Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.

The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as part of a manufacturer’s Quality Management System.

ISO 13485 primarily identifies and traces cleanliness in the area of work environment and helps to manage risks. Although it does not require alignment with 21 CFR Part 820 and other FDA QSR regulations; the two complement each other.

Flexibility individualizes Quality Systems

Despite the assignment of specific tasks from each of these standards for establishing Quality Systems; there is an element of flexibility, because what precisely determines a Quality System varies from one firm to another, based on its values, mission and culture. In these cases, what medical device and pharmaceutical companies are required to do is to define and frame their own Quality Systems and then link them back to appropriate FDA definitions.

This is of critical importance, because when an individual Quality System is framed uniquely for an organization and is not aligned to the respective FDA definition; it makes the company’s regulatory inspections preparedness difficult and laden with impediments. This is one of the fundamental aspects of compliance with FDA regulations.

Professional learning on implementing the right Quality Systems

How do medical devices or pharmaceutical companies build Quality Systems that are effective and are traceable to relevant FDA regulations? The ways of doing this will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Louis Angelucci, who is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation, will be the speaker at this webinar.

Want to gain complete knowledge of how to build Quality Systems that tie with relevant FDA definitions? Want to make sure that your Quality Systems pass FDA regulatory compliance requirements and do not invite penal actions from the regulatory body? Then, register for this learning session by visiting http://www.compliance4all.com/control/w_product/~product_id=501189?Wordpress-SEO

An explanation of regulatory requirements

During the course of this webinar, Louis will offer participants a perspective of the expectations of a Quality System as they apply to validation. He will also explain the requirements of regulations for the pharmaceutical and medical device industries.

At this webinar on Quality Systems, which will hugely benefit professionals such as QA specialists, Quality Systems Specialist, Managers and Operators, Louis will cover the following areas:

o  Regulatory expectation regarding Quality Systems

o  How to establish Quality Systems

o  Quality systems fundamental

o  FDA definitions

o  Fitting within the FDA puzzle

o  How to maintain and operate within a quality environment.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/

http://qualitymanagementsystem.com/iso-13485-saving-lives-through-quality-management/

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?

This is simply not the case. Quality and compliance are built into a medical device product. It is only that companies need to have the capabilities needed for meeting Quality and compliance requirements from a regulatory perspective. If medical device companies have to be successful in their endeavors in the future, they have to be adept at how to meet quality and compliance requirements set out by the FDA.

Quality and compliance to meet regulatory requirements

Why is this needed? Simple: If medical device companies do not meet regulatory requirements set out by the FDA; they are not likely to meet the quality requirements demanded of their products. As a result, apart from being unable to create products that appeal to customers, they could end up facing punitive actions from the FDA.

As said, meeting Quality and regulatory compliance requirements is not something of a gamble. Quality and compliance, which are the key inputs for meeting customer demands, can be fulfilled by putting a thorough process in place. These are capabilities a medical device company needs to have if it has to meet quality and compliance requirements and succeed in the market.

Learn the ways of meeting Quality and regulatory requirements from the expert

The method by which medical device companies can achieve regulatory compliance requirements and ward off punitive actions from the FDA will be taught at a very interesting and lively webinar from Compliance4All.

The speaker of this webinar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will demonstrate just what medical device companies need to do in order to meet Quality and regulatory compliance.

To gain complete insights into how medical device companies can take the requisite steps needed for meeting quality and compliance requirements, please enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501160?Wordpress-SEO

An explanation of the seven capabilities needed for meeting quality and compliance requirements

At this session, Susanne Manz will explain that there are seven capabilities that are needed for medical device companies to accomplish their aim of meeting Quality and regulatory compliance requirements. She will explain these and offer complete understanding of how the changing regulatory climate needs to be comprehended. She will show how to evaluate one’s capabilities to develop a regulatory strategy that will help companies meet their requirements, so that they become successful in the pursuit of their objectives.

Susanne will show how to develop strategy from one’s self-awareness of the Quality and regulatory requirements. At this webinar, she will cover the following areas:

o  Evolving Regulatory Climate

o  Seven Key Capabilities for Success

o  How to evaluate and map your capabilities

o  Quality Planning and Improvement

o  Maturity Modeling

o  Developing Your Quality and Compliance Strategy.

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither practicable nor useful.

Examples of process changes that SPC helps to detect include trends, shifts and variation. Three items are needed for SPC to meet its goal:

o  A system that measures effectiveness in real-time

o  Tolerance that is practical and is connected to customer keenness and satisfaction

o  A dial indicator that comes with an anticipated response.

All these help SPC to determine whether a process is stable and requires no adjustment, is incapable of performing its functions altogether, or is deviating but capable.

And now, pre-control

Pre-control, on the other hand, inspects the units and adjusts the process and the succeeding sampling procedures assuming where the measurements are placed in relation to the specification limits. The focus of pre-control is individual measurements.

It uses a set of probabilities, based on assumed distributions and the location of the process, to estimate where there is a justification for the process adjustments. Since decisions concerning pre-control are based broadly, i.e., on the area in which the measurements; it obviates the need for charting, as it is very responsive to the process signals right from the start.

SPC or pre-control?

There are arguments for and against the use of SPC and pre-control as an effective means of ensuring that the process is right and that it results in the desired quality for the product.

At a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, the speaker, Jd Marhevko, who has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries for more than 25 years, will explain all the aspects of pre-control. To hear her perspective of pre-control, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501074?Linkedin-SEO

What makes this webinar special is that it has consistently ranked in the top 1-5% at previous conferences at more than five venues. It was featured in ASQ QMD’s special edition of the Quality Management Forum’s 2015 Spring edition (ASQ-QM.org). A webinar of this topic was provided in 2015 via the ASQ QMD Linkage Technical Committee to over 1300 respondents through the IMA and ASQ QMD.

Tools needed for pre-control

At this hour-long session, Jd will explain all the elements of pre-control in Quality. she will show to participants the way of drafting and creating a pre-control chart. She will run a process in which to model the next steps and decisions.

The aim of this session is to equip participants with the knowledge needed for reducing the complexity of the system and bringing about an improvement in the effectiveness and efficiency of their Quality Management Systems.

A session packed with interaction and practical application of principles

A major component of this webinar on SPC and pre-control is that Jd will share the result of case studies. The knowledge gained at this webinar can be applied immediately at their work in respect to the following:

–       Measurement System Analysis (MSA): Jd will conduct a high level overview of MSA. This will help the participants get a grasp of the need for putting an effective measuring system in place ahead of implementing pre-control

–       Cpk Overview: To help participants gain baseline capability in advance of implementation of pre-control, a high level Cpk overview will be conducted

–       Normal Distribution: The way in which the cumulative distribution function of the normal distribution is to be used for estimating and establishing the zones on a pre-control chart

–       Pre-Control Chart: Jd will show participants how to apply the concepts listed above with the use of a mock pre-control chart where the process will be demonstrated based on the “go/no go” zones that are established.

At this webinar, Jd will cover the following areas of pre-control:

o  Reduce process complexity and minimize risk

o  Increase affectivity of a Core Tool

o  Increase personnel compliance in proactive process management.

https://www.isixsigma.com/tools-templates/control-charts/using-control-charts-or-pre-control-charts/

http://www.symphonytech.com/articles/pdfs/precontrol.pdf

http://www.winspc.com/what-is-spc/ask-the-expert/400-pre-control-no-substitute-for-statistical-process-control

http://www.qualitymag.com/articles/86794-pre-control-may-be-the-solution

A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.

The 21st Century Cures Act aims at strengthening funding for the National Institutes of Health (NIH) by allocating over $ six billion to them. Of this, nearly $ five billion will go towards biomedical research funding. One of the highlights of the 21st Century Cures Act is the allocation of nearly $ two billion for the “Beau Biden Cancer Moonshot” initiative, which is in honor of the Vice President Joe Biden’s son, who succumbed to brain tumor.

A different take on health improvement

This approach is a significant one, considering that researchers from some of the nation’s best-known science universities depend on NIH funding for their research. Nearly two thirds of the major drugs that are in the market since 2000 have been the result of NIH research.

In addition, the 21st Century Cures Act will also have a major impact on mental health. This is one of the most notable features of this Act. It allocates over a billion dollars for addressing opioid and other addictions in the US, and the health-related complications that arise from them, which is a significant contributor to the fall in national health standards and productivity of the population in its prime.

Will the 21st Century Cures Act change the FDA approval process?

While addressing this core aspect of scientific research in helping to treat chronic diseases; the 21st Century Cures Act also focuses on another very critical point of medicines: The FDA. Since no drug can ever enter the market without FDA approval and the FDA approval process is very lengthy, expensive and cumbersome; the 21st Century Cures Act seeks to address this fundamental issue by suggesting changes into the approval process for new drugs, as well as medical devices.

Concerns and criticisms

Reservations have been expressed about the effectiveness of the 21st Century Cures Act. The main concern is that the regulatory approval process of drugs from the FDA could get diluted, causing a risk to the lives of the patients, thereby reducing the ability of the FDA to protect lives with its regulations.

There are many issues at stake in this highly important legislation. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will discuss the prospects and downsides of this very important law.

At this webinar, John E. Lincoln, a very experienced medical device and regulatory affairs consultant, will offer a complete insight into the provisions of the 21st Century Cures Act. This webinar will be highly meaningful and useful for research institutions and organizations that are directly concerned and connected with the FDA and its administration of emerging technologies and general health. Enroll for this webinar by registering at http://www.compliance4all.com/control/w_product/~product_id=501213?Worpress-SEO

Analysis of all the major aspects of the 21st Century Cures Act

John will explain and analyze all the main areas of the 21st Century Cures Act. He will scrutinize how the Act will concern the FDA, the impact it will have on other areas of the Federal government, and the possible benefits and drawbacks for industries and research institutions that will get directly and indirectly affected by the Act, and the general public.

John will cover the following areas at this webinar:

  • The Act’s 3 Main Areas
  • Increased Funding for Medical Research
  • Speed the Development and Approval of Experimental Treatments
  • Overhaul Federal Policy on Mental Health Care
  • Stated Advantages
  • Concerns Expressed
  • What Has Happened So Far

http://www.foxnews.com/health/2017/01/24/how-21st-century-cures-act-will-save-lives-through-research.html

Lyophilization: Validation and regulatory approaches

Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.

Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.

Lyophilization is considered complex

Parenteral products such as anti-infective drugs, many biotechnological products and in-vitro diagnostic products are some of the areas in which lyophilization is used. However, no matter for which field lyophilization is used, it is considered rather tough.

This is mainly because the process of obtaining the product from the lyophilization process is rather complex. It has to be carried out through a number of minute and delicate processes. Complex technology goes into the entire process.

Solution formulation, filling up vials and the validation of this process, sterilization, engineering, and the act of scaling up of the lyophilization cycle and its validation are some of the issues that make lyophilization difficult. Moreover, the processing and handling time needed for lyophilization is pretty high, as is the cost and complexity of the machinery and equipment needed for lyophilization.

Regulatory issues as well

On top of all these, the process of lyophilization has to be compliant with FDA compliance requirements. This adds to the complexity of lyophilization. However, despite these difficulties associated in many ways, lyophilization is a process that cannot be done away with, since it has tangible benefits for parenteral products.

Is there a way out of this difficulty? Should the complexity associated with lyophilization put manufacturers off? No. A webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will suggest ways of simplifying lyophilization while meeting the required regulatory expectations.

Simplified learning about the complex art of lyophilization

At this webinar, the speaker, John Godshalk, will seek to simplify the science of lyophilization. Currently a Senior Consultant at the Biologics Consulting Group; John brings the many years of his experience in the regulatory areas into this webinar. To make lyophilization simpler and to derive the benefit of this teaching, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501111?Wordpress-SEO

Understanding the FDA’s line of thinking

At this session on lyophilization, which will be highly useful for professionals such as Compliance Managers, Process Engineers, Validation Managers, Validation Engineers and Regulatory Managers; John will explain the way the FDA thinks when it comes to inspection and regulation of the lyophilization process, equipment, and controls.

The speaker will offer insights into what the FDA and other regulatory bodies consider as important while inspecting lyophilizers, and in the validation process. He will devote a major portion of the presentation to the regulatory aspects of lyophilization.

While explaining the science and art of developing lyophilization cycles and the way in which lyophilizers work and are controlled; John will take up other important areas of lyophilization, such as lyophilization controls, of which computer controls and validation are a part, and quality-related aspects of lyophilization, such as how to obtain a resulting quality product.

During the course of the presentation, the speaker will cover the following areas:

o  Science of Lyophilization

o  Cycle development and tools

o  Validation of the Lyo Cycle

o  Lyo equipment validation

o  Regulatory requirements

o  How the lyo process and equipment are inspected

o  The science and the art

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074909.htm

Understanding normality tests and normality transformations

That the inputted data should be “normally distributed” is a requirement of the calculations used in many statistical tests and methods. Typically, the methods used for Student’s t-Tests, ANOVA tables, F-tests, Normal Tolerance limits, and Process Capability Indices include such calculations.

A core criterion for ensuring the correct results is the one that the raw data used in such calculations be “normally distributed”. It is in view of this fact that the assurance that the FDA holds a company’s “valid statistical techniques” being “suitable for their intended use” as a critical component for making the assessment of whether or not data is “normally distributed”.

Now, which are the types of data that are normally distributed? Dimensional data, such as length, height and width are considered as being typically normally distributed. Which kinds of data are usually non-normal? The typical example of non-normal data are burst pressure, tensile strength, and time or cycles to failure. Some non-normal data can be transformed or converted into normality data for the purpose of validating statistical calculations, when they are run on the transformed data.

 

Get an understanding of the normally distributed and normality transformation data

Statistics professionals can get a thorough understanding of the concepts of what are normally distributed and how to transform non-normal data into normality at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance. At this webinar, John N. Zorich, a senior consultant for the medical device manufacturing industry, will be the Speaker. To register, please visit

http://www.compliance4all.com/control/w_product/~product_id=501103?Wordpress-SEO

John will take the participants of this webinar through all the aspects of “normally distributed” data and how to transform non-normal data. He will explain the various elements of data, such as:

o  What it means to be “normally distributed”

o  How to assess normality

o  How to test for normality

o  How to transform non-normal data into normal data

o  How to justify the transformations to internal and external quality system auditors.

A combination of graphical and numerical methods that have been in use for many years constitute Normality Tests and normality transformations. These methods are essential whenever one has to apply a statistical test or method whose fundamental assumption is that the inputted data is normally distributed. John will offer an explanation of these methods.

What goes into normality testing and normality transformation?

While normality “testing” involves creating a “normal probability plot” and calculating simple statistics for comparison to critical values in published tables; making simple changes to each of the raw-data values, such that the resulting values are more normally distributed than the original raw data, is what a normality “transformation” involves.

Professionals whose work involves normality testing, such as QA/QC Supervisor, Process Engineers, Manufacturing Engineers, QC/QC Technicians, Manufacturing Technicians, and R&D Engineers will find this session very helpful. John will offer guidance on both objective and some subjective decision-making that go into the evaluation of the results of “tests” and “transformations”.

John will cover the following areas at this webinar:

o  Regulatory requirements

o  Binomial distribution

o  Historical origin of the Normal distribution

o  Normal distribution formula, histogram, and curve

o  Validity of Normality transformations

o  Necessity for transformation to Normality

o  How to use Normality transformations

o  Normal Probability Plot

o  How to evaluate Normality of raw data and transformed data

o  Significance tests for Normality

o  Evaluating the results of a Normality test

o  Recommendations for implementation

o  Recommended reference textbooks.

Implementing cGMP quality systems and risk management approaches

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement the most current and acceptable cGMP quality systems and risk management approaches so that they meet the requirements set out in the FDA’s cGMP regulations, namely 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches describes an all-encompassing Quality Systems (QS) model and explains and highlights the way and extent to which the Quality model has to be consistent with the CGMP regulatory requirements for manufacturing drugs in the human, veterinary and biological categories.

FDA guidance on cGMP quality systems and risk management approaches is not mandatory

The FDA guidance on cGMP quality systems and risk management approaches also offers help to manufacturers who need to implement the Quality Systems in being in complete compliance with CFR Parts 210 and 211. However, these guidances on cGMP quality systems and risk management approaches are not obligatory or mandatory for drug manufacturers. They are not legally enforceable. Rather, like all other guidances, they are suggestive in nature and reflect the FDA’s thinking on a particular topic at a particular point of time. Although the FDA uses the word “should”, it only means something that is of a recommendatory nature.

Full compliance is expected

Even though the FDA’s cGMP quality systems and risk management approaches is not legally enforceable; that the FDA expects full compliance with its requirements is a given. Drug companies that fail to show complete compliance with the cGMP quality systems and risk management approaches are penalized. Such companies end up paying huge fines and face all sorts of issues and problems. So, it is in their best interest to show compliance with the FDA’s cGMP quality systems and risk management approaches.

A learning session on FDA guidance on cGMP quality systems and risk management approaches

The ways of implementing cGMP quality systems and risk management approaches will be the training a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. The speaker at this session is the highly acclaimed and experienced professional, Jerry Dalfors, who has for over four decades been helping drug companies in a business administration, consultative, technical and managerial role in the development and manufacture of highly regulated biopharmaceutical products.

This session on implementing cGMP quality systems and risk management approaches will guide participants on what they can do to minimize patient risk and increase ROI. The speaker will show how this is a better option compared to paying outside contractors to fix errors.

Understanding FDA guidance on cGMP quality systems and risk management approaches from two important perspectives

This learning is important from two perspectives. First, it will help participating companies learn the nitty-gritty of implementing cGMP quality systems and risk management approaches.

Second, Jerry will help a drug company that is in the business of manufacturing materials that are regulated by the respective country’s government to ensure that the design and established operations are going meet both the local regulations but also those of the places to which the product might be shipped.

Jerry will cover the following areas at this session:

CGMPs and the concepts of current quality systems, including quality by design and development, risk management, CAPA, Change Control, Management Responsibilities, Resources, Manufacturing and Evaluation Activities.

o  Terms and Definitions – with related acronyms

o  Quality Management System – Quality = Profitability and does all it can to minimize operator errors

o  Documentation Requirements – entering data, comments and making corrections

o  Management Responsibility and GMP/Quality Commitment

o  Quality Policy – General elements of the Quality Manual and Individual Training Requirements for each job description.

o  Human Resources – Individual employee files providing documented evidence of required education or experience and related training for the individual’s position

o  Purchasing, Incoming Control and Raw Material Release

o  Gowning, Environmental Control and Monitoring

o  Product Testing, Inspection and Document Review for Final Product Release

o  Incident Tracking, Change Control, CAPA and Annual Quality Review

http://www.compliance4all.com/control/w_product/~product_id=501172LIVE?Wordpress-SEO

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070337.pdf