Content focuses on multiple types of management in the pharmaceutical industry. Examples include Project Management, Knowledge Management, Product Management, and Plant/Site Management.
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
iSpeak Blog
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry…
iSpeak Blog
Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
The 2025 Facilities of the Future Conference will explore innovations in facility design and…
iSpeak Blog
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
iSpeak Blog
Peer Companies Share Knowledge on Project/Asset Management Interfaced and Shutdown Management in Recent Asset Management Benchmarking Session
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified…
Video
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
iSpeak Blog
Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
As with all aspects of our life sciences industry, understanding how we can best meet the needs of…
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
Nov 20, 2024
Regulatory
Regulatory
Nov 18, 2024
Regulatory
Regulatory
Nov 17, 2024
Sustainable Facilities, HVAC, & Controlled Environments
Manufacturing Operations
Nov 17, 2024
Nov 04, 2024
Information Systems
Management
Pharma 4.0™
Project Management
Nov 04, 2024
Regulatory
Supply Chain
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Nov 03, 2024
Women in Pharma®
Pharmaceutical Engineering Magazine Articles
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…
ISPE Briefs: New APQ Guide Develop a Robust and Efficient Change Management System
Effective and timely management of change throughout the product life cycle enables quality…
Webinar: Knowledge Management Insights and More
On 26 January 2022, representatives of the author team for the ISPE Good Practice Guide: Knowledge…
Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and…
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
-
While armchair travelers dream of going places, traveling armchairs dream of staying put.
-
Roger Nosal Recognized with the Richard B. Purdy Distinguished Achievement Award
-
ISPE Training, GAMP® Data Integrity 21 CFR Part 11, 3-5 December, Online Live
-
Baxter Resumes IV Fluid Production at N.C. Plant
-
Frontier Scientific to Create Fast Lane Between US, Ireland for Life Sciences Supplies
-
Avantor opens Innovation Center in N.J.
-
BioCina to Scale Novel Resin-producing Cells
-
Terumo Aortic's new Glasgow Facility Designed for Sustainability
-
Sanofi Investment Boosts mAb Production in France
- Collaboration with CDMOs Aids Oligo, Peptide Development
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.
