What You Need To Know For Validated Systems?

Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out because computer systems used in highly regulated companies house very sensitive and valuable information.

Data relating to valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information are usually placed in these systems, which is what makes them targets of cyberattacks. Cyber attackers have become so sophisticated and emboldened in recent times that they have not even spared the White House.

Computer Systems Validation has a major role

Companies that hold vital information should ask themselves many questions on this topic. Some of these include: Will my company able to cope with a breach of one of our validated systems? How secure is the information we have stored in the cloud? Are we conducting adequate due diligence on our cloud provider?

Even as the dependence on the cloud, by which life sciences companies are increasingly implementing and deploying systems in a cloud environment goes up; the procedures and controls to effectively manage and protect their validated systems environments is somewhat inadequate.

In the current situation of higher and stronger attacks on computer systems unaided by solid safety and security guarantees; Computer Systems Validation (CSV) has a critical role to play. Validation engineers need to take a serious relook at testing strategies. They must look at systems that provide objective evidence that computer systems have the requisite technologies, processes, and practices designed to protect networks, computers, programs, and data from attack, damage, or unauthorized access.

There is an acute need for validation engineers to be more vigilant in today’s systems environment that is sometimes hostile, in order to detect and prevent cybersecurity issues before they become real problems. Proper and diligent CSV goes a long way in helping to ensure that this happens.

Valuable learning on lean validation 

The ways of doing this will be the learning a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Valarie King-Bailey, who is the CEO of OnShore Technology Group, an independent Chicago-based consultancy founded in 2004 specializing in Independent Validation and Verification (IV&V) services and solutions; will be the speaker at this webinar.

Please enroll for this webinar by visiting concept of Cybersecurity Qualification

Full aspects of cybersecurity

The regulatory, legal, compliance and business risks associated with the threat of cybersecurity constitute the core of this webinar. It will address the unique threat of cyberattacks on validated systems environments and discuss how to mitigate and protect validated systems.

As validation engineers continue to conduct IQ, OQ, PQ, CyQ testing must be added as a defense against cyberattacks to validate computer systems.  Valerie will discuss the NIST Cybersecurity framework and how it can be applied to validated computer systems. She will also discuss a new level of qualification for validated computer systems known as Cybersecurity Qualification (CyQ), a concept she will introduce at this webinar.

Being organized for the benefit of enterprise and validation professionals such as validation engineer, validation project manager or software quality engineer, and IT Managers, Directors, VPs, Chief Information Officers, Quality Assurance/Quality Control Managers, Validation Engineers, Validation Project Managers and Program/Project Managers; this webinar will cover the following areas:

o  The Cyber Threat Megatrends: What You Need to Know for Validated Systems

o  Understanding Cybersecurity Regulatory Guidance and Standards

o  Cybersecurity Qualification: The NEXT Frontier

o  Automated Testing in the Cloud

o  Top 20 Critical Security Controls for Validated Systems

o  Cloud Security Technology Maturity

o  Cloud Quality Assurance & Governance

o  The Changing State of Computer Systems Validation in a Cyber World

o  Understanding the NIST Cybersecurity Framework for Validated Systems.

Here to continue further How to mitigate and protect validated systems

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What Should be Included in a Calibration Program

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.

Given this fact, it is important for professionals who work in laboratories to ensure that the laboratory has an instrument calibration program that assures that the instruments are calibrated at appropriate intervals using specific procedures that define the standards and tolerances that are relevant to and appropriate for the intended use of the instrument.

A well-structured learning session on calibration in the laboratory

All the core and supplementary aspects of laboratory calibration will be taught at a highly valuable learning session that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

At this webinar, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To gain complete understanding of all the important aspects of laboratory instrument qualification, please enroll for this webinar by visiting What Should be Included in a Calibration Program

Imparting understanding of the standards

The speaker at this webinar will show to participants how to apply measurement uncertainty or test accuracy ratio to specific calibration procedures, as well as the selection of standards needed to provide scientifically sound calibrations traceable to national references.

Building on the terminology found in 21CFR160 (b) (4); Jerry will base his teaching by relating and applying the concepts discussed to specific key instruments found in the testing laboratory. This learning will improve participants’ understanding of calibration and help them understand the ways by which to apply these concepts.

Jerry will cover the following areas at this session:

o  The regulatory and technical requirements for calibration.

o  What should be included in a calibration program

o  The importance of a data-based calibration interval and limits of accuracy and precision

o  The impact of measurement uncertainty when establishing limits of accuracy

o  The classification of test instruments

o  Current practices in the calibration of specific instruments

Laboratory Managers, Laboratory Supervisors, Laboratory Analysts that are responsible for the calibration of laboratory instruments, Laboratory Record Reviewers, Quality Assurance record reviewers and Quality Assurance Managers will gain important learning from this webinar.

Many UK SMBs don’t invest in security solutions

A third of UK small businesses are risking their online safety by operating at or below the “security poverty line,” according to new research from Duo Security.

The cybersecurity company partnered with YouGov to survey 1,0009 senior decision makers across the UK to determine how much they are spending on cybersecurity and whether government initiatives such as Cyber Essentials and Cyber Risk Aware have been effective at protecting SMBs from cyber threats.

The survey found that 38 percent of small businesses had spent nothing at all to protect themselves from cybersecurity threats this year and 30 percent of respondents said that less than three percent of their overall budget was allocated for cybersecurity.

Duo Security’s survey also revealed that 36 percent of UK small businesses are operating at or below the security poverty line and are close to being unable to effectively protect their organization from cybersecurity threats. Despite this though, 45 percent of those surveyed do not consider themselves to be possible targets for hackers.

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Artificial intelligence set to revolutionise future occupational health delivery

“Technology will replace many doctors, and other professions.” This headline caught my eye in October 2016 when I was preparing a presentation for the Medgate UK annual conference.

The article, from the Harvard Business Review (Susskind R and Susskind D, 2016), has become my wake-up call. It states that faced with the claim that artificial intelligence (AI) and robots are poised to replace most of today’s workforce, most mainstream professionals — doctors, lawyers, accountants, and so on — believe they will emerge largely unscathed.

But the research and analysis challenges the idea that these professionals will be spared. The researchers expect that within decades, the traditional professions will be dismantled, with most professionals replaced by fewer expert people, new types of experts, and high-performing systems.

My initial reaction was “not on my watch”. Having worked within the field of OH since 1993, I have seen, and been part of, many paradigm shifts.

I began my career as a factory nurse and studied at the Royal College of Nursing when the Occupational Health Certificate was a non-English National Board approved course (the ENB was subsequently replaced by the Nursing and Midwifery Council). I then acquired an occupational health Master’s degree and a Master of Business Administration (MBA).

The key factor behind all the change I have seen and innovations I have implemented has been the use of technology to reduce the effort required to complete

high-volume tasks. This has involved deconstructing some of the traditional ways of working, and challenging statements such as: “Only qualified occupational health advisers [OHAs]/physicians can perform/undertake that task.”

What is artificial intelligence?

AI is an umbrella term for a group of technologies – including machine learning – that enable computers to learn new skills and capabilities based on the data they are exposed to.

Machine learning started making its way into industry in the early 1990s. It began with relatively simple tasks, such as assessing credit risk from loan applications, and sorting the mail by reading handwritten characters from post codes. In recent years there have been many dramatic breakthroughs. Machine learning is now capable of far more complex tasks.

In 2012, the Kaggle data science platform challenged its community to build an algorithm that could grade high-school essays (Goldbloom, 2016). The winning algorithms were able to match the grades given by real teachers.

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How they take on water and therefore on how they react in the process

For any product that is being produced using the extrusion process; raw materials and their characteristics are the most important variable.

Grasp of why things happen as they do in the process and why the process and product being produced react as they do, can come about only when there is a basic understanding of the raw materials and how they flow, cook and potentially over-process.

Since different types of ingredients have different properties; each ingredient reacts very differently during the process and as the product’s defining characteristics are produced. For example, both starches and proteins undergo fundamental transformations during processing, but those transformations are very different from one another.

What complicates matters further is that most ingredients used in the process are a combination of the fundamental components (carbohydrates, protein, fat, etc.). So, all components are processing at the same time and undergoing a complex combination of transformations.

Insights into how raw material work in food extrusion

A fundamental understanding of the raw materials that are used, and their properties, is essential to knowing how to select raw materials during the product development phase as well as understanding how changes in raw materials are contributing to processing difficulties during production.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer understanding of these matters relating to raw materials for food extrusion processing.

Dr. Brad Strahm, who is a Principal with the XIM Group, LLC, a firm providing consulting services in the area of product development, process engineering, troubleshooting equipment engineering, and project management; will be the speaker at this webinar. to know more about this area from this expert, please register for this webinar by visiting Food Extrusion Processing

Discussion of raw materials used in extrusion

Dr. Strahm will offer fundamental food-science information about the raw materials that are typically used in the extrusion process of food products. The material covered will include information covering the structure, characteristics and cooking of carbohydrates, proteins, fats, and other additives important to the food extrusion cooking process.

Dr. Strahm will talk extensively about carbohydrates, which will include extensive information about starches – the most common component in extruded food products. Other aspects such as structure, cooking requirements, selection based on flavor, appearance and texture will also be explained. The speaker will also explain other carbohydrates such as fiber and sugar and their impact on the extrusion process and on developing the functional aspects of the extruded food product.

Proteins and fats

Proteins are also very important in extruded food products, even though they react very differently and their structure is very different from that of carbohydrates. Proteins play an important role in meat analog products as well as in protein enriched foods that are popular today.

The speaker will also talk about fats, which are also an important component in extruded products and have a large lubricating effect on the process. Fats also have an important energy-dense role to play in food products. The particle size of the raw materials plays an important role in how they take on water and therefore on how they react in the process. In this discussion, Dr. Strahm will talk about particle size as well as particle size distribution and its impact on efficiently producing quality product.

Many additives that are often used in extruded products that have a large impact on the process and on the product produced will be discussed. The speaker will share a few tricks of the trade for modifying cell structure and texture with the participants.

In this webinar, which will be of high value and usefulness to professionals associated with food processing and cooking, such as Product Developers, Production Managers, Production Operators, Quality Assurance Technicians, Purchasing Agents and Maintenance Personnel; Dr. Strahm will cover the following areas:

o  Carbohydrates: starch, fiber, sugars

o  Proteins: plant and animal sources

o  Fats

o  Additives

o  Importance of particle size.

15 ways to stay healthy in college

With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.

Health-sayings-stay-happy-stay-healthy

Some freshmen even might worry about the “freshman 15,” a.k.a. the weight gain that can happen when freshmen come to college. Tanya Bachman, nutrition instructor in the School of Nursing, said weight gain and unhealthy eating habits are common in college.

“I think it’s very common, not every single person is going to experience it but it is common,” Bachman said. “It’s being away from home and learning how to feed yourself, at the same time balancing academic load.”

Whether or not you believe in the freshman 15, everyone can agree that staying healthy in college is hard — both mentally healthy and physically healthy. The Beacon put together a list of 15 ways to stay healthy this semester.

1. Watch what you’re eating

2. Don’t skip meals

3. Avoid unhealthy snacking

4. Avoid sugary coffee drinks

5. Stay hydrated

6. Take vitamins

7. Use the Beauchamp Center

8. Take a fitness class

9. Try yoga and meditation

10. Get active with your friends

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Who are involved in filing investigational new drug applications

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use of analytical methods for drug quantification at many stages of drug development process grows in prevalence; the need for scientists, technicians, and quality assurance personnel, etc. to understand the complete validation process of the analytical method has become all the more important and necessary.

The validation of a method used is all the more important when it comes to dealing with quantitative analysis of drugs in various biological matrices such as blood, serum, plasma, cerebrospinal fluid, urine, tissues, etc. Yet, many companies overlook these crucial aspects of validation that are outlined in FDA’s guidance, and end up receiving citations from this regulatory agency for these reasons. A company which receives these citations not only faces the prospect of delayed drug development; it can also dent and jeopardize the future of the drug’s regulatory acceptance.

Clear understanding of FDA guidelines for bioanalytical method development and validation

A complete and clear understanding of the FDA guidelines for bioanalytical method development and validation is necessary to avoid being in situations outlined here. It is to familiarize pharmaceutical professionals with this important aspect of the FDA guidelines for bioanalytical method development and validation that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.

Venkata Kashyap Yellepeddi, who is an Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences, Utah and Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Utah; will be the speaker at this webinar. Please register for this webinar by visiting FDA guidelines for Bioanalytical

This webinar will offer intensive and detailed understanding of the bioanalytical method development and validation for drugs and nutraceuticals outlined in the FDA’s guidance. This learning will add immense value to sponsors and analysts representing industries who are involved in filing any of the following:

o  Investigational new drug applications (INDs)

o  New drug applications (NDAs)

o  Abbreviated new drug applications (ANDAs)

o  Biologic license applications (BLAs)

o  Supplements in developing bioanalytical method validation information used in human clinical pharmacology

o  Bioavailability (BA)

o  Bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation

Analysts involved in bioanalytical methods used for nonclinical pharmacology/toxicology studies and for the veterinary drug approval process will also find this webinar highly valuable.

Matching the FDA’s level of expectations

The FDA expects anyone involved in quantification of drug using an analytical method in any stage of the drug development to be well-versed with FDA’s guidance for bioanalytical method validation. With this assumption, FDA inspectors often ask questions on analytical method validation during routine inspections, and expect all personnel involved to be knowledgeable about the process of validation. This webinar will familiarize participants with these aspects of an FDA inspection.

Kash will cover the following specific areas during this webinar:

o  Chromatographic Methods

o  Ligand Binding Assays

o  Parameters involved in Bioanalytical Method Validation

o  Data Analysis, Statistics and Reporting

o  Additional issues in Bioanalytical Method Validation.

This course is of high value to those involved in one or another way with bioanalytical method development and validation, such as Chromatographers, Analysts, Chemists, Scientists, Formulators, Patent Lawyers, Technicians in Pharmaceutical and Veterinary Industry, and Contract Research Representatives.