THE EXPERT NETWORK
Life science experts from key parts of the industry craft original columns, exclusive to Life Science Connect audiences, on the most pressing issues. This seasoned group of key contributors in the pharmaceutical, biotech, and medical device industries make up The Expert Network.
Experts are editorial contributors who expand topical coverage areas, imparting their expertise and hard-earned, first-hand best practices. However, they do much more than simply create and share content. Experts engage directly with Life Science Connect readers, sharing ideas and exchanging opinions. Digital interactions are converted to offline conversations, and The Expert Network serves as a critical link between readers and the industry at large.
Editorial by The Expert Network is featured across the integrated network of Life Science Connect digital publications, shared on social media, and distributed to readers through digital newsletters. Additionally, other industry websites and newsletters often syndicate or share content by The Expert Network — expanding the influence and delivery of value to readers in the industry.
ARTICLES FROM OUR EXPERT NETWORK
10 Critical Validation Parameters For Microbiological Experiments
In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.
What To Expect From A Remote Inspection -- & How To Navigate It
Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.
The 8-Step Checklist To Write Effective Investigation Reports
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
How To Enhance “Operational Learning” In Biopharma
According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.
5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation.
Best Practices For Designing Microbiology Experiments
A sound scientific approach can be taken for running experiments and qualification of microbiological methods. This article looks at factors to consider in drawing up assessment criteria for a microbiological test, including the limit of detection, specificity, and quantification.
Data Integrity In Supply Chain Risk Management During Zero Trust
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
A LIMS Audit Framework: What To Audit & How To Prepare
Laboratory information management systems (LIMS) are inevitably the subject of regulatory focus and audit. This article considers what to audit and how to audit a LIMS, presenting a framework useful to those planning to undertake a LIMS audit and for laboratory managers who need to prepare.
Harnessing The Power Of AI In MS Diagnosis, Monitoring, And Treatment
A prime example of the future potential of artificial intelligence (AI) is in revolutionizing the way we diagnose, monitor, and treat multiple sclerosis (MS), thereby advancing our understanding of the disease course. To maximize the utility of AI in MS, drug developers and medtech manufacturers must strategically incorporate AI solutions into their approach to MS drug development and commercialization.
Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs
Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop.
Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.
Are You Approaching LIMS Validation Correctly?
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.