Content focuses on multiple types of management in the pharmaceutical industry. Examples include Project Management, Knowledge Management, Product Management, and Plant/Site Management.
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
Feb 10, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Feb 06, 2025
Feb 03, 2025
Jan 30, 2025
Jan 27, 2025
Jan 27, 2025
Regulatory
Regulatory
Jan 27, 2025
Information Systems
Pharmaceutical Engineering Magazine Articles
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…
![Scientists in laboratory](/themes/custom/ispe/images/lab-workers.png)
ISPE in the News
Latest
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ISPE Training: Aseptic Processing and Annex 1 Training Course, In Person
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ISPE United Kingdom Affiliate 2024 Member of the Year: Chris Leman
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Oman Signs Purchase Agreements With 6 Drugmakers
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Hong Kong Funds Advanced Pharmaceutical Manufacturing
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Initiative Aims for RNA Vaccine Manufacturing in Egypt
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Labcorp Expands Somerset County, N.J., Facility
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MRPC Upgrades Cleanroom for Surgical Implant Components
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Recipharm Completes Production Run in Modular Sterile Filling System
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Comparison of Vaporized, Aerosolized H2O2 for Sterilization
- Iowa Biomanufacturing Center Receives $1M Grant
Pharmaceutical Job Board
iSpeak Blog Posts
Professional Development Training
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…
First Principles to Improve Pharma Manufacturing Operations Training Course
This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters.
Quality Risk Management (QRM) Workshop Training Course
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.