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.

Learn how to build professional, eye-catching form-driven applications and spreadsheets

MS Excel, a wonder program, has umpteen uses for a number of professionals, students, and a host of other users. We have known for long that it can be used to carry out a number of functions that are varied and interesting. However, adding design elements to MS Excel goes a long way in enhancing its aesthetic appeal, as also the effectiveness.

Booking forms, sales order forms, invoices, loan agreement forms and surveys are just some of the endless kinds of forms that can be created using Excel. These can be made a lot more attractive and likeable by just adding a touch of features such as color, cell protection and some drop-down lists and simple validation.

A few simple steps at design

Just a few splashes here and there into these forms, and you will be amazed at the extent to which these bland forms can transform themselves into user-friendly ones that will make data entry simple and error free for everyone concerned, be it the user, her colleagues, or her clients. Small techniques such as this will eliminate the hassle of having to go through the long-winded, repetitive and frustrating experience of entering and editing data into a table in Excel.

This is just one of the many tricks that will be taught at a webinar on adding design elements into MS Excel to make it more illustrative, attractive and useful. At this webinar, the Expert, Mike Thomas, the globally acclaimed guru of MS Office, who has spent over a quarter of a century as a subject matter expert in a swathe of subjects relating to MS Office and Mac, will be the speaker.

Loads of experience

The experience and wisdom that Mike has gained over these years, during which he has been Fellow of The Learning and Performance Institute and has worked with and for a large number of global and UK-based companies and organizations across a diverse range of sectors, will be in full flow at this highly interactive webinar session. Want to know how to optimize the use of design elements into MS Excel to make it more palatable and likeable? Just log on to http://www.compliance4all.com/control/w_product/~product_id=501316LIVE?Wordpress-SEO to enroll and relive the fun of learning about MS Excel.

Adding design elements into MS Excel to save costs and time

The main benefit that people across a spectrum of professions and activities, such as Business Professionals, Business Owners, Researchers, Administration Support Staff Educators, or for that matter anyone who wants to learn how to get the best from MS Excel to manage projects and their life, will gain from this webinar is that they can save the invaluable resources of time and money by learning to enhance the use of forms in MS Excel.

This session is highly useful to smaller organizations that are constrained with limited budgets and will think twice when needed to buy expensive dedicated software to manage the inputting and storage of information. This of course, does not preclude bigger companies from this learning.

Using other MS Excel features to create forms

The speaker will enable participants to follow real-world examples to learn how to build professional, eye-catching form-driven applications and spreadsheets. Since there is no option for creating a form; Mike Thomas will teach participants how to use a number of other built-in MS Excel features to create forms and then subsequently make them attractive with its design.

Mike will cover the following areas at this webinar:

o  Naming cells-to make formulas easier to understand

o  Drop-down menus and checkboxes-to make data entry easy

o  Data validation and protection-to reduce the risk of data-entry errors

o  Formatting-to make your forms inviting to use

o  Formulas and functions as VLOOKUP

o  Simple automation.

An effective internal audit program is indispensable for continuous improvement

Both the ISO and the FDA require an internal audit program of an organization’s Quality Management Systems. This is a core requirement. The simplest way to understand an internal audit system is that it is a tool to assess or inspect an organization’s Quality System.

Apart from helping organizations to fulfill the requirements of auditing set out by the ISO and the FDA and other regulatory bodies, audits, be they internal or external; carry manifold advantages. These are some of them:

o  Organizations can apply best practices relevant to their industry through audits

o  Audits help organizations to identify where they need to improve

o  Audits play a stellar role in ensuring the quality of products, which leads to enhance customer satisfaction

o  They help organizations to take preventive actions with which bigger problems can be checked

Most organizations think of audits as an unpleasant duty

Although internal and external audits are considered so useful; it is a fact that most organizations carry them out only because it is thrust upon them. Most companies lack the conviction and volition for an audit, and drag their feet when it comes to this important task. The many benefits of an audit program are usually overlooked by 75% of companies.

What happens to organizations that are not diligent when it comes to carrying out audits? They are sure to receive penal actions from the FDA, which range from Warning Letters, 483’s to penalties to Consent Decree.

Learning session on ways of getting internal audits right

In order to help organizations get their internal and external audits right, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. The purpose of this session is to help professionals who need to carry out an internal audit for their organization, get it right.

The speaker at this seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., who is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. Participants that want to get a clear and total understanding of the rationale for carrying out audits and of the ways for get them right can enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501303LIVE?Wordpress-SEO

An explanation of the ins and outs of auditing

Susanne will equip participants with the knowledge needed for audit professionals in organizations to put an effective and compliant audit program in place. She will help them understand what it takes to carry out a solid and thorough quality audit program that meets regulatory requirements by first being able to identify the red flags. This is the groundwork for understanding, reducing and communicating risks associated with quality and compliance.

Susanne will cover the following areas at this session:

o  Using a structured program to identify areas of risk leading to an effective audit strategy

o  How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review

o  How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues

o  How a culture of quality and compliance can encourage clear and transparent communication of risk

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time

o  How to identify residual risk

o  Monitoring and Controlling progress over time

o  Signs that your company culture is taking unnecessary compliance or quality risk

o  How to ensure management gets valuable information from your audit program

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time.

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.

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.