Content focuses on the financial impact of data management systems on drug development, manufacturing, and distribution; the basic computer system life cycle model and the activities and software quality assurance practices in each phase; and the controls and methods necessary to maintain data integrity and security.
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
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…
PE Articles
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
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…
PE Articles
2024 State of Validation Report
Unlock the latest insights and trends in validation practices with the 2024 State of Validation…
PE Articles
The CDMO Handbook: Overcoming Industry Challenges With Digital Validation
Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing…
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…
Guidance Documents
Advanced Manufacturing (1)
Commissioning & Qualification (1)
Data Integrity (15)
- Baseline Guide Vol 8: Pharma 4.0 1st Edition
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
GAMP® (14)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Knowledge Management (1)
Pharma 4.0™ (1)
Validation (11)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
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
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
Artificial Intelligence Governance in GxP Environments
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from…
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
2024 ISPE Facilities of the Future Conference: Keynote Presentations
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California…
2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
Pharma 4.0™ Plug and Produce Working Group Publishes Concept Papers
One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to…
ISPE Briefs: Introducing New ISPE Baseline® Guides
The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical…
Leveraging GAMP® 5 Second Edition for Medical Devices
This article provides a brief introduction into the standards and regulations for medical devices…
The Use of Infrastructure as Code in Regulated Companies
IT infrastructure has traditionally been provisioned using a combination of scripts and manual…
Quality Considerations in Disaster Recovery: A Case Study
Due to the growing digitalization of the industry, we are highly dependent on information technology…
Machine Learning Risk and Control Framework
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
Hands-on Innovation Management with the ISPE Hackathon
Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are…
White Papers
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
March / April 2022
This article aims to refresh information on open-source software (OSS) within regulated computerized…
Webinars
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
Special Initiatives
Videos
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Video
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation Complimentary Learning…
Video
Digital Display Labeling in Clinical Trial Supply Chains
Digital Display Labeling in Clinical Trial Supply Chains Complimentary Learning Level: Basic Session…
Video
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
Video
Register Now for the 2024 ISPE Annual Meeting & Expo
This signature gathering is not just an opportunity to learn but also to connect. From emerging…
Video
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets…
Video
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment…
Video
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design Next-Generation Virtual…
Professional Development Training
GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This…
GMP Fundamentals: Quality System
To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work together, and establishes performance specifications. The Quality System provides mechanisms to monitor and control processes, systems, and people to ensure the highest level of safety, quality, and efficacy. In this On Demand course (part 3 of 11), you will learn the elements of a Quality System, as…
Cloud Concepts - Cyber Security and Block Chain
This online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of regulatory compliance will be explored and answers on how one can comply will be provided. If already operating in the cloud, attendees will be gain insight on how they can assess their own company's cloud platform, and take proactive measures to resolve any vulnerabilities.
Asset Information Lifecycle Modelling
The information that forms the records of an operating facility are increasingly being recognized as a vital part of a facility. This ' digital asset' reflects the value of data that mirrors the physical assets. The genesis of this digital asset (engineering data) is created and collected from various disparate sources. This information is also consumed by a variety of disparate functions. To facilitate the efficient creation, manipulation and consumption of engineering information it is important to define a master data model for the whole asset lifecycle. The identification of the…
Basic Principles of Computerized Systems Compliance
Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-Based Approach to Compliant GxP Computerized Systems This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an…
View Course
Quality Management Systems Training Course
Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.
GAMP® Basic Principles 2-Day Training Course
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.