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.

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 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/

Quality is everything for a product or service

Quality is everything for a product or service. Quality is defined in different ways. One of the well-known definitions of Quality is the ability of a product or service to reach expected levels of excellence. This is a simple theoretical definition. In practice, though, Quality is a highly painstaking area of activity that is necessary across all functions of all industries. If a product does not meet its quality requirements or criteria, it is doomed to failure.

An organization can understand Quality in different ways and give different definitions and connotations to the term, based on the nature of their business and what they perceive as excellence. It is understood and defined in differing ways by organizations. It can be perceived as a parameter against which standards or costumer expectations are measured. Can Quality be understood as a state achieved by a product or service, where it is has no shortcomings or defects? Can Quality also be a department or wing within an organization that is tasked with meeting Quality requirements? Is it possible to fix a standard for something as subjective as Quality?

Quality is a culture, a habit and a philosophy

Quality is these, and often, much more. It can be considered a culture and a philosophy in an organization, by which it continuously keeps meeting Quality requirements. Quality is at the very core of ensuring customer satisfaction, which in turn is the foundation for improved business success.

Get an understanding of how to inculcate Quality

Imparting an understanding of the various shades and interpretations of Quality is the purpose of a webinar that is being organized by Compliance4All, a highly acclaimed provider of professional trainings for the areas of regulatory compliance. At 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 be the speaker.

To get a thorough understanding of Quality in all its forms and interpretations, and to benefit from the several years of experience the speaker brings into Quality, register by logging on to http://www.compliance4all.com/control/w_product/~product_id=501157LIVE?Linkedin-SEO

All about balancing factors to meet Quality requirements and expectations

The most important teaching Susanne will impart is the ways by which to accomplish Quality standards in the backdrop of several factors, often arduous and conflicting. For instance, a high quality product or service has to be produced to please the stakeholders. Or, the customers could ask for more. In an area like medical devices, the need for meeting Quality requirements is extremely high, given its criticality to patients, whose life often depends on the quality of these products. And then, Quality standards and processes have to meet regulatory requirements, which are often long drawn and require diligence and meticulousness of the highest order. And on top of all these, Quality has to be accomplished to meet business needs, keeping limited resources at hand.

Susanne will help participants understand ways by which all these can be balanced in order to achieve Quality and meet these expectations. At this webinar, Susanne will cover the following areas:

o  FDA and NB expectations for Quality Systems

o  Lessons Learned from 483s and warning letters

o  How culture can impact Quality and compliance risk

o  Management commitment and responsibility

o  Maturity Modeling

o  Key capabilities

o  Roles and responsibilities

o  Quality planning and strategy

o  Tools and techniques

o  Best Practices.

It is necessary to understand the nature of the differences between GMP and GLP

Differences between GMP and GLP are important to understand for professionals who work in areas which involve these two different, yet related practices. Since the two appear somewhat similar in terms of their application and nomenclature; there is considerable scope for misunderstanding and confusion.

It is necessary to understand the nature of the differences between GMP and GLP because those who are involved in these two practices have different roles to perform in the course of their work.

 

Differences between GMP and GLP are pronounced in laboratory testing

The differences between GMP and GLP are pronounced in laboratory testing, in which they serve different purposes.

This is how one can understand the differences between GMP and GLP: While GLP is concerned with preclinical development; GMP is related to manufacturing. In other words, GLP is based on study, while GMP is based on process.

Another area of understanding the differences between GMP and GLP is that the chief purpose behind designing GMP is to show to the regulatory bodies such as the FDA or the EPA whether or not individual lots or batches of any regulated manufactured product have met the criteria for manufacturing set out by these agencies.

On the other hand, the core purpose of GLPs is the protection of the integrity of scientific data. They are meant to provide regulatory agencies with data that helps the agencies scrutinize and audit the scientific validity of research studies.

Not so clear-cut in the areas of validation

However, the differences between GMP and GLP are not so clear-cut in the area of the application of validation. There is some lack of clarity on which areas of validation studies should be done under GLP and which, under GMP. When it comes to this area, it all depends on what is being validated. This factor dictates whether it is a GMP or a GLP is to be applied, based on what the professional considers appropriate for the occasion.

GMP precedes GLP

The fact that GMP precedes GLP is a commonsensical way of understanding the differences between GMP and GLP. Generally, GMP governs the earlier stage of testing. The testing of release lots and the proof of their conformity to standards set out by the regulatory bodies are done by GMP.

The next stage of this process, namely the testing of these products’ safety and efficacy, is done as part of GLP. This is another aspect at which the differences between GMP and GLP can be highlighted.

 

 

 

A learning session

Compliance4All, a leading provider of professional trainings for areas of regulatory compliance, will be organizing a webinar, at which the differences between GLP and GMP will be explained. Joy McElroy, a senior professional in the pharmaceutical industry, will be the speaker at this learning session.

To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=501116LIVE/~sel=LIVE/~Joy_McElroy/~GLPs:_How_are_they_Associated_with_GMPs_and_SOPs

At this webinar, while explaining the difference between GLPs and GMPs and how they are associated with SOPs; Joy will cover the following areas:

o  What are Good Laboratory Practices

o  Why were they created

o  What is the objective of GLPs and how are they associated with GMPs and SOPs

o  Statistical Procedures for data Evaluation

o  Instrumentation Validation

o  Analytical and laboratory Certification

o  Documentation and Maintenance of Records

o  Consequences of Noncompliance

o  Disqualification and Reinstatement