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
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…
iSpeak Blog
ISPE Member Spotlight: Lindsey Daniel
Lindsey Daniel, Director of Product Operations Strategy and Business Lead at Takeda, is an exemplary…
Video
Holistic Pharma 4.0 Digital Maturity Assessment
Holistic Pharma 4.0 Digital Maturity Assessment Complimentary Learning Level: Basic Session Length…
iSpeak Blog
The Importance of GAMP® in the Pharmaceutical Industry
In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount…
iSpeak Blog
Pharmaceutical Compounding: A US FDA Perspective
The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of…
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…
PE Articles
Ensure Safe Chemical Transport with GF’s Double Containment Systems
Engineered for critical applications, GF Piping Systems’ advanced double containment solutions…
iSpeak Blog
Approaches to Lifecycle Management and Regulatory Readiness in Advanced Therapies
At the 2024 ISPE Annual Meeting & Expo, a session focused on lifecycle management considerations for…
Video
CSV vs CSA: GAMP 5's Actionable Steps to Transitioning Your Validation
CSV vs CSA: GAMP 5's Actionable Steps to Transitioning Your Validation Complimentary Learning Level…
iSpeak Blog
Data Management Requirements for Sterile Manufacturing
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety…
Basic page
ISPE Volunteer Program FAQs
What is the ISPE Volunteer Program? The ISPE Volunteer Program offers members opportunities to…
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…
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
Feb 16, 2025
Workforce of the Future
Feb 15, 2025
Manufacturing Operations
Feb 13, 2025
Manufacturing Operations
Oral Solid Dosage
Feb 10, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Feb 06, 2025
Feb 03, 2025
Jan 30, 2025
iSpeak Blog Posts
Webinars
ISPE in the News
Latest
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Aseptic Processing and Annex 1 Training Course, In Person, 19-20 March, Washington, D.C., USA
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ISPE Member Spotlight: Lindsey Daniel
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WuXi Biologics Launches System to Make Complex Molecules
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Navigating US, EU Requirements for Combination Products
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European Biopharma Firms Explore Nearshore Production
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US FDA Lab in St. Louis Spared From Closure
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Repligen Buys Bioprocessing Analytics From 908 Devices
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Centralized vs. Decentralized Cell Therapy Manufacturing
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AI Lifecycle Management Crucial in Drug Development
- US Pharmacopeia Highlights Shortage Risks for 100 Drugs
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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