The Workforce of the Future initiative ensures that recent graduates entering the industry, and our current workforce, have access to cutting-edge technical knowledge.
iSpeak Blog
ISPE Emerging Leaders Member Spotlight on Rebecca Roscher
In this blog post, Rebecca Roscher – Project Manager at Bayer AG (Supply Center Grenzach) – shares…
PE Articles
Emerging Leaders Editorial: Opportunities for Emerging Leaders and Students
We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to…
PE Articles
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…
iSpeak Blog
Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an…
PE Articles
Emerging Leaders Editorial: ISPE Opportunities for Growth in 2024
It is an exciting time to be an ISPE Emerging Leader! With conferences, professional development…
iSpeak Blog
Shaping Tomorrow: Insights from ISPE’s Facilities of the Future Executive Forum Dinner
The energy in the room was palpable as attendees eagerly awaited the start of what promised to be an…
PE Articles
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact
The Asia Pacific region (APAC), like any large territory, encompasses a blend of well-established…
PE Articles
Emerging Leaders Editorial: Personalized Medicine in the US
Personalized medicine provides a treatment alternative that utilizes patients’ genetic material to…
PE Articles
Women in Pharma® Editorial: Women’s Participation in the Pharmaceutical Industry in Mexico
Over time and with effort and determination, women in key leadership positions have proven that…
iSpeak Blog
Empowering the Aseptic Workforce: Training and Continuous Learning as an Enabler for Success
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical…
PE Articles
Emerging Leaders Editorial: What Is GAMP® & Why Is It Important?
ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) outlines…
iSpeak Blog
Navigating Life Sciences Construction in California
Few industries have as deep a footprint in California, USA as life sciences. The sector is home to…
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Pharmaceutical Engineering® Magazine
PE Articles
Emerging Leaders Editorial: Opportunities for Emerging Leaders and Students
We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to…
PE Articles
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…
PE Articles
Emerging Leaders Editorial: ISPE Opportunities for Growth in 2024
It is an exciting time to be an ISPE Emerging Leader! With conferences, professional development…
PE Articles
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact
The Asia Pacific region (APAC), like any large territory, encompasses a blend of well-established…
PE Articles
Emerging Leaders Editorial: Personalized Medicine in the US
Personalized medicine provides a treatment alternative that utilizes patients’ genetic material to…
PE Articles
Women in Pharma® Editorial: Women’s Participation in the Pharmaceutical Industry in Mexico
Over time and with effort and determination, women in key leadership positions have proven that…
PE Articles
Emerging Leaders Editorial: What Is GAMP® & Why Is It Important?
ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) outlines…
PE Articles
Emerging Leaders Editorial: Career Development Powered by AI
The healthcare field is being transformed by artificial intelligence (AI) in remarkable ways…
PE Articles
Emerging Leaders Editorial: Continuity in Manufacturing and Industry Leadership
The pharmaceutical industry is highly regulated, with strict standards for the production and…
PE Articles
Addressing the shortage of skilled workers
The success of the biopharmaceutical industry and the expansion of manufacturing facilities, of both…
PE Articles
Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence
North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort…
PE Articles
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…
Videos
Guidance Documents
Active Pharmaceutical Ingredients (3)
Advanced Manufacturing (4)
Advanced Therapy Medicinal Products (1)
Artificial Intelligence (1)
Biotechnology (6)
- Guide: ATMPs - Allogeneic Cell Therapy
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Good Practice Guide: Development of Investigational Therapeutic Biological Products
- Guide: Biopharmaceutical Process Development & Manufacturing
- Guide: ATMPs - Autologous Cell Therapy
Commissioning & Qualification (6)
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Decommissioning Pharma Equipment & Facilities
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
Compounding (2)
Containment (4)
Critical Utilities (7)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Critical Utilities GMP Compliance
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Data Integrity (16)
- 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 Good Practice Guide: Manufacturing Execution Systems
- 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
Drug Shortages (3)
GAMP® (16)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd 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 Good Practice Guide: Manufacturing Execution Systems
- 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
Good Manufacturing Practice (2)
Investigational Products (8)
- Comprehensive Guide to Clinical Materials
- Good Practice Guide: Comparator Management
- Good Practice Guide: Development of Investigational Therapeutic Biological Products
- Good Practice Guide: IMP Reverse Logistics
- Good Practice Guide: Harmonizing the Definition and Use of NIMPs
- Good Practice Guide: Clinical Supply Systems
- Good Practice Guide: Interactive Response Technology
- Introductory US Clinical Trial Materials Training Guide
Knowledge Management (7)
- GAMP RDI Good Practice Guide: Data Integrity by Design
- Good Practice Guide: Knowledge Management in Pharmaceutical Industry
- APQ Guide: Cultural Excellence
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
Lifecycle Management (6)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Guide: Biopharmaceutical Process Development & Manufacturing
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
Manufacturing Operations (10)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Guide: ATMPs - Allogeneic Cell Therapy
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
- Guide: Biopharmaceutical Process Development & Manufacturing
- Guide: ATMPs - Autologous Cell Therapy
- GAMP Good Practice Guide: Manufacturing Execution Systems
- Good Practice Guide: Maintenance 2nd Edition
- Good Practice Guide: Equipment Reliability
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Microbiological & Viral Contamination Control (16)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- Good Practice Guide: Quality Lab Facilities
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Assessing Particulate Containment 2nd Edition..
- Good Practice Guide: Containment for Potent Compounds
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: HVAC & Process Equipment Air Filters
- Good Practice Guide: Asset Management
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
- Japan Affiliate: Pest Control Manual (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Oral Solid Dosage (2)
Packaging (3)
Pharma 4.0™ (2)
Process Analytical Technology (4)
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 (8)
- Guide: 503B Compounding
- Good Practice Guide: Process Validation
- APQ Guide: Cultural Excellence
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
- PQLI Guide: Part 3 - Change Management System
- The Cultural Excellence Report - Six Key Dimensions
Quality Control (2)
Quality by Design (5)
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Regulatory (10)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Baseline Guide Vol 1: Active Pharmaceutical Ingredients
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- Good Practice Guide: Critical Utilities GMP Compliance
- 2023 ISPE Drug Shortages Prevention Model
- ISPE Readiness Report Bundle
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Single Use Technologies & Disposables (1)
Sterile Products (2)
Supply Chain Management (6)
Sustainability (2)
Sustainable Facilities, HVAC, & Controlled Environments (6)
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: Cold Chain Management
- Good Practice Guide: Assessing Particulate Containment 2nd Edition..
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Good Practice Guide: HVAC & Process Equipment Air Filters
Validation (13)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- 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
- Good Practice Guide: Process Validation
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- 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
Professional Development Training
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide 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 efficient and effective manner. Course Modules…
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…
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.