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

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

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.

Use OneNote to manage your meetings

Microsoft OneNote is a program that works as a digital notebook. It saves users the trouble of having to scramble for a piece of paper whenever they feel like scribbling some information or idea down. Moreover, it saves the user the trouble of having to preserve a piece of paper on which the info is jotted down.

Microsoft OneNote helps users to type, write or draw on the digital notebook while continuing to have the same feel as a regular paper and pen. It is designed to help people have access to note down ideas or important information with the ease of a notebook. Users can also search the web and clip pictures to the text to enhance the effect. Several other features are available to add effect to the text.

Another feature of the Microsoft OneNote program is that the documents can be shared across the www. It helps to communicate ideas, thoughts and occasions across devices. It is available for a number of devices ranging from Apple to Windows and Android and the web.

Explore the ins and outs of Microsoft OneNote

There is a lot to explore in this program. This is what a learning session from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering at a webinar. The speaker at this webinar, Mike Thomas, has worked in the IT training business since 1989. He is a subject matter expert in a range of technologies including Microsoft Office and Apple Mac. He has produced nearly 200 written and video-based Excel tutorials. It is this rich experience that will be in full display at this webinar.

To learn the nitty-gritty of all the functions that you can get Microsoft OneNote to perform for your benefit, just enroll for this webinar by visiting Best practice for creating a Notebook

Business Professionals, Business Owners, Researchers, Administration Support Staff, Educators, for that matter anyone who wants to learn how to get the best from OneNote to manage projects and their life, will gain from this session.

Putting the program to maximum use

Mike will explain how to use OneNote notes thoroughly for storing text, images, videos, embedded files and drawings and sketches. He will show how to optimize OneNote notebooks for sharing with colleagues and customers and using it for thorough collaboration at work. The ways by which OneNote can be used to manage projects, meetings, and life itself will be taught at this session.

Mike will cover the following areas at this webinar:

o  Best practice for creating a Notebook

o  Restructuring and rearranging a Notebook

o  Protecting your information

o  Using OneNote for Internet research

o  Collaborating with others / Sharing a Notebook

o  Drawing, sketching and hand-writing notes

o  Searching OneNote

o  Integrating OneNote with Outlook

o  Go Mobile: How to use OneNote on an iPad.

FDA’s thinking behind 21 CFR Part 11 inspections

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

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

The following come under the purview of Part 11:

o  Biologics developers

o  Biotech companies

o  CROs

o  Drug makers

o  Medical device manufacturers

o  Other FDA-regulated industries, with some specific exceptions

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

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

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

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

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

Punitive actions from the FDA on the rise

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

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

A useful learning session on Part 11 compliance

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

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

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

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

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

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

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

Understanding the ways of conducting shrink investigations

Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.

Controlling losses is as important as making profits. In fact, it even precedes profit making. A shrink investigation is a means to understanding where the losses lie and what causes them. This should help them to formulate policies and procedures that help them do this. Mapping audit practices to established procedures is important in helping to identify the source of loss. A shrink investigation is ideal for serving these purposes.

A major means for controlling retail losses

A shrink investigation is very important when one considers the fact that a third of all retailers suffer losses that are both unidentified and uncontrolled. Most retailers fail to realize that carrying out a shrink investigation requires a sense of direction and purpose, periodicity, prolificacy, and proactivity.

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will help you expand your thinking and set you on new horizons of shrink investigation. This webinar will be presided over by the highly experienced and acclaimed expert on law enforcement, criminal investigation, loss prevention and fraud examination, John E. Grimes III.

To benefit from John’s wide-ranging and solid experience, register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501274LIVE?Wordpress-SEO

In this session that personnel connected with the retail industry, such as Small Retail Business Owners, Managers, Auditors, Loss Prevention Professionals and Fraud Examiners will find very useful, John will impart a clear idea of all the elements of a shrink investigation.

Learning on all the aspects of shrink investigations

Attendance at this webinar will equip participants with a crystal clear understanding of the process needed for conducting a shrink investigation. These include covert observation of the store; a review of policies and procedures; a review of practices that are in contrast to established best practice procedures; a review of point of sale data including refunds and voids; taking frequent inventories; delivery audits; and paperwork review.

During the course of this 90-minute session, John will cover the following areas:

·        What causes Shrink (Losses) in a Retail Environment

·        The importance of having overarching Policies and workable Procedures to control shrink.

·        Understanding the steps to perform a Shrink Investigation when the source of losses is not identified through normal business operations procedures and practices. This webinar will discuss the steps, which include:

o  Covert observation

o  Undercover shoppers.

o  Review of policies and procedures

o  A review of point of sale data

o  Store meeting

o  Employee Interviews

o  Surprise Delivery Audits

o  Paperwork review

http://blog.lpinnovations.com/Loss-Prevention-Leadership/bid/76560/4-Key-Fundamentals-to-Positively-Impact-Your-Shrink-Loss