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.

Consider alternatives to AQL sampling plans

There are many alternatives to AQL sampling plans, but most companies are not aware of them to try to explore them. Acceptance Quality Limit, or AQL, is applied as a yardstick in most manufacturing organizations for assessing the quality of products they purchase. Its importance can be gauged from the fact that it is only after the Quality department is convinced about the product’s ability to meet AQL that the receipt is acknowledged and the payment made.

AQL

Understanding AQL

AQL, short for Acceptance Quality Limit, is the smallest, or worst, or lowest level of tolerable process means that can be accepted for the quality of product. It is the ratio or percentage level below which it is not possible to degrade quality to be termed acceptable.

Most medical device companies accept Acceptance Quality Level as a standard business practice and criteria for quality. The attribute sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans developed by Nicholas L. Squeglia are the most common applications used by companies.

Are there viable alternative to AQL sampling plans?

Yes, these two methods mentioned above are very commonly used, but it does not mean that they are the best. These methods are effective, but are not sufficient by themselves. Medical devices need to be aware of a variety of methods and when and how to use them.

The ISO 9001 and ISO 13485 require companies to establish “processes needed to demonstrate [product] conformity”. The FDA’s GMP (21CFR820) also requires that “sampling methods are adequate for their use”. An FDA guideline further states that “[a] manufacturer shall be prepared to demonstrate the statistical rationale for any sampling plan used”.

Sampling Methods

An AQL sampling plan does not provide everything that is needed to meet either or all of those requirements. Using only Attribute sampling based on ANSI/ASQ Z1.4 and Squeglia’s Zero Acceptance Number Sampling Plans, it is not possible to actually “demonstrate” that an AQL sampling plan ensures product quality.

This is where “Confidence/reliability” calculations come in as alternatives to AQL sampling plans. They are a more comprehensive and effective way of assessing the quality of purchased parts. Making calculations using tables and/or an electronic spreadsheet becomes easier. Using confidence/reliability calculations to provide evidence of product quality is also simplified through this method. The statistical rationale for such calculations is easy to explain and demonstrate, which is why these calculations are considered strong and reliable alternatives to AQL sampling plans.

Get to understand everything about the alternatives to AQL sampling plans

An understanding of these alternatives to AQL sampling plans 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. The speaker at this session is John N. Zorich, a senior consultant for the medical device manufacturing industry. To enroll for this highly useful webinar, please visit http://www.compliance4all.com/control/w_product/~product_id=501388LIVE?Wordpress-SEO

In-depth understanding of the alternatives to AQL sampling plans

John Zorich will explain the pros and cons of ANSI Z1.4, and Squeglia’s C=0 in detail. He will explain the areas in which these plans fall short of meeting regulatory requirements. He will offer real-world examples of how using such sampling plans leads to production of non-conforming product to augment the learning on the alternatives to AQL sampling plans.

The ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans, will be examined. As part of alternatives to AQL sampling plans, John will explain the advantages of “confidence/reliability” calculations. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is “Normally distributed”, the calculations are extremely simple. The speaker at this webinar will explain how “non-Normal” data need to be handled, and will providing the methods, formulas, and tools to handle such situations.

The webinar on alternatives to AQL sampling plans will conclude with a discussion of how one OEM manufacturer has implemented “confidence/reliability” calculations instead of AQL sampling plans for all of its clients. The speaker will offer suggestions for how to use “confidence/reliability” QC specifications instead of “AQL” QC specifications. The use of “reliability plotting” for assessing product reliability during R&D is also discussed.

The speaker will cover the following areas at this webinar:

  • AQL and LQL sampling plans
  • OC Curves
  • AOQL
  • ANSI Z1.4
  • Squeglia’s C=0
  • Confidence/Reliability calculations for
    • Attribute data
    • Normally-distributed variables data
    • Non-Normal data
  • Transformations to Normality
  • K-tables
  • Normal Probability Plot
  • Reliability Plotting.

Understanding the way the FDA works in handling food imports

The FDA’s task is cut out when it comes to one of its core functions –that of regulating imports. With the US economy absorbing food imports to the tune of $ 49 billion every year and with its allied regulatory agencies overseeing an astronomical number of nearly half a million facilities in the US and abroad; the FDA is certainly in a most unenviable position.

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In view of the fact that these foods are imported from almost all over the world to be sold into the US market; the FDA has strict regulations for ensuring the quality of the food items that enter the US market. Its primary task is to ensure that the foods and food products that enter the US market met the rigorous standards it sets in relation to safety, sanitation, wholesomeness and labeling.

Coordination with agencies across the country

Considering this fact, plus the fact that over two thirds of seafood and more than a third of all the food items consumed in the US are imported; it is no surprise that the FDA has a varied number of agencies with which it coordinates and whose help it takes to carry out its functions. These are some of them:

  • Homeland Security                              12662901_f520
  • Customs and Border Protection
  • The FDA and the USDA
  • Center for Disease Control
  • Food Safety Inspection Service
  • Agricultural and Marketing Services
  • Food and Nutrition Services
  • The U.S. Department of Commerce
  • Department of Defense, and
  • The Federal Trade Commission (FTC).

In-depth understanding of the FDA’s work on food imports

Want to explore how to understand these agencies work in tandem with the FDA and want to ensure that your products reach US shores without hassles and get regulatory approval from the FDA? Then, you need to attend 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 John Ryan, who began Ryan Systems a decade ago and who has been involved in the manufacturing, food, transportation and Internet industries over the past 30 years. To enroll for this webinar and gain the immensely sharp insights John brings into the FDA’s thinking on food imports, please visit

http://www.compliance4all.com/control/w_product/~product_id=501359LIVE?Wordpress-SEO

Complete understanding of the FDA’s work on food imports

John will offer understanding of the ways in which the various agencies work with the FDA in respect to food imports. A deep understanding in this area is necessary for those who want to import food to the US and gain regulatory approval for their products, since they all work with the FDA at various levels.

He will cover the following areas at this session:

  • Global Food Markets drive new import food safety requirements
  • Review how the FDA’s Food Safety and Modernization Act (FSMA) are changing things
  • Understand “Prior Notice” requirements
  • Foreign Supplier Verification Program (FSVP)
  • Prepare for the Foreign Facility Inspection Program
  • Learn what is in the “Investigations Operation Manual” (IOM)
  • What can happen to your product when seized
  • Learn what other countries require for food import
  • Review the proposed rules for food safety and quality during transportation processes
  • Learn how much food and what food is imported from different countries
  • Understand what the Imported Seafood Safety Program includes
  • PREDICT & OASIS Systems
  • Other resources available to help you.

How current regulations effect product development strategies

The life sciences market in Japan, consisting of pharmaceuticals, medical devices, biologics and combination products, is huge by the standards of the markets in the neighborhood, such as China, Malaysia, Singapore and Australia. It compares with those of Europe and North America. The main reasons attributed for this are the high spending power of the population, high number and density of the population, the aging population and the huge spending on the healthcare sector on R and D and innovation, which result in high costs that have to be passed on to the consumer.

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At this point of time, Japan is going through developments that have the potential to cause tremors, if not turbulence, in the life sciences market, particularly that of drugs. The annual potential for only drugs is pegged at ¥ 150 billion. In the backdrop of high unit prices of drugs, the government is keen to actively pursue a couple of major initiatives.

One, it wants to cut the price of generics, so that they reach out to a larger market base. Two, it wants to bring about improvements into the regulatory framework by focusing on regulations that ensure higher and easier postmarketing safety. The Japanese regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), is stepping up efforts to make changes into their IT systems, which will streamline the processes for filing clinical data for regulatory approval.

Makeover of its image

The PMDA also plans to recruit more manpower to tighten the overall regulatory process and bolster innovation in this sector to take it to even higher standards than it currently is in. the main purpose for which the PMDA is pushing for all these is to eradicate the impression that has gained ground, especially among western life sciences companies, that Japanese regulatory processes are laggardly and not up to the standards that can be expected from a country of its developmental level.

It is in the backdrop of these contexts that understanding what it takes to make regulatory filings in the life sciences in Japan acquires significance. An in-depth understanding of this topic will be the content of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Robert J. Russell, who is President of RJR Consulting, Inc., which assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance, will be the speaker.

To gain insights into how the regulatory filing requirements and compliance processes for Japan work, please enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501369LIVE?Wordpress-SEO

Insights into the regulatory scene

At this session, Robert J. Russell will familiarize participants with the regulatory compliance requirements and procedures for pharmaceuticals, medical devices, biologics and combination products in Japan. He will help participants get an understanding of topics relating to pre-clinical and clinical requirements, as well as with the structure of the regulatory agencies in Japan.

While elaborating on the current regulatory climate in Japan; the speaker will offer examples of effective compliance procedures and techniques. He will describe the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products and familiarize participants with a few common issues and concerns that professionals and firms dealing with Life Sciences usually face when they do business with Japan.

Japan’s utilization of the ICH standards

The speaker will also explain how Japan interacts with and utilizes ICH standards. He will also describe how Japan’s way of working with other national regulatory agencies influences their business. The webinar will show ways by which to address the conflicts that sometimes arise and suggest the optimal ways of doing this.

This course will provide insights into all the important areas of regulatory filing requirements and compliance processes for the life sciences in Japan. Its objectives are the following:

  • What is the Regulatory Structure in Japan
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
  • How to begin your company involvement in Japan
  • How current regulations effect product development strategies
  • Pricing issues
  • Understanding the concerns/issues of Japanese Regulatory Personnel
  • Understanding the Local Culture: How to negotiate with the regulators
  • Information necessary for effective submissions
  • Maintenance of Authorized Products

This is the outline for the course:

  • Japan’s Regulatory Structure for the Life Science Product Industries
  • Beginning Your Company Involvement in Japan
  • Life Science Regulations and the Regulatory Processes in Japan
  • Japan’s Use of ICH Standards/Principles
  • Marketing Authorization Processes – Filings & Registrations
  • Variations: Changes to Marketed Products
  • Renewals
  • The Do’s and Don’ts of Regulatory Involvement

Which Excel feature allows you to identify unlocked cells into which data can be entered

Mastering spreadsheet internal controls in MS Excel is a great way to make the most out of MS Excel. Unlocking these internal control features in MS Excel makes the program more efficient and powerful, and helps users derive more value out of its various applications.

Even though professionals in various areas, such as Accountants, CPA’s, CFO’s, Controllers, Excel users, Income Tax Preparers, Enrolled Agents, Financial Consultants, IT Professionals, auditors, human resource personnel, bookkeepers, marketers and government personnel, use MS Excel extensively in the course of their day-to-day work; they can still learn to improve and optimize the uses from MS Excel by learning more about it.

Learn the secrets of the power of MS Excel

This is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a highly interesting and educative webinar. This webinar will have David Ringstrom, an author and nationally recognized instructor who teaches scores of webinars each year, as speaker.

David’s Excel courses are based on over 25 years of consulting and teaching experience. He believes in the mantra: “either you work Excel, or it works you”. This is why he focuses on what he sees users don’t, but should, know about Microsoft Excel. His goal is to empower participants to use Excel more effectively.

It is this zeal the speaker carries into his teaching of MS Excel that will come into full play at this webinar. Interested in gaining from the wealth of experience that David brings into MS Excel? Then, just visit http://www.compliance4all.com/control/w_product/~product_id=501293LIVE?Wordpress-SEO to enroll.

Teaching from a simple standpoint

At this presentation, David Ringstrom will use a simple invoice form as a teaching aid to present various ways to control users’ actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. 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.

David will help participants with the following:

o  Discover how to use lookup formulas to find and access data automatically from lists

o  Apply Excel’s Table feature to future-proof elements of your spreadsheet.

o  Define how to use Excel’s Data Validation feature to restrict data entry to a list of permissible choices

o  Learn a custom shortcut for toggling the Locked status of a worksheet cell on or off

o  Understand how to preserve key formulas

o  Learn which Excel feature allows you to identify unlocked cells into which data can be entered

o  Learn a variety of ways to control users’ actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes.

David will cover the following areas at this webinar:

o  Using Conditional Formatting to identify unlocked cells into which data can be entered

o  Utilizing Data Validation to limit percentages entered in a cell to a specific range of values

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

o  Toggling the Locked status of a worksheet cell on or off by way of a custom shortcut

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

o  Preserving key formulas using hide and protect features

o  Making it harder for a user to circumvent data validation and easy for you to identify when someone has attempted to do so.

FDA holds Cosmetic Manufacturers & distributors responsible for the safety and quality of their Cosmetics

Testing cosmetics before the FDA does it is a sound business strategy for cosmetic manufacturers. This is why: Cosmetic manufacturers and distributors are responsible for upholding the quality and safety standards set out by the FDA. This is a legal requirement on the part of players in the cosmetics industry. In order to ensure compliance with its safety and quality standards; the FDA routinely carries out its own analysis of cosmetics.

The regulatory agency is all the more proactive in carrying out its quality and safety checks on products that carry potential problems. It comes down heavily on such manufacturers by alerting consumers about the problem product. It also carries out regulatory and enforcement actions against such products and companies.

Another reason for which cosmetic products need to be tested thoroughly for their quality and safety is that although the FDA does not require cosmetic products and ingredients, except color additives, to get approved by the FDA before they enter the market; it has laws on how these cosmetic products need to be regulated in interstate commerce. This makes it necessary to comply with the FDA’s standards on cosmetic safety and quality.

One of the lines of defense for such companies is to carry out testing of their product themselves before they start selling it in the market. This is a sound practice that helps companies in the cosmetic industry avoid punitive actions from the FDA.

Getting the testing practice right

But then, this practice has to be inculcated in the right manner, or it serves little purpose. The ways of implementing the right methods for testing the quality and safety standards of cosmetics before they are distributed into the market will be taught at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the speaker is Rachelle D’Souza, who, as CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities/agencies for multinational and start-up companies. The major learning Rachelle will offer at this webinar is the different ways by which to carry out practices that are prevalent in the cosmetic industry to help avoid enforcement actions from the FDA.

To gain knowledge of avoiding punitive actions from the FDA; please register for this webinar by visiting  Cosmetic Testing

Guidance on the FDA’s expectations

The important learning that this webinar will offer is that it will offer thorough guidance to cosmetic manufacturers and distributors, as also other entities such as color additive manufacturers and analytical and microbiological laboratories, on the recommendations and requirements that the FDA has with regard to the safety and quality testing of cosmetics.

In line with this topic, Rachelle will help participants explore important areas in this webinar, such as FDA considerations for microbiological testing, animal testing, potential contaminants, nanomaterials in cosmetics, cosmetic good manufacturing practices (GMP) compliance testing, shelf life/expiration dating, select cosmetic ingredients and color additive batch certification.

The content of this webinar is suited to act as a proper guidance to those involved in the various aspects of cosmetics, such as Cosmetic Manufacturers, Cosmetic Distributors, Cosmetic Ingredient Manufacturers, Color Additive Manufacturers, and Analytical and Microbiological Laboratories involved in Cosmetic/Cosmetic Ingredient Testing. They will benefit in a big way by learning about areas of FDA cosmetic regulations that Rachelle will explain at this session. She will cover the following areas at this webinar:

o  Microbiological Testing for cosmetics

o  Animal Testing & Cosmetics

o  Potential Contaminants

o  Color Additives & Batch Certification

o  Select Cosmetic Ingredients: Prohibited & Restricted Ingredients

o  Shelf Life/Expiration Dating

o  Nanomaterials in Cosmetics

o  Cosmetic Good Manufacturing Practices (GMP) Compliance Testing.

Understanding steam sterilization microbiology

Steam sterilization is an important means of killing microorganisms in microbiology. Sterilization is the method of removing all viable organisms from a source in a defined environment. Microorganisms are said to be dead when they are rendered ineffective by a decrease in their population in an environment. When they are unable to grow within their environment; they are considered dead. They don’t usually die the moment they are exposed to an agent that kills them.

Autoclaving is an important device used in steam sterilization microbiology. In addition to being used for sterilizing many devices such as surgical instruments, laboratory items and many more; an autoclave is also used in microbiology to sterilize microorganisms that cannot be killed by normal methods such as boiling and the use of strong detergents.

Autoclave qualification

The methods of steam sterilization microbiology need to be understood thoroughly, since they need to comply with regulatory requirements. An autoclave needs to be qualified for its performance, the basis for which is a proper grasp of stream sterilization microbiology.

Sterilization process parameters need to be laid out as a basis for conducting autoclave performance qualification studies. Exact standards of steam sterilization need to be met, whether it is to qualify a new autoclave installation or to continue maintenance of existing equipment.

A learning session on these methods

The ways of doing this will be the learning 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 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. To understand the way by which your steam sterilization microbiology needs to meet regulatory compliance standards; please enroll for this webinar by visiting Steam Sterilization Microbiology

A full description of steam sterilization microbiology

Since successful autoclave Performance Qualification depends on a thorough grasp of steam sterilization microbiology; Danielle will describe the steam sterilization mechanism as it relates to bacterial cells and endospores. She will explain the process and key terminology, because understanding these fundamentals is critical to develop a successful autoclave sterilization process.

She will offer regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators. She will also explain definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Quality Assurance Managers, Supervisors, Validation personnel and Sterility Assurance personnel will find this course useful. It is to meet the following objectives that this webinar is being organized:

o  Steam sterilization on a microbial level

o  Autoclave Performance Qualification expectations

o  Regulatory and GMP requirements for steam sterilization

o  Process verification tools for use in an autoclave Common questions, problems and cGMPs.

Danielle will cover the following areas at this webinar:

o  Autoclave Performance Qualification expectations

o  Regulatory and GMP requirements for steam sterilization

o  Validation tools for use in an autoclave

o  Common questions, problems and cGMPs.