Feature: Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to workforce development. This article proposes a skill management framework aimed at empowering companies to develop a future-ready workforce, including practical insights within the context of Pharma 4.0™.
Feature: For companies producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in be er research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide.
Feature: Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No organization survives for a long period of time if it does not change with the times. The pace of change is accelerating, and the scale of disruptive market forces is growing by the day.
Technical: Drug stability data that deviate from an expected trend when compared to other stability batches or historical data collected during stability studies are considered out-of-trend (OOT) results. According to the US Food and Drug Administration’s “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry,” OOT results should be limited and scientifically justified.
Technical: The production of advanced therapy medicinal products (ATMPs) can have many complex manual steps, which necessitates meticulous aseptic processing conditions to ensure the product is sterile, which is critical for patient safety. Closed isolator systems provide a consistent, compliant, and cost-effective solution, and can play a critical role in ensuring the safety of ATMPs.
Being a working mom has shaped my career in unexpected ways. Early in my career, a colleague who had just become a mother told me that you can’t “have it all”—a thriving career, a happy home life, and a fulfilling personal life.
The expectations for the workforce joining the industry right now are slightly daunting. It can feel like being required to be everything at once: flexible but driven by purpose, extremely adaptable but stable at the core, empathetic but independent, and knowledgeable but versatile.
Crafting and communicating a vision for the organization is one of the most important and visible jobs of a leader. It is also a difficult job, and executing plans to realize the vision is even more difficult.
Our March/April issue focuses on the workforce of the future. This is a critical theme for us: ISPE’s vision includes a focus on member and workforce development, as well as technical, regulatory, and quality leadership, as we continue to shape the future of the global pharmaceutical industry. This is particularly important with the industry’s growing skills gap.
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Isabella Stoup, the ISPE Foundation, Senior Coordinator, Development.
Ferdinando E. Aspesi, PhD, is a Senior Partner at Bridge Associates International, LLC, New Jersey, USA, where he advises pharmaceutical companies on quality strategy, organizational design, and quality and compliance issues. In his more than 44 years of experience in the industry, Aspesi has worked in active pharmaceutical ingredient (API) and drug products quality assurance and quality...
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both manufacturing and service organizations. She is the Founder and Managing Director of MIME Solutions Ltd., a consultancy that has been providing support to the global pharmaceutical industry for 21 years in areas such as project, quality, and risk management, as well as in developing...
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No organization survives for a long period of time if it does not change with the times. The pace of change is accelerating, and the scale of disruptive market forces is growing by the day.
For companies focused on producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in better research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide.
