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
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…
iSpeak Blog
ISPE Philippines Women in Pharma® Soiree – An Evening of Celebration and Conversation
In celebration of International Women’s Month, ISPE Philippines Affiliate hosted an evening of…
PE Articles
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…
iSpeak Blog
ISPE’s Women in Pharma Updates: A Message from the International Steering Committee Chair
Time has a remarkable ability to slip through our fingers, doesn't it? With June's arrival, we're…
PE Articles
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…
Video
Empowering Voices: Creating a More Inclusive Pharmaceutical Industry & Patient Experience
Complimentary Learning Level: Basic Session Length: 1 hour As the healthcare landscape evolves, it's…
iSpeak Blog
The Changing Landscape: Celebrating Women's Rise in Pharma in the University Setting
Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women…
PE Articles
International Women’s Day Is 8 March
The new year is here and, with that, another International Women’s Day approaches! This incredibly…
Video
2024 ISPE International Women's Day
Today, and every day, ISPE Women in Pharma community is working to create a more inclusive…
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…
iSpeak Blog
How Men in the Industry Inspire Inclusion and Position Themselves as Allies
Aaron Bober is an active member of ISPE, the ISPE Women in Pharma® Boston Chapter, and the ISPE…
iSpeak Blog
Celebrate International Women’s Day with ISPE’s Women in Pharma
With well over a century of history and change, the first International Women's Day was held in…
Community Discussions
Community Discussions
Jun 13, 2024
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Pharmaceutical Engineering Magazine Articles
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…
Women in Pharma® Editorial: A Letter from the New WIP International Chair
As a woman of science, I can confidently say that I believe in magic. I believe in the magic that…
Women in Pharma® Editorial: Women in Pharma® Expands in Asia
The inclusive nature of ISPE promotes diversity in thought, providing pharma professionals of all…
Guidance Documents
Active Pharmaceutical Ingredients (3)
Advanced Manufacturing (4)
Advanced Therapy Medicinal Products (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 (5)
- 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 (8)
- 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: Ozone Sanitization of Pharma Water Systems
- 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 (9)
- 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 (17)
- 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: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)
- 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 (8)
- 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: Cold Chain Management
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)
- 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 (14)
- 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 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
Professional Development Training
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. Course Price: $300 (non-member) / $270 (member) Buy Now Return to Online Learning
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. Buy Now Return to…
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.
GMP Refresher
Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide an overview of History, Regulations, Quality Systems, and development, with a focus on distinguishing between QA and QC in GMP. It can serve as a GMP refresher for both individuals and companies and ensures that current key trends are covered. CEUs are provided once you achieve an 80% passing grade…
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.
iSpeak Blog Posts
White Papers
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
