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

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 and handling payment issues

A financial organization, or an organization involved in any business for that matter, faces the prospect of receiving duplicate, fraudulent or late payments. These are the typical payment issues an organization is likely to face at some point of time in its business.

Payment issues are something almost no organization is likely to be free from. Duplicate invoice payments, just one of the payment issues an organization is likely to face, account for losses of something like $100 million over a three-year period just for medium sized organizations. The amount is likely to be several times higher for large companies and those in the public sector, which most likely deal with billions of dollars in transactions.

Payment issues have their implications

The consequence of payment issues, be they duplicate, fraudulent or late payments, is whopping. It is likely to lead to business losses, because late payments, for instance, hinder investment into other productive activities by businesses. Although there are a number of sources at which payment issues can happen; it usually takes an organization quite a while to detect any payment issue, which could be duplicate, fraudulent or late payments. It also takes herculean efforts at times to get to the bottom of the payment issues.

Payment issues can happen due to a number of reasons

There is any number of reasons for which payment issues could arise. Manual data entry and processing, possible overlooking of characters while entering Accounts Payable (AP) or by Automated Clearinghouses (ACH) processors, oversights by manual checks and overlapping or duplication of payments while making payments from varied sources are just some of the reasons for which payment issues can occur with businesses.

Although the Sarbanes Oxley (SOX) Act has put in a number of checks and balances into the payment aspect of corporations; there are still a good number of loopholes that need to be e plugged if payment issues have to be addressed. How do organizations, especially those in finance, mitigate payment issues? What steps do they need to take to understand the regulations set out by the SOX Act, or take their own measures to prevent payment issues arising out of duplicate, fraudulent or late payments?

Learn the aspects of payment issues at a learning session

All these will be addressed at a very valuable learning session on this topic. The webinar, being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will have Ray Graber as speaker.

Ray is a senior BFSI professional who brings a deep and thorough understanding of banking, technology, and finance. To hear from him on how to understand and address payment issues such as duplicate, fraudulent or late payments; just register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501138?Wordpress-SEO

Insights for understanding payment issues

At this webinar, Ray will help participants understand how to foresee payments issues and strategize solutions. He will offer suggestions about how to put risk management plans in place to do this. The suggestions Ray will offer at this webinar will help participants from banks and corporations to get a clearer understanding of each other’s concerns and constraints, and ways of addressing them.

This session will arm them with the tools necessary for accurately auditing their existent processes and limit the potential for fraud. He will teach them how to understand the settlement process, which is part of the banking business. In other words, attending this session will equip participants with the insight needed for understanding payment issues and tackle them in relation to duplicate, fraudulent or late payments.

At this session, Ray will cover the following areas:

o  Payment System Risk Policy

o  FFIEC Action Summary for Retail Payments

o  Areas of Risk

o  Risk Assessment Activities

o  People, Processes, and Products

o  Is there an optimal organizational structure/for managing payments strategy?

o  Are there best practices that apply to my institution?

o  What are the hurdles in establishing an organization focused on the payments business?

o  Are there common pitfalls?

http://www.infor.com/content/whitepapers/detecting-prev-dup-invoice.pdf/

The importance of Design of Experiments (DoE)

Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.

Design of Experiments is a very important aspect of the important elements of a product, such as quality, reliability and performance. What Design of Experiments does is that it helps to examine and investigate the inputs that lead to poor quality. This insight leads the entity carrying out the Design of Experiments to use these to improve their quality standards.

 

Ruling out chance

Design of Experiments does not rely on chance or providence to bring about the quality that is required of an experiment. It arrives at the optimal set of procedures that are needed to get the required quality standards after a series of tests and experiments, so that the final result shows in the process that goes into the product.

Fundamentally, Design of Experiments helps to put in place a system of control for a product. All the ingredients that go into the inputs needed for obtaining a product of a defined standard or quality are scientific and precise. This precision and accuracy is arrived at after carrying out as many runs or series of Design of Experiments as needed to finally arrive at it.

An introduction to Design of Experiments

The ways of understanding Design of Experiments and applying their standards into production will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance. At this webinar, the speaker, William Levinson, an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt, who is the principal of Levinson Productivity Systems, P.C., will explain the fundamentals of Design of Experiments.

To gain a proper understanding of the principles of Design of Experiments and to get a grasp of how to implement this concept into your systems, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501202?Wordpress-SEO

An understanding of the significance level in hypothesis testing

William will make participants understand how to use Design of Experiments to identify and rule out the particular item or input that affects quality. The concept of significance level in hypothesis testing, which will serve as a basis for not only DoE, but also Statistical Process Control and acceptance sampling, will be explained.

A description of the other uses of DoE, such as supporting Corrective and Preventive Action (CAPA) and in process improvement, where it helps to identify and optimize the factors influenced by Critical to Quality (CTQ) characteristic, will be part of the learning that is on offer at this webinar.

 

 

Levinson will cover the following areas at this webinar:

·        Economic benefits of DOE

·        Hypothesis testing: the foundation of DOE, SPC, and acceptance sampling

o  Null and alternate hypothesis

o  Type I or alpha risk of concluding wrongly that the experiment differs from the control (or that a process is out of control, or that an acceptable production lot should be rejected)

o  Type II or beta risk of not detecting a difference between the control and the experiment, not detecting an out of control condition, and accepting a production lot that should be rejected

·        Factors, levels, and interactions

o  Interaction = “the whole is greater or less than the sum of its parts”. One variable at a time experiments cannot detect interactions.

·        Randomization and blocking exclude extraneous variation sources from the experiment.

·        Replication means taking multiple measurements to increase the experiment’s power.

·        Interpret the experiment’s results in terms of the significance level, or quantifiable “reasonable doubt” that the experiment differs from the control.

http://support.minitab.com/en-us/minitab/17/topic-library/modeling-statistics/doe/basics/what-is-a-designed-experiment/

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes better, bring down turnaround time and reduce costs, and to establish standard procedures on how to implement 21 CFR Part 11.

Compliance with 21 CFR Part 11 is necessary for reasons that go beyond just ensuring IT security. It is also a solid and foolproof means to ensuring efficiency and economy of electronic records. 21 CFR Part 11 compliance for electronic records and signatures is also indispensable for ensuring patient safety. All these factors have led the FDA to require compliance with 21 CFR Part 11 electronic records and signatures.

Compliance with 21 CFR Part 11 is terribly tough, but mandatory

Compliance with 21 CFR Part 11, its good intentions notwithstanding, is quite complex. Companies that seek to transition to electronic records are hesitant and fearful of 21 CFR Part 11, because understanding how to implement 21 CFR Part 11very difficult and time consuming. It requires adherence to all the complex rules and protocols that the FDA has put in place. Entities that need to be compliant with 21 CFR Part 11 have to meet the requirements of the FDA which deal with data security and patient safety.

Yet, compliance with 21 CFR Part 11 is not optional. How does a company ensure implementation of 21 CFR Part 11 compliance for electronic records and signatures? What are the nitty-gritty and nuances of 21 CFR Part 11 implementation?

A webinar from Compliance4All

The specific ways of doing this will be imparted at a webinar being organized by Compliance4All, a reputable provider of professional trainings for all areas of regulatory compliance. Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker at this webinar. To gain learning about 21 CFR Part 11 implementation, enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501132LIVE/~sel=LIVE/~Edwin_Waldbusser/~21_CFR_Part_11_-_Compliance_for_Electronic_Records_and_Signatures

The speaker will help participants get an understanding of what 21 CFR Part 11 is and why it is important for industries to comply with it. The most important learning this webinar will impart is that it will help participants remove the fear and anxiety associated with ensuring 21 CFR Part 11 compliance for electronic records and signatures. This learning will help them approach this vital activity with confidence, so that they will not become targets of 483’s and Warning Letters that result from noncompliance.

A major topic Edwin will take up at this webinar is the rather stringent and punitive nature of this regulation. 21 CFR Part 11 was considered so harsh when it was introduced that it forced the industries that come under it to altogether give up on transiting to electronic records. Such was the fear and awe it incited. When industry made a plea to the FDA on this aspect, the regulatory body refused to dilute the severity of the requirements, but only said that it would take up implementation selectively. The speaker will talk on this aspect of 21 CFR Part 11 compliance for electronic records and signatures.

He will cover the following areas at this webinar:

o  Company certification

o  Records covered

o  Audit trails

o  Open/closed system access rules

o  Electronic signatures

Training requirements.