Mission
ISPE's Women in Pharma® group is a member-exclusive initiative committed to bridging gender, cultural, organizational, and geographic boundaries to maximize the impact women have on the pharmaceutical industry, and their respective communities.
Women in Pharma® aspires to create a pharmaceutical industry that is equitable, inclusive, free of biases and stereotypes, where diversity of thought thrives.
Vision
A pharmaceutical industry that is equitable and inclusive, free of biases and stereotypes, where diversity of thought thrives.
iSpeak Blog
Embracing Authenticity and Leadership at the 2024 ISPE Annual Meeting & Expo
This year’s 2024 ISPE Annual Meeting & Expo at Gaylord Palms in Orlando, Florida, USA was an…
PE Articles
Women in Pharma® Editorial: A Year of Remarkable Achievements
As we approach the end of another impactful year, it is a pleasure to reflect on the outstanding…
Video
Mentor ISPE Virtual Open House, Power and Led By Women in Pharma
Mentor ISPE Virtual Open House, Power and Led By Women in Pharma ® Session Length: 1 hour We are…
iSpeak Blog
Mentor ISPE 2025—Key Dates and Application Details
The 2025 Mentor ISPE program promises to be a transformative year filled with growth, collaboration…
iSpeak Blog
Women in Pharma® Member Spotlight on Mei Ping Lee, Chair of the ISPE Malaysia Affiliate’s Women in Pharma®
With over 23 years industrial hands-on experience in establishing and managing quality management…
iSpeak Blog
A Message from ISPE’s Women in Pharma® International Steering Committee Chair: Women in Pharma® Plans at the 2024 ISPE Annual Meeting & Expo
The 2024 ISPE Annual Meeting & Expo, taking place 13 – 16 October in Orlando, Florida, USA, and…
Video
Women in GAMP®
Women in GAMP ® Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Join us for…
iSpeak Blog
AstraZeneca Invites You to Attend ISPE’s Women in Pharma® Masked Connections: A Networking Soiree
Building on last year’s successful collaboration, AstraZeneca is once again stepping up to support…
iSpeak Blog
AI-Driven Efficiency in Modern Workspaces: An ISPE Women in Pharma® Panel Discussion Recap
At the 2024 ISPE Biotechnology Conference, which took place on 17 - 18 June in Boston, Massachusetts…
iSpeak Blog
Join the Global Movement: Mentor ISPE’s Year Three
ISPE Women in Pharma ®’s dedication to diversity, equity, and Inclusion isn't just about aspirations…
iSpeak Blog
Women in Pharma® Member Spotlight on Miriam Kremer-van der Kamp
Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE…
PE Articles
Women in Pharma® Editorial: Empowering Women in Regulatory Affairs
In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement…
Community Discussions
Community Discussions
Nov 03, 2024
Women in Pharma®
Jun 13, 2024
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Webinars
Pharmaceutical Engineering Magazine Articles
Women in Pharma® Editorial: A Year of Remarkable Achievements
As we approach the end of another impactful year, it is a pleasure to reflect on the outstanding…
Women in Pharma® Editorial: Empowering Women in Regulatory Affairs
In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement…
Women in Pharma® Editorial: Women in Pharma® at the 2024 ISPE Annual Meeting & Expo
Long gone are the days of early morning Women in Pharma breakfast meetings at ISPE international…
Women in Pharma® Editorial: An Era of Innovation and Emerging Technologies
The emergence of new modalities and innovations on drug development and research, such as advanced…
International Women’s Day Is 8 March
The new year is here and, with that, another International Women’s Day approaches! This incredibly…
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…
Women in Pharma® Editorial: The Future of Women in Pharma®
An ISPE campaign in 2016 piqued my interest in the Women in Pharma committee because I’m an advocate…
A Letter from ISPE’s Women in Pharma® Chair
We welcomed 2023 with high hopes and dreams of what Women in Pharma ® could eventually be. As I…
Women in Pharma® Editorial: Transcending Boundaries and Making Connections Matter
For the past few months, ISPE Asia Pacific Affiliates and Chapters have been busy reconnecting with…
Women in Pharma® Editorial: Can Communication in a Multigenerational Environment Be Inclusive?
The multigenerational environment we work in poses unique challenges that make effective…
Women in Pharma® Editorial: Industry Growth Generates Opportunity & Diverse Workforce
As a woman in the pharma industry, I have witnessed firsthand the growth of the industry in the…
Women in Pharma® Editorial: Mentor ISPE Launches for All Genders
Arriving in the United States at the age of 17 to pursue my dreams was one of the greatest…
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.
iSpeak Blog Posts
White Papers
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
