Sources of contamination that exist in a clean room environment

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.

The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for injections that are administered to patients. Aseptic technique is suited for application in any clinical setting. Infections can be caused when pathogens come into contact with the patient through a number of sources such as equipment, the environment, or the personnel in the cleanroom.

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The fact is that any patient is potentially vulnerable to infection. Further, certain conditions such as injuries caused by accident, immune disorders that upset the body’s natural defenses and extensive burns increase the susceptibility of the patient to greater levels of infection. Surgery, urinary catheters, drains and the insertion of intravenous lines are common situations that require the use of aseptic technique.

A learning session on all the areas of aseptic techniques

All the core aspects of aseptic techniques and the ways of applying them in a cleanroom environment will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this webinar is Danielle DeLucy, who owns ASA Training and Consulting, LLC, which provides pharmaceutical and biologics-based companies with training and Quality Systems assistance that helps them meet regulatory compliance.

Please enroll for this webinar by visiting Aseptic Technique and Cleanroom Behavior

Why are cleanrooms built the way they are?

This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a cleanroom environment. It serves as a good refresher for those personnel that are familiar with the way to properly work in the cleanroom. Danielle will explain the rationale behind designing cleanrooms the way they are and how this design helps in ensuring proper contamination control. She will review some of the proper methods of contamination control, such as cleaning and gowning.

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At this webinar, which is of high value to those involved in contamination control, such as aseptic operators, aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC) and their management and Quality Assurance counterparts; Danielle will impart the following learning objectives:

  • Definition of Aseptic Processing (AP)
  • Terminal Sterilization vs. AP
  • Proper Personnel Behavior in a Cleanroom
  • Facility Design and how it impacts the product
  • A review of proper environmental monitoring practices and systems used
  • Aseptic Technique &clean room behavior.

Why is credit card surcharge an issue for businesses?

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even as State laws will continue to override networks merchant rules; companies have been looking out for ways to skirt the laws.

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The credit card surcharging issue in the US

Why is credit card surcharge an issue for businesses? It is because the credit card surcharge is the last link in the payment chain and causes a business that makes use of this facility to incur expenses. In simple terms, this is the checkout fee that gets added to every consumer’s shopping bill whenever a credit card is used to make payments for the purchases made at the business. Businesses are not willing to bear this expense and like to pass it on to the consumer.

The court judgment of 2012 permitted charging of credit card surcharge for certain card transactions from January 2013. As a result, there has been a change in not only merchant processing transactions but also of credit card usage. The settlement makes it mandatory for businesses that levy the credit card surcharge to follow requirements relating to consumer disclosure and to set limits on the amounts for which the surcharge is collected.

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They should also notify Visa and their acquirer of their decision to charge credit card surcharge a month before they begin to levy the surcharge. These rules vary from State to State, and the business is free to choose which brands of its outlet it wants to keep the credit card surcharge.

Clear the confusions about the issue

A more detailed and clear understanding of this topic will be offered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Ray Graber, a highly experienced professional in the payment industry, who brings deep and profound understanding of the way banking and finance converge with technology, will be the speaker at this webinar.

Please register for this webinar by visiting What are the Stipulations for Compliance

Clarifying the important issues relating to credit card surcharging

Ray Graber will offer clarity on the changes in the rules and will explain who benefits from the changes, and how these changes are going to affect the retailers and customers. He will explain the perils of an uninformed reaction to surcharging by end-user organizations. He will show why it is important to first look at the big picture of credit card surcharging, since end-users should also educate suppliers about the economics of card acceptance, pointing out the savings possible and other benefits. Suppliers should not be adding a surcharge when they are reaping the rewards. Ray will explain how they might overlook the benefits of card acceptance, as well as the cost of other payment methods like checks and cash.

Being of high value and importance to every level of employee who works in the credit card industry, such as financial officers, small business owners, corporate risk officers, internal auditors, operational risk managers, credit card program administrators, CPA’s and attorneys and legal staff; this session will cover the following areas:

  • What changed in the rules?
  • Why did it change?
  • What rules apply to surcharge?
  • Survey results
  • Who may benefit?
  • Will this change anything?

Steps to IEC 60601-1 approval

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.

The IEC 60601-1 is going through its latest revision, its 3rd edition, which came into effect in June 2012. The regulatory agencies of various countries that have adapted this standard are in various stages of implementation. Documentation and certification for IEC 60601-1 is to be done in stages at various dates, which will go up to 2018.

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Major product safety changes brought about by the 3rd edition

Through the publication of Amendment I, IEC 60601-1 brings in around 20 new requirements and some 60 modifications to the existing requirements. The major change IEC 60601-1’s latest version, 3.1 of the 3rd edition brings is that it makes a risk management file and process that aligns with ISO 14971 mandatory for manufacturers of medical electrical equipment. The ISO 14971 is the global standard that applies to risk management in medical devices.

The IEC 60601-1 3.1 Edition also requires design review and third party approval for medical devices. In addition, this version has also modified requirements in relation to these among many other areas:

  • Essential Performance
  • Documentation
  • Humidity
  • Marking and Labeling
  • Temperature Testing
  • Programmable Electrical Medical Systems (PEMS)
  • Mechanical Hazards
  • Electrical Hazards
  • Construction

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Stay clear of the complexity

Want to understand the ways by which the new IEC 60601-1 version works for your organization? Want to clear the confusions regarding implementation of the new IEC 60601-1 standard and gain acceptance by meeting compliance requirements set out by the various regulatory agencies? A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance will provide all the answers.

The guru of IEC 60601-1, Leonard Eisner, will be the speaker at this highly insightful session. The Founder and Principal Consultant at Eisner Safety Consultants, which specializes in helping medical device manufacturers through product safety, international regulatory (FDA 510(k), CE Mark, Canadian Medical Device Regulations (CMDR), etc.) and quality system processes; Leo, a licensed professional engineer in safety engineering, a Notified Body and Quality System auditor/technical reviewer, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives, has helped countless clients through the Product Safety and Regulatory maze over his career.

To register for this highly interesting and relevant session, please visit 16 Steps to Get Approval to IEC 60601-1

Learning from others’ mistakes

Leo will help participants accelerate their time to market. He will show how to follow the steps and hasten the speed at which they can obtain their product certification to IEC 60601-1 series of standards. All the expectations for product testing set out by certification agencies to the IEC 60601-1 series of standards on medical electrical equipment and systems, such as UL, TUV, BSI, Intertek, etc., will be explained.

An important element of the learning at this webinar is the ways by which to learn from the mistakes Leo has seen others make that have gone on to slow their certification process. He will show the participants what proactive steps they can take to avoid these mistakes and ensure that their product doesn’t need to get redesigned after testing starts.

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Leo will cover the following areas at this webinar:

  • Learn about the scope of the IEC 60601-1 standard & if it applies to your product. Also, what are the Collateral Standards (IEC 60601-1-X) and Particular Standards are about
  • What you need to know to classify your products to the IEC 60601-1 series
  • What is an isolation diagram and how does that help me with my design?
  • Determine the applicable tests for your device
  • What are the marking and labeling requirements for the device?
  • Know your critical components
  • What pre-tests to run and what’s not worth pre-testing?

How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious problems and costs for your company.

risk-management-definitionIn this webinar we’ll cover:

  • Overview and Definitions
  • FDA Expectations
  • ISO14971 Regulation
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle
  • Common mistakes
  • Best Practices

Why should you have to Attend The cost of poor product risk management can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers can all result from poor risk management. And these types of problems expose you to regulatory inspections and citations. Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle.

These are the areas covered by the speaker Susanne Manz

  • Overview of the ISO14971 standard as it applies to medical device companies
  • Integrating the new standard with ISO 13485 as part of your overall QMS
  • Conducting a review of the intended use of your device
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Judging the probability that harm may occur from those hazards
  • How to control those risks and monitor the effectiveness of the controls put in place

By login with this Risk Management Techniques for Medical Devices

Which are the experts benefited by this session are as shown in the below

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  • Design Engineer
  • Manufacturing Engineer
  • Quality Engineer
  • R&D Personnel
  • R&D Project Managers
  • Quality Managers
  • Auditors
  • Regulatory Affairs Specialist
  • R&D Manager

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide

Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.

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Why should you attend your staff should understand Letters of Credit. Even in today’s free trade-oriented business environment, companies must exercise particular caution when agreeing on payment terms. With financing choices that include cash in advance, open terms, letters of credit (L/C), sight drafts and time drafts, both importers and exporters need to understand the true implications of their credit policies and practices. By login with this Letters of Credit for Importers you may know.

These Things of the areas will be covered by the speaker Douglas Cohen

  • Gain a Comprehensive Understanding of the Letter of Credit Process
  • Learn how to Negotiate the Terms of both Import and Export L/Cs
  • Be 100% aware of Letter of Credit Documentation requirements
  • Be Aware of all Expenses Associated with Using Letters of Credit
  • Learn how to Avoid Amendments and Discrepancies

Understand the role of banks and freight forwarders in the L/C process.

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  • Documentary Credits Defined
  • Letters of Credit for Exporters
  • Sight Drafts and Time Drafts
  • Documentation Requirements
  • Letters of Credit for Importers
  • The Letter of Credit Process
  • Amendments and Discrepancies

Those who are the experts benefited by this

  • Exporters
  • Logistics and Trade Professionals
  • International Sales Executives
  • Customs Brokers
  • Freight Forwarders
  • Airlines
  • Steamship Lines
  • International Banking Personnel
  • Professors and Students of Global Trade

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Douglas Cohen has been at the forefront of international trade and transactions. With positions in private law practice, US Department of Commerce, the European Union, IATA, and American Airlines, he has developed significant expertise in import-export operations and compliance, global transactions, international negotiations, intellectual property, and cross-cultural business communication. At present, Mr. Cohen is Senior Manager, Global Trade and Contracts at Worldwide Trade and Legal Associates (WWTL), where he provides legal and strategic advice to organizations seeking to enter or expand foreign markets.

In addition, he is the director of WWTL’s Global Trade Compliance Training division, where he offers comprehensive import-export training to private companies, universities, and pubic organizations.

Mr Cohen has been asked to teach university courses and corporate seminars on international business and law in the US, Europe, Asia, and the Middle East. He is the author of numerous publications on Internet law, international contract negotiations, intellectual property protection, and import-export operations and compliance.

How to deal with dynamic source data and the “refresh” concept

Microsoft Excel comes with a myriad of tools such as sorting, filtering, and subtotal to manage large lists of data. Yet, when it comes to analyzing all that data and doing it quickly, the MS Excel PivotTable is a very useful feature. It is particularly important and useful when the user is required to quickly create a compact summary report (based on lots of data) without needing to write complex formulas or rely on lengthy techniques.

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MS Excel PivotTable is very versatile. It is considered Excel’s best analytical tool because in addition to speed, it also comes with amazing flexibility and dynamism the data interrelationships that are being viewed can be changed. It is easier to put the PivotTable MS Excel features into practical use by actually getting down to work on it, rather than trying to pore through the instructions on the printed page, which is a visually-oriented feature based on displaying fields in different locations. It offers the ability to create a complete summary report with heaps of data in very little time without having to write complex formulas and rely on obscure techniques.

Learn about all the features and aspects of PivotTable from the MS expert

A complete learning on the numerous PivotTable capabilities and its many tools and features will be offered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

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Dennis Taylor, an Excel expert who has worked extensively with Microsoft products (especially spreadsheet programs) since the mid-1990’s and has taught hundreds of workshops and authored numerous works on this program; will be the speaker at this session. Just visit Excel PivotTables to register for this webinar and gain complete insights into the ways by which to put the full array of functionalities of MS Excel PivotTable.

Simplifying the use of PivotTable

The main objective that Dennis Taylor has for this webinar is to familiarize participants with the quickest and best ways to create PivotTables and Pivot Charts. These include the following capabilities:

  • How to compare two or more fields in a variety of layout styles
  • How to sort and filter results
  • How to perform ad-hoc grouping of information
  • How to use Slicers instead of filters to identify which field elements are displayed
  • How to drill down to see the details behind the summary
  • How to categorize date/time data in multiple levels
  • How to create a Pivot Chart that is in sync with a PivotTable
  • How to add calculated fields to perform additional analysis
  • How to hide/reveal detail/summary information with a simple click
  • How to create a PivotTable based on data from multiple worksheets.

He will cover these in detail. In addition, he will cover the following areas at this session on MS Excel PivotTable:

  • Pre-requisites for source data – preparing data so that it can be analyzed by PivotTables
  • Creating a PivotTable with a minimum number of steps, including the Recommended PivotTables option
  • Manipulating the appearance of a PivotTable via dragging and command techniques
  • Using Slicers to accentuate fields currently being shown (and which ones are not)
  • Using the new (in Excel 2013) Timeline feature
  • Creating ad hoc and date-based groupings within a PivotTable
  • Quickly create and manipulate a Pivot Chart to accompany a PivotTable

MS Excel users who are familiar with PivotTable concepts, but need expanded techniques to analyze lists of data are among the primary beneficiaries of this webinar, but anyone needing to know how to create PivotTables from multiple sources and use Slicers, Timelines, Calculated Fields, and Conditional Formatting will also benefit from this course.