LIFE SCIENCE TRAINING TRENDS & THOUGHT LEADERSHIP

QbD: A Framework For Improved Decision Making Throughout Drug Development
QbD: A Framework For Improved Decision Making Throughout Drug Development

A frequent complaint of process engineers tasked with implementing quality by design (QbD) is the lack of information provided by their upstream development teams. For QbD to be  implemented efficiently, at least 80% of the knowledge needed for process development must be generated in the R&D phase and transferred downstream.

GUEST COLUMNS

  • 4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)
    4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

    After countless hours putting together your 510(k) submission, the last thing you  expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.

  • What Is Continuous Manufacturing, Anyway? Agreeing On A (Proper) Definition
    What Is Continuous Manufacturing, Anyway? Agreeing On A (Proper) Definition

    In the past 10 years, continuous manufacturing (CM) has gone from theoretical discussion to manufacturing reality. However, the pharmaceutical industry has not yet explicitly defined the term “continuous manufacturing,” nor has it ensured that the term’s usage is aligned with other industries.

  • The 5 Basic Tenets Of Data Integrity — And How Failures Occur
    The 5 Basic Tenets Of Data Integrity — And How Failures Occur

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

  • Training Effectiveness – A Quality By Design Approach
    Training Effectiveness – A Quality By Design Approach

    Training effectiveness seems to be a topic that is percolating, especially in GMP environments. Yet, it’s shrouded in mystery. No one is clear on what it is, how to implement it, and what the regulators are looking for when it comes to effective training.

  • FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown
    FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown

    3D printing of medical devices will revolutionize and disrupt healthcare as we know it. The U.S. Food and Drug Administration (FDA) has already cleared more than 80 medical devices and one prescription drug that are produced by 3D printing techniques.

  • Human Error: How To (Accurately) Identify & Address It Using Performance Models
    Human Error: How To (Accurately) Identify & Address It Using Performance Models

    After giving a recent course on reacting to human error, one of the attendees sent me a variety of questions about how to apply the human performance models we discussed in FDA-regulated environments.

  • Applying Human Performance Models In FDA-Regulated Environments
    Applying Human Performance Models In FDA-Regulated Environments

    This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.

  • Examining CAPAs' Role As A Critical Medtech Management Tool
    Examining CAPAs' Role As A Critical Medtech Management Tool

    A CAPA system collects process information across the organization and provides cross-functional intelligence to identify when, why, and where potential compliance issues are occurring. This information, when systematically collected and rigorously analyzed, is a critical element of effective management control of an organization. 

  • QbD: A Framework For Improved Decision Making Throughout Drug Development
    QbD: A Framework For Improved Decision Making Throughout Drug Development

    A frequent complaint of process engineers tasked with implementing quality by design (QbD) is the lack of information provided by their upstream development teams. For QbD to be  implemented efficiently, at least 80% of the knowledge needed for process development must be generated in the R&D phase and transferred downstream.

  • Power Up Your GMP Training: How To Make It More Relevant, Meaningful, & Engaging
    Power Up Your GMP Training: How To Make It More Relevant, Meaningful, & Engaging

    A few months ago, I contributed an article on making GMP training more practical.  In this article, we’ll expand on the topic and look at making GMP training more engaging and meaningful — to benefit both the business and its personnel. 

More Guest Columns

HUMAN ERROR: WHAT PHARMA SHOULD KNOW AND DO ABOUT IT

  • Human Error: What Pharma Should Know And Do About It — Part One
    Human Error: What Pharma Should Know And Do About It — Part One

    When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part one of this four-part series, Gallant discusses where the industry currently stands in identifying the root cause of a problem, as well as the extent to which industry turns to human errors as an explanation.

  • Human Error: What Pharma Should Know And Do About It — Part Two
    Human Error: What Pharma Should Know And Do About It — Part Two

    In part two of this four-part series, Gallant defines the types of human error that can interfere with daily operations and some of the reasons these incidents are likely to occur. Gallant also provides some best practices that should be undertaken to stop human error before it occurs.

  • Human Error: What Pharma Should Know And Do About It — Part Three
    Human Error: What Pharma Should Know And Do About It — Part Three

    In part three of this four-part series, Gallant discusses the underlying role management can play in contributing to human error and why the industry is less prone to identify management as a root cause of a problem.

  • Human Error: What Pharma Should Know And Do About It — Part Four
    Human Error: What Pharma Should Know And Do About It — Part Four

    When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. In the final part of this four-part series, Gallant describes some of the ways industry is contributing to or causing human error. 

INDUSTRY ARTICLES

  • Accelovance Addresses CRA Shortage With Accelovance Academy Inaugural Graduation Class

    Accelovance, Inc. (Accelovance), a global contract research organization (CRO) focusing in vaccines, oncology, and general medicine clinical research held a graduation ceremony yesterday for Accelovance Academy's inaugural class of Clinical Research Associates (CRAs).

  • Merck Changes The Paradigm On Clinical Trials
    Merck Changes The Paradigm On Clinical Trials

    Patient centricity remains a hot topic in the clinical space, and generated a significant amount of discussion at the CROWN Congress in Philadelphia earlier this year. Few would argue this will be a critical factor in turning around patient perceptions of the pharma industry, and hopefully solve the patient recruitment and retention issues that have long plagued the industry.

  • Pitch Perfect Minority Patient Recruitment
    Pitch Perfect Minority Patient Recruitment

    Beyond securing more critical study volunteers across the board, the hot-button issue continuing to plague Big Pharma and clinical research (the industry) is how to get more minorities to participate in clinical trials.

  • FDA And NIH Release Draft Clinical Trial Protocol Template
    FDA And NIH Release Draft Clinical Trial Protocol Template

    The FDA and NIH are requesting public comment on a draft clinical trial protocol template that has been released for Phase 2 and Phase 3 IND (investigational new drug)/ (investigational device exemption) studies. The template contains instructional and sample text for NIH funded investigators to use when writing protocols. 

  • GxP Track: Bringing New Faces to the LTEN Annual Conference
    GxP Track: Bringing New Faces to the LTEN Annual Conference

    If you have looked at this year’s 45th LTEN Annual Conference agenda, you may have been surprised to see a new training track designed for GxP, quality, R&D, medical affairs, regulatory and manufacturing trainers.

  • Focus on Performance Innovation

    Far too often, I see learning organizations make the same mistake. They see a new trend or piece of technology and focus on figuring out how to make it fit. We want to impress our stakeholders and demonstrate the value of our organizations. Unfortunately, it often has the opposite effect.

  • Are Patient Surveys The Missing Link To Successful Recruitment & Retention?

    While patient recruitment and retention have been an issue in the delay and expense of clinical trials for decades, patient centricity has at least temporarily moved to the forefront in the clinical space. Although often discussed as two separate issues, there is no question the two are intertwined. Integrating the patient voice in the protocol design process will certainly lead to better recruitment outcomes and patients who are more willing and able to adhere with a study for its duration.

  • How To Increase Patient Enrollment By 600 Percent

    The process of getting patients to engage in a clinical trial is a headache that will keep many recruitment specialists awake at night. The Cancer Research Institute notes only two to three percent of oncology patients who are eligible for a clinical trial actually participate. Many are not even aware that trials are an option for them. More importantly, 95 percent of cancer patients might be missing out on a potentially lifesaving new treatment.

  • Survey Says: Technology Use In Clinical Trials Continues To Grow

    How pervasive is the adoption of new technologies in clinical trials? DrugDev recently surveyed 572 clinical trial investigators from 11 countries to try and answer that very question. Their results are good news for technology vendors, clinical personnel hoping for greater efficiencies provided by emerging technologies, and sponsors hoping to cut the time and cost of trials.

  • Should A Clinical Mastermind Run The FDA?

    We all know that a primary driver of the high cost of drug development is clinical trials. The process is not only costly, but lengthy and difficult. And even once you complete the four phases and submit your data to the FDA, there is no guarantee the drug will be approved. All this might make you wonder: Could the drug development process be made easier if we had a clinical researcher at the helm of the FDA? You may not need to wonder much longer.

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ABOUT LIFE SCIENCE TRAINING INSTITUTE

Customized Pharmaceutical Training For Your Staff

The Life Science Training Institute (LSTI) offers a full suite of biotech, medical device, and pharmaceutical training options for your staff.  We have over 150 Subject Matter Experts (SMEs) who can deliver curriculum customized to your specific needs, covering topics ranging from pre-clinical and product discovery concerns through commercialization and beyond.  This includes traditional classroom instruction, live online training, on-demand options for use in your Learning Management System (LMS), and blended options. 

What makes LSTI different?

LSTI endeavors to provide “Actionable, Practical Instruction for Life Science Professionals” and was founded on the idea that adult learners need to be taught differently. We achieve this through real-world examples, interaction, and convenient delivery.  When you work with us to provide customized life science industry training for your staff, you can expect many benefits that most other training providers fail to deliver. Learn more about our customized pharmaceutical training and how we provide actionable, practical Instruction for life science professionals.