Content focuses on multiple types of management in the pharmaceutical industry. Examples include Project Management, Knowledge Management, Product Management, and Plant/Site Management.
Video
2025 ISPE Annual Meeting & Expo - What to Expect
Discover why the 2025 ISPE Annual Meeting & Expo is a can't-miss event. Find opportunities to…
PE Articles
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…
iSpeak Blog
Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
At the 2024 ISPE Annual Meeting & Expo, held 13-16 October in Orlando, Florida, USA Nina Cauchon…
iSpeak Blog
FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US Food and Drug…
iSpeak Blog
A Message from the 2025 ISPE Aseptic Conference Chair
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has…
iSpeak Blog
Overcoming Fear of the Engineer-Procure-Construct (EPC) Model to Recognize Project Execution Benefits
In an increasingly complex world, where the reliable delivery of power from point A to point B often…
PE Articles
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
PE Articles
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
iSpeak Blog
Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
The proliferation of digital tools available in the pharmaceutical industry, including artificial…
Video
Women in GAMP®
Women in GAMP ® Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Join us for…
iSpeak Blog
Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
In the ever-evolving landscape of the pharmaceutical industry, staying ahead of the curve is not…
Video
The Use of Engineering Change Management (ECM)
Complimentary Learning Level: Basic Session Length: 1 hour Asset Life Cycle Management evolves in…
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
Jan 28, 2025
Jan 27, 2025
Jan 27, 2025
Regulatory
Regulatory
Jan 27, 2025
Information Systems
Jan 27, 2025
Regulatory
Regulatory
Jan 27, 2025
Good Manufacturing Practice
Sustainable Facilities, HVAC, & Controlled Environments
Jan 26, 2025
Data Integrity
Pharmaceutical Engineering Magazine Articles
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…
ISPE 2022 Member of the Year: Martin Lipa - An Advocate for Knowledge Management
When nominating Martin (Marty) Lipa, Executive Director, Knowledge Management, Merck & Co. Inc., for…
Case Study: Meeting Manufacturing Needs with a Net Zero Energy Facility
The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer…
Sustainability: Corporate Ambition, Governance, & Accelerated Delivery
The imperative for global action to tackle climate change is clear and the pharmaceutical industry…
Sustainability Definitions for the Pharmaceutical Industry
While financial investment in novel therapies provides patients with new treatment options and…
Sustainability by Design for Pharmaceutical Products
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
Webinars
White Papers
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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Choice is the essence of what I believe it is to be human.
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ISPE Webinar: Improved Data Integrity via Digitization of Environmental Monitoring (EM)
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Regulation and Pharma 4.0™ at the 2025 ISPE Aseptic Conference
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CDER Aims to Issue 28 New Guidance Documents This Year
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Brenner Appointed Acting US FDA Commissioner
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Modular, Automated Bioreactor Cultures Human iPSCs
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Hybrid Bioreactor Produces Proteins from CO2
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MBV Introduces Automated Cleanroom Monitoring System
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BeiGene Opens $800M Biopharma Center in N.J.
- What To Do After Finding Defective Vials
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…
