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.
iSpeak Blog
Hacker to GAMPer: Year One
In this blog post, ISPE Emerging Leader member Peyton Myers, details his experience in his first…
iSpeak Blog
Regulation and Pharma 4.0™ at the 2025 ISPE Aseptic Conference
Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each…
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…
iSpeak Blog
“Technology, Digital Transformation, and Pharma 4.0™” track for 2025 ISPE Facilities of the Future Conference
In the “Technology, Digital Transformation, and Pharma 4.0™” track at the upcoming 2025 ISPE…
Video
Quality Culture Matters: Key to Unlocking the Digital Validation Power
Quality Culture Matters: Key to Unlocking the Digital Validation Power Extended Learning Learning…
iSpeak Blog
Takeda Recognized with the ISPE Company of the Year Award for Outstanding Leadership and Support
The 2024 ISPE International Honor Awards enable the ISPE community to recognize and celebrate the…
iSpeak Blog
Facilities Design and Delivery at the 2025 ISPE Facilities of the Future Conference
As the pharmaceutical industry continues to evolve at an unprecedented rate, the design and delivery…
Basic page
ISPE Regulatory Digest Q4 2024
ISPE is committed to fostering communications and interactions to advance common interests among the…
iSpeak Blog
Strategic Planning for Measurable Outcomes in Pharmaceutical Manufacturing
In the fast-paced and ever-evolving world of pharmaceutical manufacturing, companies must respond to…
iSpeak Blog
ISPE Chesapeake Bay Area Chapter Recognized with the ISPE Affiliate and Chapter Excellence Award
The 2024 ISPE International Honor Awards, presented at the 2024 ISPE Annual Meeting & Expo, enable…
PE Articles
The Role of AI and ML in Efficiency and Innovation
The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess…
PE Articles
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
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
Jan 28, 2025
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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
iSpeak Blog Posts
Webinars
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 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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