Content focuses on feature key components and the financial impact of supply and distribution chains. Topics focus on the systems required to control and automate the receipt, storage, and dispensation of raw and packaging materials and the storage and distribution of finished products. Other topics could include materials management, operational economics, and warehouse and distribution management.
Video
Blue Sky Lab Automation for the QC Industry
Blue Sky Lab Automation for the QC Industry Complimentary Learning Level: Advanced Session Length: 1…
Video
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
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Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
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
Unlock the Future of Pharmaceutical Manufacturing: Learn from Industry Leaders at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference
In an era where technological advancements are reshaping every industry, the pharmaceutical sector…
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…
iSpeak Blog
Roger Nosal Recognized with the Richard B. Purdy Distinguished Achievement Award for His Impact on ISPE and the Global Pharmaceutical Industry
The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in…
iSpeak Blog
Embracing Authenticity and Leadership at the 2024 ISPE Annual Meeting & Expo
This year’s 2024 ISPE Annual Meeting & Expo at Gaylord Palms in Orlando, Florida, USA was an…
iSpeak Blog
Beyond Automation: The Human Touch in Industry 5.0
The future of manufacturing is not a battle between humans and machines. It is a collaboration that…
iSpeak Blog
Updated ISPE HVAC Guide Provides Support for Professionals at All Levels of Experience
In September, ISPE released the second edition of their Good Practice Guide on Heating, Ventilation…
iSpeak Blog
Member Spotlight: Daria Curtis
Daria Curtis works in quality assurance validation at AstraZeneca and is a member of ISPE. In this…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (1)
Investigational Products (1)
Packaging (1)
Project Management (1)
Regulatory (1)
Single Use Technologies & Disposables (1)
Supply Chain Management (6)
Sustainable Facilities, HVAC, & Controlled Environments (1)
Community Discussions
Community Discussions
Nov 25, 2024
Biotechnology
Nov 25, 2024
Data Integrity
Nov 25, 2024
GAMP®
Nov 25, 2024
Data Integrity
Nov 21, 2024
Regulatory
Regulatory
Nov 18, 2024
Regulatory
Regulatory
Nov 17, 2024
Sustainable Facilities, HVAC, & Controlled Environments
Manufacturing Operations
iSpeak Blog Posts
Webinars
ISPE in the News
Latest
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I never thought I was ever going to be a travel writer. I was just having a wonderful time traveling on the slimmest of funds.
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Mentor ISPE 2025
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A Message from the 2025 ISPE Aseptic Conference Chair
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Pii Invests $3.6M in Advanced Tech for Prefilled Syringes
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Sartorius Opens Bioprocess Innovation Hub in Mass.
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Fujifilm Diosynth Expands Calif. Cell Therapy Plant
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Netherlands Grants GMP Certification to Ardena Nanomedicine Plant
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BioPharmaSpec Expands with 3 European Facilities
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Execution Inconsistencies Hamper Validation Efficiency
- Potential US FDA Policy Shifts on the Horizon
Pharmaceutical Engineering Magazine Articles
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…
Global Convergence Opportunities
The regulation of drug shortage prevention has rapidly changed over the past several years due to…
Digital Display Labeling in Clinical Supplies for Clinical Trials
Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the…
ATMP-Focused Online Seminars Educate and Inspire
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements…
Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains
Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the…
Considerations for a Decentralized Manufacturing Paradigm
The biopharmaceutical industry must develop and implement innovative ways of working to be effective…
ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply
ISPE task teams created reports and a model to examine the challenges surrounding drug shortages…
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…
Supplier Qualification Program for Key Raw Materials
With the publication of recent guidance, specifically the US FDA Quality Systems Approach to…
Drug Shortages: a 30,000 Ft View: Business Continuity Planning for Preventing Drug Shortages
As noted in the ISPE Drug Shortages Prevention Plan, International Society for Pharmaceutical…
Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing…
White Papers
March / April 2023
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
Videos
Professional Development Training
GMP Fundamentals: Holding & Distribution
In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours. Buy Now Return to Online Learning
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