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

The common thread running through Topol’s books is that medicine is a mess and technology will save it.

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.

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A Systematic Approach to Implementing Statistical Methodologies

Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the ‘process design stage through commercial production’ into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, “A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Manufactures should:

  • Understand the sources of variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product.”

The second stage of process validation is process qualification. Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ “combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches.” Additionally, the process validation guidance document that “Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.”

The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: “After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.” Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2.”

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

Areas covered by the Instructor:

  • Apply statistics to set specifications and validate measurement systems (assays)
  • Develop appropriate sample plans based on confidence and power
  • Implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Who will benefit by this:

  • Process Scientist/Engineer
  • Design Engineer
  • Product Development Engineer
  • Regulatory/Compliance Professional
  • Design Controls Engineer
  • Six Sigma Green Belt
  • Six Sigma Black Belt
  • Continuous Improvement Manager

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Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices. 

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls.  With very few exceptions, device recalls by companies are voluntary.

There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.

Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years.  We will take the time to interact though the day to navigate all aspect of the recall process

This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance.  Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas covered by the Instructor:

Determine what actions are taken in a medical device recall

  • Cite the regulatory requirements for recalls/ field actions regarding medical devices
  • Reference and use medical device recall authority and guidance documents
  • Identify and understand the applicable regulatory standards and guidance documents
  • Identify the different recall types and classifications
  • Explain what types of communications are required
  • Define what effectiveness checks are
  • Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA’s handling of MDR reports
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Effective Technical Writing in the Life Sciences

The tips and abilities exhibited can be connected quickly and will be clear in the absolute first archive that you compose after this virtual course.

In the wake of setting the phase for this substance, we dive into the composition procedure starting with the group of spectators and how the crowd must be dissected to decide the dimension of composing that must be utilized to finish the report.

Social occasion the data to be incorporated into the specialized report requires coordinated effort between the essayist and the different topic specialists that have the learning to be reaped. How that data is accumulated can be a successful productive procedure or an insufficient tedious undertaking all ward upon the strategies utilized to execute the action.

We will address the best systems for removing data from SMEs just as those methods that work best when watching methodology and exercises to be recorded.

Why You have to know

Indeed, even with the approach of innovation, despite everything we speak with the composed word.  Technical composing is tied in with passing on data rapidly, precisely, plainly, and succinctly.  How we impart, how we are comprehended, and how the message is gotten legitimately relies on our aptitudes as specialized writers.  In the existence sciences, this ability is exceedingly significant.

In the existence sciences, a lot is on the line as far as the composition’s capacity to empower 100% precise comprehension of the substance and where appropriate, execution of the undertaking or system documented.  In the existence sciences, that could mean the contrast between crucial, security or damage, misfortune or recuperation, tainting or virtue, achievement or disappointment.

Shockingly, specialized composing isn’t an expertise that is given much accentuation in school educational plans if any.  Technical composing is an ability, life sciences laborers are accepted to have and are relied upon to exhibit at a dimension of aptitude more often than not past the capacity of most.  Unfortunately, most perusers of specialized composing are in the “same boat.”  They “don’t have a clue about a decent one when they see one.” At the day’s end, by and large, you have fair composition, best case scenario that could possibly pass on the message planned.

This virtual workshop will walk you through the specialized composition process from begin to finish.  Each basic part of composing specialized reports for the existence sciences will be tended to with the objective of helping you become better specialized writers.  The tips and abilities exhibited can be connected quickly and will be clear in the absolute first archive that you compose after this virtual course.

  • What is technical writing, and what role does technical writing play in the life sciences?
  • Technical writers in the life sciences – what do they write – types of medium
  • Analyzing the audience
  • Analyzing the information – working with Subject Matter Experts
  • Planning the content
  • Formats, consistency and styles
  • Non-native audience considerations
  • Grammar, spelling, punctuation, numbers and symbols
  • Simplify your writing
  • Ensuring accuracy

By the Instructor Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

eCTD Submissions of IND/NDA to the US FDA, EU and Canada

It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. 

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Those who are benefited by this

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Anyone responsible for providing content for the CTD

Instructor:

Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

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

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An understanding of Risk Management and Analysis for Medical Device Manufacturers

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Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send the product, and with it, the reputation of the manufacturer and even the healthcare provider, into a tailspin.

From its beginnings a few decades ago as a “nice to have” feature or discipline that used to come into the picture only when there were issues; quality has grown into an indispensable element of a medical device product. A medical device product into which quality does not get intertwined at every stage, right from procurement of the raw material to the use it is put to by the consumer and beyond, is unthinkable today.

risk-management-and-analysis-for-medical-device--manufacturersThe primary driver of this metamorphosis is risk management. Risk management and analysis for medical device manufacturers has been the lynchpin among the agents of change brought about into this field. Quality has evolved as a result of the change in the import regime in the US in the seventies, when products from around the world used to deluge the US market.

the consequences of this trade policy have led to the emergence of the creation of quality approaches such as Six Sigma and kaizen among many others, and global standards, of which ISO 14971 specifically relates to Quality Management Systems and methods for medical devices. Root Cause Analysis is at the root of each of these methodologies and standards.

So, what is risk management and analysis for medical device manufacturers?

risk-management-and-analysis-for-medical-device--manufacturersIn the context of medical devices, risk management and analysis for medical device manufacturers means applying a set of processes, policies, methods and practices into their manufacturing systems in alignment with respective and relevant standards as set out by global standards such as the ISO. The aim of these standards and practices is to analyze, assess, control and monitor risk. The ISO 14971 has been revised many times and each time this is done, the latest one becomes the extant version. This and other standards and practices prescribe steps and processes that need to be implemented at all stages of the product lifecycle.

The need for risk management and analysis for medical device manufacturersThe need for risk management and analysis for medical device manufacturers is simple: To ensure that the medical device meets quality requirements and is manufactured according to standards and specifications and methods prescribed in these standards. Standards such as ISO 13485, various Quality Systems Regulations (QSRs) such as 21 CFR 820 and a few European standards work in tandem with ISO 14971. The core purpose of requiring medical devices manufacturers to meet these requirements is to ensure that safety and quality are built into a medical device from start to finish.

The time at which to carry out risk management and analysis for medical device manufacturers

risk-management-and-analysis-for-medical-device--manufacturersRisk management and analysis for medical device manufacturers is to be carried throughout the lifecycle of the medical device. A set purpose is set out at each stage of the manufacturing process. For example, medical device manufacturers are required to identify and eliminate potential hazards at the initial stage using the concepts of product optimization, and use the principles of risk elimination at all the next stages, and to use the methods prescribed during a product recall.

The ways of carrying out risk management and analysis for medical device manufacturersThe ways by which risk management and analysis for medical device manufacturers are to be exercised form an important part of quality. The ISO 14971 standard is pretty flexible in this regard, allowing the manufacturer to adapt any existing standard or approach that he thinks is best suited for his organization.

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