Content focuses on multiple types of management in the pharmaceutical industry. Examples include Project Management, Knowledge Management, Product Management, and Plant/Site Management.
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
iSpeak Blog
The Power of Connection: Building Knowledge, Community, and Impact at ISPE
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into…
PE Articles
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
PE Articles
Process Architecture and Integrated Design in the Pharmaceutical Sector
Large engineering companies specializing in the industrial production sector have increasingly been…
PE Articles
Nurturing a Culture of Collaboration and Growth
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No…
PE Articles
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
iSpeak Blog
Announcing Pharma 4.0™ and Digitalization Transformation Track at the 2025 ISPE Europe Annual Conference in London, United Kingdom
The future of the pharmaceutical industry is being shaped by rapid advancements in digital…
PE Articles
A Skill Management Framework for a Pharma 4.0™ Workforce
Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to…
iSpeak Blog
Elevating Pharmaceutical Quality: Insights from the FDA’s Office of Quality Surveillance and ISPE’s APQ Program
Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and…
iSpeak Blog
From the Sidelines to the Field: Career Growth Through Industry Engagement
Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan…
iSpeak Blog
ISPE Members: Optimize Your Membership Experience with ISPE Engage
Unlock the Power of ISPE Engage: Your Essential Networking and Technical Hub As an ISPE member, one…
iSpeak Blog
Unlock Industry Expertise with Free Access to ISPE’s Select Guidance Documents: A Key Membership Benefit
The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (1)
Investigational Products (1)
Knowledge Management (4)
Lifecycle Management (1)
Process Analytical Technology (1)
Project Management (6)
- Good Practice Guide: Technology Transfer 3rd Edition
- Good Practice Guide: Operations Management
- Good Practice Guide: Project Management for the Pharmaceutical Industry
- Good Practice Guide: Good Engineering Practice 2nd Edition
- Good Practice Guide: Management of Engineering Standards
- The Cultural Excellence Report - Six Key Dimensions
Quality Assurance (3)
Supply Chain Management (1)
Community Discussions
Community Discussions
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Mar 20, 2025
Data Integrity
Mar 14, 2025
Advanced Manufacturing
Critical Utilities
Feb 16, 2025
Workforce of the Future
Pharmaceutical Engineering Magazine Articles
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
Process Architecture and Integrated Design in the Pharmaceutical Sector
Large engineering companies specializing in the industrial production sector have increasingly been…
Nurturing a Culture of Collaboration and Growth
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No…
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
A Skill Management Framework for a Pharma 4.0™ Workforce
Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to…
A GAMP® Approach to Computerized System Life Cycle and IT Process Records
This article describes a practical and pragmatic approach to the management of computerized system…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Post-Approval Change Management for Cell and Gene Therapy Products
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and…
Addressing the shortage of skilled workers
The success of the biopharmaceutical industry and the expansion of manufacturing facilities, of both…
Emerging Leaders Editorial: Emerging Leaders Seek to Inspire, Connect, & Elevate
ISPE’s Emerging Leaders (EL) Steering Committee is taking time to get our foundation right so that…
ISPE Briefs: New Guide Promotes Cultural Excellence
Cultural excellence is the expressed and implied ways in which an organization operates. Excellence…
White Papers
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
July / August 2022
ISPE held an Expert Xchange on 18 January 2022 that included presentations and interactive exercises…
January / February 2022
Emerging Leaders has grown from an initiative for interactions among early-career professionals and…
ISPE in the News
Latest
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Newly Revamped ISPE Volunteer Program
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Data Management Requirements for Sterile Manufacturing
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Best Practices for Getting a Drug Through Process Performance Qualification
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EU Revisiting MDR, IVDR Regulations
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Canada Invests $42M in Delpharm Manufacturing Facility
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J&J Breaks Ground on $2B Drug Substance Plant in N.C.
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AstraZeneca Plans $2.5B R&D Hub in Beijing
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Merck KGaA's Vision for Smart Manufacturing
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Automation is Key to Point-of-Care Cell Therapy Production
- AI Could Enhance Biopharma Process Validation
Pharmaceutical Job Board
iSpeak Blog Posts
Professional Development Training
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
GxPs for Leadership
This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.
Advancing Pharmaceutical Quality™ (APQ) Quality Management Maturity Training Course
The ISPE Advancing Pharmaceutical Quality™ (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and provides a range of sustainable and practical quality management improvement strategies.
GMP Fundamentals: Organization and Personnel
The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuous basis and with sufficient frequency to ensure that employees…
