespective of which of these packaging forms one is dealing with; there are stringent regulations for how to handle the packaging and labeling of clinical trials products. These regulations require manufacturers to maintain patient-friendly packaging and maintain strict standards concerning the following activities:

o  Filling of the product

o  Assembling it

o  Sorting it

o  Ensuring stability and containment of the product

Learn about the topic of packaging and labeling

All the nuances of packaging and labeling in the commercial and clinical products arena will be taught at a meaningful and educative webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Peggy J. 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. Please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501226LIVE?Linkedin-SEO

Teaching on all the key elements of packaging and labeling for commercial and clinical trial products

Peggy will introduce all the elements of packaging and labeling for commercial and clinical trial products at this webinar. The ways of transforming a protocol into an optimal package design will be one of the main constituents of this session. She will complete a review of the compliance requirements between commercial and clinical packaging and labeling, as well as a case study of changing commercial packaging for optimization.

Key personnel in the pharmaceutical commercial and clinical trials areas, such as    manufacturing personnel, quality and compliance personnel, regulatory personnel and clinical operations, will gain immense insights into this subject at this webinar, since Peggy will discuss all the core and auxiliary topics of commercial and clinical trials packaging and labeling, such as

o  Laws and regulations related to packaging and labeling

o  Guidelines implemented during commercial and clinical packaging and labeling

o  Implementing SOPs to ensure compliance

o  Implementing appropriate change control procedures

o  Selection of materials for packaging and labeling

o  Required submission content for the IND/NDA related to packaging and labeling materials and procedures

o  Commercial packaging compliance

o  Commercial labeling compliance

o  Clinical packaging compliance

o  Clinical labeling compliance

o  Change control for materials, design and content

At this session, the speaker will cover the following areas:

o  Commercial packaging compliance

o  Commercial labeling compliance

o  Clinical packaging compliance

o  Clinical labeling compliance

o  Change control for materials, design and content)

o  Pharmaceutical (drug/biologic).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.7

http://pharmaceuticalcommerce.com/manufacturing-and-packaging/clinical-trial-logistics-and-packaging/

How the supposed microbial control or monitoring approach SHOULD be handled.

That water systems are critical to the pharmaceutical industry is a given. This fact makes it absolutely imperative for pharmaceutical companies to get a grasp of the techniques needed for getting these systems right. Product recall, costly downtime and many other related negatives are some of the consequences of not getting these matters right.

Among the primary causes, on account of which pharmaceutical companies get their water systems wrong, is the number of water system biofilm control and microbial monitoring myths that dominate the industry. Pharmaceutical water systems experts are often in awe of the level to which myths have permeated the industry, to the extent that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are simply completely wrong. They are often bemused at how traditions that could be so totally wrong are so strongly rooted, misguiding practitioners in the industry.

Understand water system biofilm control and microbial monitoring myths and know how to defeat them

Busting these often dangerous water system biofilm control and microbial monitoring myths is the core of a webinar on pharmaceutical water systems that is being organized by Compliance4All, a highly popular provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the world-renowned expert on pharmaceutical systems, Dr. Teri C. Soli, will be the speaker. Dr. Soli, who is Principal Consultant at Soli Pharma Solutions, will take participants through all the myths that have been prevalent in the water systems industry for so long.

In order to understand the nature of water system biofilm control and microbial monitoring myths and subsequently get your pharmaceutical water systems right, just register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501243LIVE?Wordpress-SEO

Destroying water system biofilm control and microbial monitoring myths one by one

As a first step to shattering water system biofilm control and microbial monitoring myths, Dr. Soli will zoom in on the many reasons that have resulted in the perpetuation of these myths. But whatever the cause, one needs to be aware of the myths and understand how to do away with these.

He will lay threadbare each of the common water system biofilm control and microbial monitoring myths that are doing the rounds in the pharmaceutical water systems industry. He will be discussing the water system biofilm control and microbial monitoring myths that are related to microbial control approaches as well as microbial monitoring.

He will take up each myth, trace and explain its origin, and then put how the supposed microbial control or monitoring approach should be handled into true context, rather than how it is being handled.

In this session on water system biofilm control and microbial monitoring myths, Dr. Soli will cover the following areas:

  • Why water myths develop
  • Impact of c-GMPs
  • Well-meaning but misguided precedents
  • Scientifically unchallenged traditions and benchmarking
  • Rule-hungry culture
  • Water System Microbial Control Myths
  • WFI from RO
  • Turbulent Flow and Flow Rate
  • Dead Leg Rules
  • Smooth Surfaces
  • In-Line Sterilizing Filters
  • Ozone
  • Microbial Enumeration Myths
  • Referee Methods
  • Thermophiles in Hot Systems
  • R2A, 35°C, 5 days
  • Test Filter Membrane Rating
  • Compendial Action Levels
  • TOC and Endotoxin as Microbial Count Correlates.