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

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.

Cash management in ERP systems and Reconciling bank statements

Cash management is a major component in ERP systems such as Oracle. It is a module that offers information about the most critical component of the business, namely cash flow. Cash management processes and analyzes all of the business’ cash and bank transactions from a number of sources such as:

o  The payments made to a supplier as reflected in the invoices

o  The value of receipts got from the business’ sales invoices

o  Single or isolated payments not from any of these above categories

Another important role performed by the cash management module is that using it, the organization’s Finance personnel can analyze financial transactions of all kinds that happened during a selected period of time. Cash management in ERP also gives Finance the inputs that help them understand where the funds are coming in from, and how they need to be allocated and spent so that the company meets its payments-related obligations.

Functionality of Cash Management module

Usually, cash management modules in ERP systems are built to accommodate the following features:

o  Tracking Supplier Payment

o  Tracking the way in which sales invoice amounts receipts are made

o  Helping to forecast the cash flow

A learning session on cash management and bank statement set up and reconciliation

Do all these aspects of cash management sound confusing? It is to address these confusions and issues related to cash management that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.

Kevin Chenoweth, who has wide-ranging expertise in designing project plans for multi-million dollar Oracle R12 financial leading to under budget and on-schedule projects and has helped organizations complete full life-cycle implementations in the Oracle financials modules through effective leadership, will be the speaker at this webinar.

To hear Kevin offer his insights into cash management, which is a result of his having implemented Cash Management processes for both technology and manufacturing SMB and Fortune 500 companies such as Comcast and having addressed their particular challenges in streamlining their bank account structures and relationships to align them with their changing business structure and accounting systems; just enroll for this webinar by logging on to   http://www.compliance4all.com/control/w_product/~product_id=501331LIVE?Wordpress-SEO

The wealth of the speaker’s experience

During this course, Kevin will offer guidance and understanding about the fundamentals of Cash Management in ERP systems such as Oracle. Another important related activity, namely bank statement formats, will also be discussed, along with how to and when to apply them.

Kevin will discuss all the challenges associated with bank statement set up and reconciliation, namely how to handle various deposits in transit, outstanding checks, service charges, and non-sufficient fees. During this explanation, he will illustrate the experiences he had earlier in his career at organizations such as ComCast, where he helped prepare its merger with Time Warner with important works like streamlining its zero-balance accounts and regional banks.

Kevin will cover the following areas at this session:

o  Bank reconciliations for various types of transactions

o  Streamlining of accounts to match company strategy

o  Consolidation of accounts to match company strategy

o  Preparation of banking relationships for a merger

o  Zero Balance accounts and how to manage them

o  Understanding of cash flows in strategic initiatives

o  How cash flows interact with financial statements

http://www.managementstudyguide.com/cash-management-module-erp.htm

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#

Learn how to future-proof VLOOKUP by using Excel’s Table feature versus referencing static ranges

Professionals in a wide number of industries and businesses find the VLOOKUP function in Excel very useful. Why this is so is that it helps in locating an exact value. Using VLOOKUP, an MS Excel user can find a specific piece of information in the spreadsheet. This is very useful when there are very many values in a grid. In other words, the VLOOKUP function is ideal for locating an exact one from among a number of values. Using VLOOKUP, users can return data from other locations in a worksheet.

An indication of the functions that VLOOKUP performs can be had from its expansion, which is Vertical Lookup. It works by searching for the specific item in a vertical manner. As opposed to normal values that can be performed manually; VLOOKUP function helps users to go further by enabling them to perform more complex tasks such as unit sales for a period of time at a certain price or its variables.

If the user wants to calculate the unit sales of say, a clothing material from one date to another at a certain price; VLOOKUP is extremely handy. This can be expanded to any number of brands sold by the business for any date or unit price, which is why this function is considered very useful.

We can understand the VLOOKUP function in MS Excel by drawing a parallel with “Control F”, or the “find” function in MS Word. In MS Word, it is possible to use this function to go to the exact word, whereas using VLOOKUP; the user can get down to much more, like the entire object’s associated values.

Get professional help to understand VLOOKUP better

An exploration of this function is best made with expert help. At a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance; Excel expert David Ringstrom, CPA, will explain the way in which this program can be tweaked. David Ringstrom is a nationally recognized instructor who designs and teaches Excel courses that are based on over 25 years of consulting and teaching experience. To gain the benefit of experience that David brings into MS Excel, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501297LIVE?Wordpress-SEO

What makes this presentation different is that the presenter will demonstrate every technique at least twice: first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He will explain the differences in Excel 2013, 2010, or 2007 both during the presentation as well as in his detailed handouts. David will also give participants an Excel workbook that will include nearly all the examples he will be using during the webinar.

Alternatives to VLOOKUP do exist

However, using VLOOKUP isn’t always the most efficient approach. Hence, David will explain alternatives such as the INDEX and MATCH, SUMIF, SUMIFS, SUMPRODUCT, IFNA, and OFFSET functions. He will explain the limitations of VLOOKUP. In addition, he will also help participants understand the ways of future-proofing VLOOKUP by using Excel’s Table feature versus referencing static ranges.

One of the major gains of this learning session is that the participants will be able to improve the integrity of their spreadsheets with Excel’s VLOOKUP function. In addition to helping participants learn the ways of performing dual look-ups; the speaker will also help them get clarity on the user actions that can trigger #REF! errors. Participants will be able to use the IFERROR function to display something other than an #N/A error value when VLOOKUP can’t find a match.

He will cover the following areas at this webinar:

o  Future-proofing VLOOKUP by using Excel’s Table feature versus referencing static ranges

o  Using the SUMIF function to summarize data based on a single criterion

o  Learning why the INDEX and MATCH combination often is superior to VLOOKUP or HLOOKUP

o  Using the MATCH function to find the position of an item on a list

o  Using the IFERROR function to display something other than an #N/A error value when VLOOKUP can’t find a match

o  Improving the integrity of spreadsheets with Excel’s VLOOKUP function

o  Learning about the IFNA function available in Excel 2013 and later

o  Using the SUMIFS function to sum values based on multiple criteria

o  Using VLOOKUP to perform approximate matches

o  Seeing what types of user actions can trigger #REF errors

o  Performing dual lookups, which allow you to look across columns and down rows to cross-reference the data you need.