Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.

GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend supporting applications for research or marketing permits for certain classes of products. These include:

• Food and color additives
• Human and animal drugs
• Medical devices for human use
• Biological products and electronic products that are regulated by the FDA.

Joy McElroy, Principal Consultant at Maynard Consulting Company, will, at a marathon four-hour session being organized on March 25 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, explain all the aspects of GLP while giving clarity on how it differs from GMP.

Please visit globalcompliancepanel to register for this important learning, at which the following areas will be covered:

• What are Good Laboratory Practices
• Why were they created
• What is the objective of GLPs and how are they associated with GMPs and SOPs
• Statistical Procedures for data Evaluation
• Instrumentation Validation
• Analytical and laboratory Certification
• Documentation and Maintenance of Records
• Consequences of Noncompliance
• Disqualification and Reinstatement

This webinar is being organized for the benefit of personnel that deal with GLP and GMP in the course of their work, and include Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel, and Auditors.

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About the expert:

With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

Growth and Forecasting for next Upcoming Year Until 2025

Artificial Intelligence in Diabetes Management Market 2019 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. The Market report offers noteworthy data regarding industry’s growth parameters, the current state of the market in terms of analysis of possible economic situations and macroeconomic analysis. This report features competitive scenarios from the recent technology and provides a comprehensive analysis of key growth strategies adopted by key players.

The report has been accumulated through meticulous primary and secondary research, which encompasses interviews, inspections, and observations of experienced analysts, as well as proven paid sources, news articles, annual reports, trade journals, and company body databases. The study also presents a qualitative and quantitative evaluation by analyzing the data collected from industry professionals and market participants across crucial factors in the industry’s value chain. These segments are studied in detail for the market estimates and forecasts at regional and country level.

This report focuses on the Artificial Intelligence in Diabetes Management Market outlook, future outlook, growth opportunities and core and core contacts. The purpose of the study is to present market developments in the US, Europe and other countries. It also analyzes industrial development trends and marketing channels. Industry analysis was conducted to investigate the impact of various factors and to understand the overall appeal of the industry.

Reasons for buying this report:

• It offers an analysis of changing competitive scenario.
• For making informed decisions in the businesses, it offers analytical data with strategic planning methodologies.
• It offers a seven-year assessment of the Global Artificial Intelligence in Diabetes Management Market.
• It helps in understanding the major key product segments.
• Researchers throw light on the dynamics of the market such as drivers, restraints, trends, and opportunities.
• It offers a regional analysis of the Global Artificial Intelligence in Diabetes Management Market along with the business profiles of several stakeholders.
• It offers massive data about trending factors that will influence the progress of the Global Artificial Intelligence in Diabetes Management Market.

A detailed outline of the Global Artificial Intelligence in Diabetes Management Market includes a comprehensive analysis of different verticals of businesses. North America, Latin America, Asia-Pacific, Africa, and Europe have been considered for the studies on the basis of several terminologies.

To know more https://tinyurl.com/ye572xqv

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The FDA has set out requirements for validating all computer systems that handle data regulated by it. These should be in accordance with its guidance on computerized systems, first issued in 1983. The main points of this guidance continue to be consistent today, even with all the changes that technological developments have brought in.

The 1990’s was a decade in which this guidance was revisited for its relevance to the medical device industry. This was because the first issuance was limited to pharmaceuticals.  In 1997, in the context of the move of many FDA-regulated organizations to move into a paperless environment, the FDA issued 21 CFR Part 11, which sought to address electronic records and signatures.

A few changes, such as discretionary enforcement measures, have been brought into this guidance from then, to fashion it to the needs of the industry. Yet, this issuance is rather confusing, although it was intended to help the industry avoid creating a huge regulatory compliance cost, which was the main reason for which many companies were reluctant to adapt the technology.

What are the current trends in compliance and FDA enforcement?  Technology is a major basis for these trends, although there are other that are based on economics, social media, new diseases, politics, and many other influences.

All these will be discussed in detail at a six-hour learning session from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance.  Carolyn Troiano, a senior compliance professional who has worked in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the expert at this webinar, which is being organized on October 28.

Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-trends-for-computer-system-validation-(csv)-compliance-and-enforcement-10310LIVE to enroll for this valuable learning.

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Everything that is required to protect the validity of data that is regulated by the FDA and is stored in electronic format in computer systems will be explained at this webinar. The expert will describe the ways by which to properly validate an FDA-regulated computer system so that security is ensured and data integrity objectives are met.

It is accepted that implementation and adaptation of the System Development Life Cycle (SDLC) methodology is the ideal approach for Computer System Validation (CSV) and for maintaining the system in a validated state throughout its life. Carolyn will explain this aspect in detail at this webinar.

She will also discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

The following areas will be explained at this webinar:

Session 1 (90 Mins):

• FDA Regulatory Oversight
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology

Session 2 (90 Mins):

• GAMP 5 Software Categorization
• System Risk Assessment

Session 3 (90 Mins):

• Requirements
• Design
• Testing
• Requirements Traceability Matrix (RTM)
• Additional Validation Documentation

Session 4 (90 Mins):

• FDA Inspection Trends
• Regulatory Influences
• Response to Change

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About the speaker: During the over 35 years she has served in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, Carolyn Troiano has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and also collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

To understand AI advancements in health care, there are two storylines we must follow

If ever there were an industry that could reap the benefits of AI, it is healthcare. The adoption of this technology to actually make medicine better is obvious. However, with this adoption comes a slew of ethical issues.

Let’s start with some numbers: In 2018, the US spent $3.65 trillion on healthcare. That works out to $11,121 per capita, a 4.4% increase over 2017. In addition:

• Spending on hospitals, doctors, and other clinic services was $2.16 trillion, holding steady at 59% of total health care spending.
• The spending category that experienced the most substantial year-over-year increase was the general cost of administering health insurance, which rose 7.7% in 2018.
• Spending on prescription drugs purchased in retail pharmacies went up 3.3% in 2018, higher than the 0.4% rate in 2017.
• A majority of the more significant spending totals were due to higher overall prices, while the “use and intensity” of health care services played a smaller role.

The per capita spend in western economies, other than Switzerland, which was about 80%, was 50% or less. The worse news is that the US has slipped to 36th in the world in quality of healthcare. (The above data is from Centers for Medicare & Medicaid Services and CIA World FactBook.)

Another lesser-known statistic is the magnitude of iatrogenic disease. From Wikipedia: an iatrogenic disorder occurs when the deleterious effects of the therapeutic or diagnostic regimen causes pathology independent of the condition for which the regimen is advised.

In other words, they are harmed by medical practice. According to a Johns Hopkins study, 251,454 deaths stemmed from a medical error – making it the third leading cause of death in the US, just behind cancer and heart disease.

All industries are facing the problem of which areas to apply AI. In an article in Healthcare IT News, some advice for the healthcare industry was: while AI may have the potential to discover new treatment methods, the report finds strongly entrenched ‘ways of working’ in the healthcare industry that are resistant to change. The authors warn that ‘simply adding AI applications to a fragmented system will not create sustainable change.’ Good advice for any industry.

To continue this: http://bit.ly/2lUwsZj

Robotic surgeons set to spark ‘revolution in healthcare’

Specialists working on patients while controlling automated arms could turn into another standard in medical clinics.

The help of robots in careful rooms are anticipated to change the manner in which activities are performed by enabling medical procedures to be done as keyhole techniques.

As the utilization of mechanical medical procedure turns out to be progressively well known, an expanding number of surgeons are being prepared in how to utilize them. They enable specialists to perform complex strategies utilizing an insignificantly obtrusive methodology.

Expert colorectal specialist Jonathan Morton is among a bunch of doctors who have evaluated the hardware.

He said: “It’s quite exciting to see robotic techniques rolled out – from an ergonomic point of view, the system is set up better so that the stresses on the body are less, reducing injury rates for surgeons.

“It’s not actually the robot doing the surgery – it’s the surgeon with the experience and the knowledge telling the robot what to do, effectively it’s the same as keyhole surgery with robotics.”

The robots have four flexible joints like a human arm and are controlled by a surgeon using a joystick and a 3D screen. The technology is capable of carrying out a wide range of tasks.

CMR Surgical, the company behind the robot, claims the technology will revolutionise healthcare.

The firm’s chief medical officer, Mark Slack, said: “The vision we have is that we have built a system to enable many more patients to get MAS (minimal access surgery) and all the benefits that that brings for them – like reduced complications, reduced pain – and the aim is to put these in as many hospitals as we can.”

The NHS is developing a £50m framework for robotic surgical equipment, soon to be rolled out across the country.

So does the future of surgical procedures rest in non-human hands?

Richard Kerr, of The Royal College of Surgeons (RCS), believes it’s poised to change the nature of surgery forever.

“The robots are not going to be taking over what surgeons do. They will become an integral part of the tools surgeon use to carryout operations on their patients,” he said.

“Maybe in the long-distance future some aspects of surgery may potentially be delivered by robots.”

The RCS says a majority of NHS trusts have guidelines which surgeons are expected to follow when using robotics

More at https://news.sky.com/story/robotic-surgeons-set-to-spark-revolution-in-healthcare-11810158

The Next Few Things To Immediately Do About Hipaa Training for Compliance Officer

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do’s and don’ts with HIPAA -I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations
I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK!

In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).

Why you need to know 

Do you have an affective HIPAA compliance program?  Do you know what needs to be done to satisfy the requirements?
New laws, funding, and enforcement mean increased risk for both business associates and covered entities – 2017 was a record year for enforcement and fines – 2018 will be no different.

HIPAA Omnibus – Do you know what’s involved and what you need to do?

What does Omnibus mean for covered entities and business associates?

Why should you be concerned?

Court cases that are changing the landscape of HIPAA and patient’s ability to sue!

TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates.  You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT or internal administrative practices.

About the Intructor 

Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions). Almost all of Brian’s clients are earned by referral with little or no advertising. Brian is well known and highly regarded in medical circles throughout the United States .

For more to continue reading

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

To compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

• What are Good Laboratory Practices
• Why were they created
• What is the objective of GLPs and how are they associated with GMPs and SOPs
• Statistical procedures for data evaluation
• Instrumentation validation
• Analytical and laboratory certification
• Documentation and maintenance of records
• Consequences of noncompliance
• Disqualification and reinstatement

Who will be benefited by this

• Quality Assurance Personnel
• Quality Control Personnel
• Research and Development Personnel
• Regulatory Affairs Personnel
• Project Managers
• Manufacturing Managers
• Validation Engineers
• Internal Auditing Personnel
• Microbiology Personnel
• Auditors

Instructor Joy McElroy With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.

The SDLC approach takes all aspects of validation into account throughout the life of the system and protects the data that it houses through its retention period.  The data is a key asset for any FDA-regulated company and must be protected.  If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated.  This could result in a devastating loss to any company’s bottom line.

We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

The guidance was revisited for its application to the medical device industry in the 1990s, as the first issuance addressed pharmaceuticals only.  In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment.

This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures, but still remains somewhat confusing.  The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance and FDA enforcement.  Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.  Others are based on factors including economics, social media, new diseases, politics, and a host of other influences.

Instructor:

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

• Information Technology Analysts
• Information Technology Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists

Here to go in details

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why should you attend : Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

Areas Covered in the Session

• Applicable and relevant regulations in EU, Canada and US
• Definitions
• Medical device adverse event reporting requirements in EU, Canada and US.
• Medical device vigilance system during the post-production phase in EU.
• Mandatory medical device problem reporting requirements in Canada.
• Mandatory medical device reporting requirements in US.
• Review of actual reporting forms in EU, Canada and US
• Applicable and relevant guidance documents
• Conclusion

Who Will Benefit:

• Regulatory Affairs Managers, Directors and VPs
• Clinical Affairs Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Compliance Managers and Directors
• Sales and Marketing Managers, Directors, and VPs
• Complaint Handling and Risk Management Managers and Directors
• Site Managers, Directors, and Consultants
• Senior and Executive Management
• Compliance Officers and Legal Counsel
• Business Development Managers, Directors, and VPs

Click Here to Continue Learning

Effective Technical Writing in the Life Sciences

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.

Gathering the information to be included in the technical document requires collaboration between the writer and the various subject matter experts that possess the knowledge to be harvested. How that information is gathered can be an effective efficient process or an ineffective time-consuming endeavor all dependent upon the techniques employed to execute the activity. We will address the most effective techniques for extracting information from SMEs as well as those techniques that work best when observing procedures and activities to be documented.

Why you have to know

->Even with the advent of technology, we still communicate with the written word. Technical writing is about conveying information quickly, accurately, clearly, and succinctly. How we communicate, how we are understood, and how the message is received directly depends upon our skills as technical writers. In the life sciences, this skill is exceedingly important.

->In the life sciences, the stakes are high in terms of the writing’s ability to enable 100% accurate understanding of the content and where applicable, performance of the task or procedure documented. In the life sciences, that could mean the difference between life or death, safety or injury, loss or recovery, contamination or purity, success or failure.

->Unfortunately, technical writing is not a skill that is given much emphasis in college curriculums if any. Technical writing is a skill, life sciences workers are assumed to have and are expected to demonstrate at a level of skill usually beyond the capability of most. Unfortunately, most readers of technical writing are in the “same boat.” They “don’t know a good one when they see one.”  At the end of the day, in most cases, you have mediocre writing at best that may or may not convey the message intended.

->This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents for the life sciences will be addressed with the goal of helping you become better technical writers. The tips and skills presented can be applied immediately and will be evident in the very first document that you write after this virtual seminar.

Writing technical material to include http://bit.ly/2SFohvo_Technical