Content focuses on multiple types of management in the pharmaceutical industry. Examples include Project Management, Knowledge Management, Product Management, and Plant/Site Management.
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iSpeak Blog
Highlights from the 2024 ISPE Aseptic Conference
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iSpeak Blog
Health Canada on Advanced Manufacturing and Other Trends
Related 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
Dec 20, 2024
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GAMP®
Dec 18, 2024
Dec 16, 2024
Biotechnology
Containment
Dec 11, 2024
Data Integrity
Dec 04, 2024
Good Manufacturing Practice
Dec 04, 2024
GAMP®
Lifecycle Management
Pharmaceutical Engineering Magazine Articles
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…
Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation…
Webinars Related to Management
Concept and Discussion 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…
Connectivity between Shopfloor & Manufacturing Operations Management Systems with OPC UA – A Tangible Step Toward Plug & Produce
1 Introduction Within the pharmaceutical industry one sees a general drive toward utilizing data…
Implementing Knowledge Management in Bioprocesses
1 Background and Purpose 1.1 Team Composition The authors are members of the ISPE global PAT COP…
iSpeak Blog Posts Related to Management
Training Courses Related to Management
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.
