Introduction to the Biomedical Industry

The Biomedical Industry. The following article and podcast presents an introduction to the biomedical industry, specifically the manufacturing of medical products. An introduction to the regulatory environment in which these organizations operate is presented. The concept of regulatory compliance, quality systems, ISO international quality standard, and regulatory consequences of not complying with FDA requirements are presented.

The following is the podcast for this article.

Emprendiendo – Episodio #001

Quiero establecer un negocio…. ¿Como lo hago?

¿Estás pensando en establecer un pequeño negocio? ¿Quieres hacer algo diferente o adicional a tu trabajo actual?

Cada día vemos mas personas interesadas en establecer un pequeño negocio o microempresa. Las razones son diversas.  Algunas personas interesan obtener dinero adicional, ya sea para cubrir gastos extraordinarios, realizar viajes, comprar artículos no esenciales o de entretenimiento, electrónicos, darse gustos, etcétera, etcétera.   O simplemente quieren salir de su rutina y entretenerse realizando algo diferente.

Este es el tiempo en la que vemos cada vez más personas emprendedoras. Pueden estar interesadas en obtener su fuente de ingreso principal, o simplemente interesan un pasatiempo, conocer personas y entrar en el mundo de los negocios.

Encontramos profesionales que poseen un talento y quieren sacarle valor.  Laboran 8 horas (¡o más!) en su trabajo principal y en su tiempo libre diseñan o venden ropa, les interesa la decoración de hogares, hacen prendas, artesanías, confeccionan alimentos, proveen servicios, en fin, hay un sin numero de oportunidades para emprendedores.

Estamos en tiempos donde tenemos acceso a la información fácilmente.  Si tenemos alguna duda, o queremos conocer algún tema podemos acceder a nuestro teléfono, tablet o computadora para la búsqueda de información. Son los tiempos idóneos para los emprendedores.  Hoy en día, crear una tienda es mas sencillo que antes.  Incluso, por medio de la internet o el comercio electrónico, tenemos la oportunidad de establecer una tienda virtual sin necesidad de grandes inversiones de dinero.

Muchos de nosotros no tenemos una preparación formal en negocios, pequeñas empresas o microempresas.  Nos motiva el querer emprender y vamos aprendiendo sobre la marcha. En próximos posts estaremos enfocándonos en ese personal que se considera emprendedor e interesa obtener conocimientos y herramientas para sacar su negocio hacia adelante.

¡Síguenos!

 

 

 

Careers in the Biomedical Industry – # 001

Working in the Medical Products Manufacturing Industry 

 Welcome to the series Careers in the Biomedical Industry, specifically, in the medical products manufacturing industry.

This series is focused on the personnel with a background in the areas of science and technology. These areas focus mostly on the scientific, technical and laboratory aspects, however, there are topics, concepts, areas of knowledge and skills that are needed in the labor market in the industry. There are careers whose job titles are very different from what we know from college.  Positions such as validation specialists, CAPA specialists, QA specialist, among others.

For example, an important area in the industry that it is convenient to learn is the CAPA system.   When a failure or deviation occurs, an investigation is required to determine the root cause.   Once the cause of the failure or problem is identified, an action plan must be established to correct and prevent from happening again.  All of this must be documented because is required by law, regulations and international quality standards.

The Food and Drug Administration (FDA) expects this to happen. When FDA inspect a facility, many times the first thing to require is the list of Non-Conformities and CAPA. This investigation should be well robust and documented within a defined time.  In the medical product manufacturing industry, there are trained personnel dedicated to conduct these failure investigations or working in the CAPA area.

In the next capsules we will be discussing some of these functional areas in which you   can work, so that you understand the position and have a general knowledge of the roles.

If you are preparing for a job interview and you have no experience in the industry, at least know and understand the terminology that is used day by day.

For example, is recommended that you know what CAPA is, corrective and preventive actions, know some of the tools to investigate failures, and the Root Cause Analysis.

These are some examples of terms you will be listening no matter what type of industry you go to: pharmaceutical, medical devices, biotechnology, or food.

You’re probably a student interested in learning about the industry.  You’re deciding what you’re going to do in your future and where to look for work, or you just want to complement the knowledge in your area.

It is convenient that as you learn these e keywords, think of previous experiences, whether job related or academic, at university, and identify how you can demonstrate in a job interview, that you possess those skills.   For example, that you can conduct a failure or nonconformance investigation, establish a corrective and preventive action plan.

You have academic experience… you have the knowledge and experience!  It’s important that even if you don’t have a lot of work experience, you show that you have the knowledge and know how to apply it.

You have the knowledge, understand the logic, background and requirements. Show that you are willing and passionate to learn.  Document that experience and knowledge in your resume and demonstrate it in the job interview.

At Biobusiness Research we share knowledge.

Join us in this series of informative capsules that we will be publishing led by Dr. Eileen Ruiz, founder of Biobusiness Research.

Careers in the Biomedical Industry – Episode #001: https://youtu.be/1dExz1Oejv8

 

 

Wash your Hands with Water and Soap. The Science Behind It.

wash your hand the science behind it

By: Eileen Ruiz, PhD

 

During this coronavirus outbreak, experts are telling us to wash our hands with water and soap.

The World Health Organization (WHO) state that people should “wash their hands frequently with soap and water” to prevent infection with the novel coronavirus.
Soap is the best defense against diseases. It prevents and stop the virus spreading, therefore, helps control the infection rates.

Then, why water and soap are so effective?

Soap dissolves the lipid membrane and the virus becomes inactive…, it falls apart.

 

Let’s start by understanding what a virus is and how is the coronavirus structure.

What is a virus?

Viruses are particles composed mainly of genetic material known as nucleic acids (either RNA or DNA) and proteins.  The proteins are like a protective coat, called capsid.  The capsid may be surrounded by an additional coat called the envelope.

Viruses are not living organisms as for example, bacteria.  A virus is a particle. It requires a living organism to replicate.  They invade cells of other living things (host cells) and use those cells to multiply. The virus particle attached to the host cell, penetrate it, and then uses the host cell’s machinery to replicate its own genetic material.

Coronavirus Structure

Coronaviruses (CoVs) are enveloped RNA viruses.  It is composed of ribonucleic acid (RNA), proteins and lipids.

The virus is characterized by protein spikes that project from their surface.

cdc coronavirus
Illustration Source: CDC

The coronavirus is named after the crownlike spikes that protrude from its surface. The spikes are proteins that project from their surface.

Coronavirus particles are surrounded by an envelope of lipid molecules. This “oily” envelop can break apart on contact with soap.

coronavirus structure
Illustration Source: New York Times

Soap

Soap has a hybrid structure. It is like a pin-shaped molecule.  Soap is an “amphiphile molecule:  it has a hydrophilic head that bonds with water and a hydrophobic tail that repels water and link with the lipids.

 

soap
Illustration Source:
 Brookhaven National Lab   

Soap are molecules that have a dual nature. One end of the molecule is attracted to water and repelled by lipids (fats) and proteins. The other side of the molecule is attracted to lipids (fats) and is repelled by water.

How it works on the virus? One side of the soap molecule (the one that is attracted to lipid) buries its way into the virus’s lipid and protein shell. The chemical bonds holding the virus together are not strong, so it breaks the virus’s coat. The virus is pull apart, get soluble in water, and disintegrates.

 

Soap is a surfactant. One end of the soap molecule is hydrophilic (water-loving) and binds to water; the other end is hydrophobic (water-hating) and binds to oil molecules. In water, soap molecules form a ring around the drop of oil. This structure is called a micelle.

 

When you wash your hands with soap and water, microorganisms and viruses are surrounded with the soap molecules.  Hydrophobic tails attempt to evade water and try to “escape” from water.  It wedges into the lipid envelop of virus and bacteria, making them apart.  The structure rupture, proteins escape, and virus particle are inactive.

Hand Washing with Water and Soap

What happens when you wash your hands with water and soap?

Hand washing with soap uses mechanical action that loosens bacteria and viruses from the skin, rinsing them into the drain. Rubbing your hands together and rinsing provides a friction that destroys virus.

The Centers for Disease Control and Prevention (CDC) say that best practices for hand washing include rinsing the hands with water, applying soap and scrubbing the palms, the back of the hands, between the fingers, and under the fingernails.

Make sure to focus on places people tend to forget; the back of your hands, between your fingers, and under your nails, where microbes tend to build up.

Scrub for at least 20 seconds. A person should scrub for at least 20 seconds before rinsing the soap and drying the hands with a clean towel.  It is recommended at least 20 seconds to allow the soap to perform its chemical action and to interact with the virus particle.  It needs some time to work.

Even if it the soap does not destroy every virus particle, it helps to get rid from the hands with soap and water.

Drying is also important.  The friction with a clean hand towel removes bacteria and viruses that haven’t been removed with the soap and water.

The important is to remove the virus from your hands. This prevents the spreading to your body or other surfaces.  This is an important step to help protect yourself and protect others from this pandemic.

 

References:

Anthony R. Fehr and Stanley Perlman. 2015. Coronaviruses: An Overview of Their Replication and Pathogenesis.  Methods Mol Biol.; 1282: 1–23. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4369385/

Corum, J. and Zimmer, C. (2020, March 13). The New York Times.  How Coronavirus Hijacks Your Cells. Retrieved from: https://www.nytimes.com/interactive/2020/03/11/science/how-coronavirus-hijacks-your-cells.html

Center for Diseases Control and Prevention. When and How to Wash Your Hands.  Retrieved from https://www.cdc.gov/handwashing/when-how-handwashing.html

Resnick, B. (2020, March 11). How soap absolutely annihilates the coronavirus. Retrieved from: https://www.vox.com/platform/amp/science-and-health/2020/3/11/21173187/coronavirus-covid-19-hand-washing-sanitizer-compared-soap-is-dope

El Coronavirus

 

cdc coronavirus

Todos nosotros, de una manera u otra hemos escuchado recientemente la palabra coronavirus.  Enciendes la televisión, buscas las redes sociales, y en las noticias, todo el mundo está hablando del Coronavirus, COVID-19 y SARS-CoV-2.

SARS-CoV-2, un coronavirus, es el virus que causa COVID-19.

Entonces, ¿qué es el coronavirus?

El coronavirus no es nuevo.  Fue descrito por primera vez en la década de 1960.  Los coronavirus son una familia de virus, que incluye los relacionados con el síndrome respiratorio agudo grave (SARS-CoV), el síndrome respiratorio de Oriente Medio (MERS-CoV) y el reciente COVID-19 (2019-CoV).  Es un virus basado en ARN (o RNA).  Recibe su nombre debido a su estructura de una corona de proteínas azucareras que se proyecta a partir de la envoltura que rodea la partícula.  Su estructura parece que posee una corona.

Coronavirus – SARS-CoV-2

A finales de diciembre de 2019 se notificó un brote reciente de una enfermedad respiratoria en China.  El brote es causado por un virus.  Los científicos han nombrado el virus como “SARS-CoV-2” que significa Coronavirus del Síndrome Respiratorio Agudo Severo 2 (Severe Acute Respiratory Syndrome Coronavirus 2).

Es una forma novedosa o nueva de una familia existente de coronavirus. No ha sido previamente identificado en humanos.   La enfermedad que causa ha sido nombrada “enfermedad del coronavirus 2019” o coronavirus disease 2019  (“COVID-19”).

Fue detectado por primera vez en la ciudad de Wuhan en China el 31 de diciembre de 2019.  En febrero de 2020, se había detectado en 57 localidades a nivel internacional.  Ya en marzo, es una emergencia sanitaria a nivel global.

Según los Centros para el Control y la Prevención de Enfermedades (CDC), los Coronavirus son una gran familia de virus que son comunes en diferentes especies de animales, incluyendo camellos, ganado, gatos y murciélagos.  Se dice que el virus tiene su origen de los murciélagos.

En raras ocasiones, los coronavirus provenientes de animales pueden infectar a las personas y luego propagarse entre las personas.  Parece que es el caso de este virus que ha sido exitoso propagándose de persona a persona.

Propagación

Muchos de los primeros pacientes asociados con el brote de COVID-19 en Wuhan, China, tenían alguna relación con un gran mercado de mariscos y animales vivos.  Esto sugirió propagación de animal a persona.  Más tarde, se notificaron pacientes que no tuvieron exposición a los mercados de animales, lo que indica la propagación de persona a persona.

Se informó de la propagación sostenida de persona a persona en China, y luego, fuera de China.

COVID-19 es una nueva enfermedad. Hay más para aprender acerca de cómo se propaga, la gravedad de la enfermedad que causa, y en qué medida puede propagarse. El virus que causa COVID-19 parece estar extendiéndose de forma fácil y sostenible en la comunidad.

Según los CDC, se cree que el virus se propaga principalmente de persona a persona.  Se propaga entre personas que están en estrecho contacto entre sí (dentro de unos 6 pies), y a través de gotas respiratorias producidas cuando una persona infectada tose o estornuda.

Puede ser posible que una persona pueda obtener COVID-19 tocando una superficie u objeto que tiene el virus en él y luego tocando su propia boca, nariz, o posiblemente sus ojos, pero esto no se cree que sea la forma principal en que el virus se propaga

Síntomas

Las enfermedades notificadas han oscilado entre síntomas leves hasta enfermedades graves.  Desafortunadamente, la muerte también ha sido reportada.

Los síntomas pueden aparecer 2-14 días después de la exposición*:

  • Fiebre
  • Tos
  • Dificultad para respirar

La infección por coronavirus en forma grave puede causar neumonía, síndrome respiratorio agudo grave, insuficiencia renal e incluso la muerte.

Prevención

Es un nuevo virus; los científicos están aprendiendo sobre ello diariamente.  No hay vacuna para prevenirlo hasta  ahora.

Los CDC recomendaron medidas preventivas para ayudar a prevenir la propagación de enfermedades respiratorias, entre ellas:

  • Evite el contacto cercano con personas enfermas.
  • Evite tocarse los ojos, la nariz y la boca.
  • Quédate en casa cuando estés enfermo.
  • Cúbrase la tos o estornude con un pañuelo de papel y, a continuación, tire el tejido a la basura.
  • Limpie y desinfecte los objetos y superficies tocados con frecuencia con un spray o toallita de limpieza doméstica regular.
  • Lávese las manos a menudo con agua y jabón durante al menos 20 segundos, especialmente después de ir al baño; antes de comer; y después de sonarse la nariz, toser o estornudar. Si el agua y el jabón no están disponibles fácilmente, use un desinfectante de manos a base de alcohol con al menos 60% de alcohol. Lávese siempre las manos con agua y jabón si las manos están visiblemente sucias.

Los CDC no recomiendan que las personas que están bien usen una máscara facial para protegerse de las enfermedades respiratorias. Las máscaras faciales deben ser utilizadas por personas que muestren síntomas de COVID-19 para ayudar a prevenir la propagación de la enfermedad a otras personas.

Para obtener información adicional, consulte la página del Centro para el Control y la Prevención de Enfermedades (CDC): https://www.cdc.gov/coronavirus/2019-ncov/

 

The Coronavirus

Everybody in one way or another has listened recently the word coronavirus.  You turn on the TV, look at Facebook, and in the news, everyone is talking about the Coronavirus, COVID-19 and SARS-CoV-2.

SARS-CoV-2, a coronavirus, is the virus that causes COVID-19.

cdc coronavirus

Then, what is the coronavirus?

Coronavirus is not new.  It was first described 1960s.  Coronaviruses are a family of viruses, that includes those related to the Severe acute respiratory syndrome (SARS-CoV), Middle East respiratory syndrome (MERS-CoV), and the recent COVID-19 (2019-CoV).  It is an RNA-based virus.  It gets its name from a corona or ‘crown’ of sugary-proteins that projects from the envelope surrounding the particle.

 

Coronavirus – SARS-CoV-2

A recent outbreak of a respiratory disease was reported at the end of December 2019 in China.  The outbreak is caused by a virus.  Scientist has named the virus as “SARS-CoV-2” which means Severe Acute Respiratory Syndrome Coronavirus 2.

It is a novel or new form of an existing family of coronaviruses. It has not been previously identified in humans.   The disease it causes has been named “coronavirus disease 2019” (“COVID-19”).

It was first detected in the Wuhan City in China on 31 December 2019.  On February 2020, it has been detected in 57 locations internationally.

According to the Centers for Diseases Control and Prevention (CDC), the Coronaviruses are a large family of viruses that are common in different species of animals, including camels, cattle, cats, and bats.  It is said that the virus has its origin from bats.

In rare occasion, animal coronaviruses can infect people and then spread between people.  It seems it is the case for this virus.

 

Spread

Many of the early patients associated with the COVID-19 outbreak in Wuhan, China had some relation to a large seafood and live animal market.  This suggested animal-to-person spread.  Later, patients that did not have exposure to animal markets were reported, indicating person-to-person spread.

Sustained person-to-person spread were reported in China, and then, outside China.

COVID-19 is a new disease. There is more to learn about how it spreads, the severity of illness it causes, and to what extent it may spread. The virus that causes COVID-19 seems to be spreading easily and sustainably in the community.

According to CDC, the virus is thought to spread mainly from person-to-person.  It spread between people who are in close contact with one another (within about 6 feet), and through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads

 

Symptoms

Reported illnesses have ranged from mild symptoms to severe illness.  Unfortunately, death has also be reported.

Symptoms may appear 2-14 days after exposure*:

  • Fever
  • Cough
  • Shortness of breath

Coronaviruses infection in severe form can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.

 

Prevention

It is a new virus; scientists are learning about it daily.  There is no vaccine to prevent it as of now.

CDC recommended preventive actions to help prevent the spread of respiratory diseases, including:

  • Avoid close contact with people who are sick.
  • Avoid touching your eyes, nose, and mouth.
  • Stay home when you are sick.
  • Cover your cough or sneeze with a tissue, then throw the tissue in the trash.
  • Clean and disinfect frequently touched objects and surfaces using a regular household cleaning spray or wipe.
  • Wash your hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after blowing your nose, coughing, or sneezing. If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60% alcohol. Always wash hands with soap and water if hands are visibly dirty.

 

  • CDC does not recommend that people who are well wear a facemask to protect themselves from respiratory diseases. Facemasks should be used by people who show symptoms of COVID-19 to help prevent the spread of the disease to others.

 

For additional information refer to the Center for Disease Control and Prevention (CDC) page:  https://www.cdc.gov/coronavirus/2019-ncov/

The Life Sciences Industry

 

In this section, we offer a summary of the life sciences and biomedical industry sector.

This industry is based on the application of knowledge for the development of innovative products intended to use for the prevention and treatment of health conditions.  It is an interdisciplinary industry where we find the interaction and application of different branches of sciences such as Biology, Medicine, Chemistry, Biochemistry, Molecular Biology, Microbiology, and Pharmacology among other disciplines.

Science and Engineering knowledge is integrated for the development and innovation of products. Multinational companies are engaged in research, development, manufacturing, marketing and selling of products for the prevention and treatment of health conditions.

The biomedical industry is driven by education, research, innovation and entrepreneurship. It is divided into several segments.

 

Life Sciences Sectors 

The sector includes research facilities, universities, hospitals, medical education, biomedical researchers, pharmaceutical and medical device manufacturers, biotechnology companies, testing laboratories and other interested in the search of knowledge and its application.

Research is continually conducted to find and develop new products and technologies that can be used to cure, treat, protect and improve health.

The sector is widely distributed in the United States and around the world. It is a global market. The biomedical industry has an important role as an economic engine in many states and countries.

Those working in this sector have the satisfaction of being able to support and contribute to global health and well-being. Manufactured products are distributed to different parts of the world. Even the services provided can be global. Each employee can have an impact on the life, health and well-being of people around the world.

 

Devices and medical products  

One sector within this industry is the medical devices, technologies and medical products.

 

What are medical devices?

They are a series of equipment, instruments or objects used for therapeutic purposes.  According to the Food and Drug Administration (FDA), medical devices include instruments, apparatus, implants, in vitro reagents, and components or accessories intended for use in diagnosing diseases or other conditions, or in the cure, mitigation, treatment or prevention of diseases (www.fda.gov).  It has a physical or mechanical effect in the body.

According to ISO 13485 “Medical Devices–Quality Management Systems–Requirements for Regulatory Purposes” a medical device is any device, equipment, machine, implant, software with a function that can alleviate pain, to give a treatment, using physical or mechanical means and not chemical action.

The purpose of these products is to diagnose, prevent, monitor, treat, alleviate conditions, diagnose, monitor, wound treatment, and joint replacement.  They can even support and sustain life as for example pacemakers.  This Industry design and manufactures diverse products ranging from dental floss to pacemakers.

It can range from surgical instruments, heart valves, hospital beds, catheters, serum, serum bags, pacemakers, neuro stimulators, orthopedic process screws, spine support, diagnostic kits, glucose monitoring, intraocular lenses, orthopedic implants, prostheses and defibrillators, among many other products.

It has a variety of products and therefore varies in the complexity and types of regulatory controls.  There are three classifications according to the product, complexity and regulatory controls. Class 1 is the less complex, Class 2 (intermediate) and Class 3 are the ones that sustain life. If you go to a company and they tell you that they manufacture medical devices Class 3, means that are products that sustain the life and will have greater regulatory controls.

In the United States, the industry is highly regulated by the Food and Drug Administration, known as the FDA.  Each country has its own regulatory agencies that conduct inspections to ensure that product manufacturing is carried out following good manufacturing practices and the highest quality standards.

Medical devices products are intended to affect the structure or function of the body. Their main mode of action is not by a chemical reaction in the body, unlike the pharmaceutical industry that its mode of action is based on chemical intervention.

 

Pharmaceutical

Other important sector that is widely recognized is the pharmaceutical industry.  This industry is responsible for the development and manufacture of medicines. It is characterized by research and development activities to produce new drugs, therapeutic products, vaccines, biological, diagnostic substances and dermatological products. Its mode of action is by chemical mediation in the body. Pharmaceuticals are highly regulated in the United States by the FDA through the 21 CFR 211 “Current Good Manufacturing Practices for Finished Pharmaceuticals”. Each country will have the applicable regulatory agency.

 

Laboratory and Research 

Research, medical and testing laboratories are another area within the life sciences sector. It Includes research centers, tests and clinical labs. This segment is dedicated to biomedical and clinical research, biotechnology and medical testing among other areas.

 

Distribution  

The distribution sector is related to the distribution of medical, biomedical, biotechnology, and pharmaceutical materials and products. It includes companies that coordinate the delivery of  pharmaceuticals, medical devices and biological products from the manufacturing facility to distribution centers and to the final user or client.

It requires the implementation of specialized technologies for storage and highly regulated monitoring systems during distribution.  Distributors develop logistics competencies for the transport of therapeutic products, including biological products, devices, sensitive medical equipment, seeds and other biomedical products.

 

Life Sciences Workforce   

life sciences industry

This industry employs highly educated and trained workers. Personnel with different background and areas of expertise work in a teamwork environment to achieve common objectives, goals and metrics.

We find professionals with extensive experience, such as laboratory technicians, microbiologists, chemists, biotechnologists, scientists and engineers.  People with knowledge in Business Administration can explore opportunities in the area of Finance, Operations, and Supply Chain.

The average wage of employees working in the sector tends to be relatively higher than other industries due to the highly specialized training and skills required.  It is a complex industry in terms of product diversity, technologies, therapies, customers, requirements and regulations.  This industry is based on the development and use of biological, biomedical, and engineering knowledge, discoveries and scientific innovation.

Progress is made daily in the knowledge of biological processes and systems. Biomedical workforce is in an active search to understand how to use that knowledge and discoveries to create products that can improve health, develop new technologies and improve existing ones.

As any global company, they seek to be the first to introduce a product into the market, expand its scope, product portfolio, return of investment for its shareholders, and to improve health and quality of life. This is performed in compliance with the regulations and the highest quality standards.

This episode provides a summary of the life sciences and biomedical industry sector, which includes the pharmaceutical, devices and medical products, laboratory and research, and distribution.

This introduction is part of the course Understanding the Life Sciences Industry, created by Biobusiness Research.  You can access the course on http://www.biobusinessresearch.net

https://biobusiness.podbean.com/e/004-life-sciences-industry-overview/

 

 

Understanding the Life Sciences Industry (Online Course)

Understanding the Life Sciences Industry

Learn how it is to work in the medical products manufacturing industry.

This online, self-paced, introductory course is designed for those interested in a career in the life sciences and biomedical manufacturing industries such as the pharmaceutical, medical devices and biotechnology. The content focuses on individuals who want to understand what it is like to work in the industry.

It is useful for those who are interested to work in the industry, but do not know their organizational structure, or the dynamics of working in a highly regulated manufacturing environment, controlled by quality systems.

This program is designed for those who aspire to start a career or just want to know what it is like to work within a highly regulated industry such as the biomedical or life sciences industry.  We will provide a general overview of the industry, with emphasis on the manufacturing of pharmaceutical and medical products. Our goal is to help you understand the main roles and responsibilities and be better prepared for the job search. In general, we will present some of the important elements you need to understand about the industry.

At the end of this course you will learn about medical devices and pharmaceutical products. You will understand the rules that every employee who works in this highly regulated environment should follow. We will discuss some of the careers and functional areas that you can find in this industry. You will get the basic knowledge about quality, quality systems, audits, and non -conformities. In addition, you will have an overview of the business and regulatory aspects related to the sector. It is important that you recognize the international regulations and standards that each employee must follow to ensure that the product, processes and services meet quality standards and are safe to use.

The topics to be addressed include an introduction to the manufacturing industry, quality systems, international quality standards such as ISO, regulations, conformity and non-conformity, quality system audits, and Corrective and Preventive Actions, known as CAPA.  The CAPA system is related to investigating the cause of non-conformities and establishing the actions taken to correct the Non-conformity (corrective actions) and what actions are being implemented to prevent non- conformity (preventive actions) from occurring.  It is a highly regulated environment. Continually we are being audited by external agencies and internal auditors.

In addition to the regulatory side, there are other concepts that are part of the everyday vocabulary for those who work in this environment.  For example, production process controls, how to work in a controlled environment area, contamination control to guarantee the quality of the final product, environmental monitoring of production areas, microbiological quality controls, validations, equipment qualifications, project management, failures and non-conformity investigations, corrective and preventive actions (CAPA), and continuous improvement are just some of the areas of knowledge that are valued in the industry.

It is also important that you know what it is like to work in a clean room or controlled Environment area (CEA). These areas have controls in terms of cleanliness and contamination. The manufacturing environment is continuously monitored through microbiological tests, particle counts, temperature, humidity, differential pressure, and air changes, among others.

Several tests are carried out in the manufacturing areas to determine if complies with quality parameters and specifications. The area is controlled. It must meet the minimum requirements according to the quality standards. This is a little different scenario for those who have not been exposed to contamination controls in the working areas.

At the end of the course, you will have an overview of the role of quality control (QC) laboratories, which perform tests to ensure that the organization processes and products meet quality.  Laboratories, such as microbiology and chemistry, are usually part of the quality control function.

The regulatory and compliance area is critical in this type of industry.  We must follow the law, quality standards, and Good Manufacturing Practices (GMPs).  If we fully follow them, we are in compliance.  Compliance is a word that is part of the daily vocabulary in the industry. If we are not in compliance, quality events are generated, observations or audit findings are given, and the company has problems.  The quality role is to ensure that all elements of the Organization are in compliance.

Register now for the course in the following address:life sciences industry

https://www.biobusinessresearch.net/understanding-the-life-sciences-industry

 

 

 

 

Quality Assurance en la Industria

Taller: Quality Assurance in the Life Sciences Industry.

Conoce el rol del personal de QA en la Industria en el taller que ofrecerá Biobusiness Research el domingo, 27 de Octubre, en San Juan.

El personal de calidad es responsable de asegurar que los procesos y productos cumplan con los procedimientos, especificaciones y requisitos regulatorios en industrias como la farmacéutica, biotecnología, dispositivos médicos, alimentos, entre otras. Entre las funciones del profesional de Calidad incluye el Aseguramiento de Calidad (QA), Control de Calidad (QC) y Cumplimiento Regulatorio.

El taller está diseñado para introducir al estudiante, recién graduado y/o personal con poca experiencia al área de QA con énfasis en las industrias de manufactura.   El programa prepara a los estudiantes para entender la industria y prepararse para la búsqueda de empleo en este sector en y fuera de Puerto Rico.

El personal de calidad es responsable de asegurar que los procesos y productos cumplan con los procedimientos, especificaciones y requisitos regulatorios en industrias como la farmacéutica, biotecnología, dispositivos médicos, alimentos, entre otras. Entre las funciones del profesional de Calidad incluye el Aseguramiento de Calidad (QA), Control de Calidad (QC) y Cumplimiento Regulatorio.

El taller está diseñado para introducir al estudiante, recién graduado y/o personal con poca experiencia al área de QA con énfasis en las industrias de manufactura.   El programa prepara a los estudiantes para entender la industria y prepararse para la búsqueda de empleo en este sector en y fuera de Puerto Rico.

Entre los temas a discutir se encuentran:

  • Elementos de un Sistema de Calidad
  • Quality Assurance (QA) / Quality Control (QC)
  • Rol del Representante de Calidad
  • Buenas Prácticas de Manufactura (cGMP)
  • Estándar de Calidad ISO
  • Documentación, SOPs, Registros
  • Identificación y Traceabilidad de Producto
  • Control de Procesos
  • Laboratorios de Calidad
  • Liberación de Materiales, Servicio o Producto
  • Investigaciones y Acciones Correctivas / Preventivas (CAPA)
  • Adiestramientos
  • Auditorías
  • Control de Equipos
  • Mejoras de Procesos

Para información y registro puede acceder el siguiente enlace:

https://www.eventbrite.com/e/quality-assurance-qa-in-the-life-sciences-industry-san-juan-tickets-75969654281

Por otro lado, si no puede acceder el adiestramiento en San Juan, puede registrarse en la versión online en un formato autodirigido (self-paced) a través de la página www.biobusinessresearch.net.

La página del curso online es:  https://www.biobusinessresearch.net/quality-assurance-qa-el-rol-del-departamento-de-calidad-en-la-industriaQA

What is Biotechnology?

Biotechnology is an area of interest in the current years. It is a merge between biology and technology. It is like a “joint venture” between science and industry. Biotech is based on the biology, as it study microorganisms and living systems. These microorganisms have components that are molecules. The molecules include the DNA, RNA, proteins and carbohydrates.

Biotechnology is based on the application of biological knowledge to create products with a benefit to the population. Industries in this sector uses the biological molecules to develop products for a commercial purpose. Products may include food, health care products, pharmaceuticals, and vaccines. It is also used in agriculture to improve crop yields and prevent damage.

Biotech medicine is an area of commercial applications. They are based on components similar to proteins used by the body. These medicines are manufacture using living organisms or microorganisms that are genetically modified to produce the molecule of interest.

Usually biotech medicines are injected in the body because are large complex molecules that can be destroyed by the normal digestion process if ingested by mouth.

Most of us are more familiar with the traditional chemical or drug-based medicines that are taken in solid or liquid form. Usually they are contained within a pill, tablet or capsule and are smaller molecules than proteins.

Several companies are investing in research and development in healthcare and agricultural applications to produce new and improve products. This is an interesting area to explore if you want to learn about the interaction of science, technology and industrial processes.

#biobusinessresearch #promotelearning #biotech #biotechnology