PE Magazine | September / October 2024
Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape.

Read More
PE Magazine | September / October 2024
Finding the Assurance in Computer Software Assurance

Computer software assurance (CSA) has been discussed widely in industry over the past five years. While the principles are well understood and welcomed, until now some of the practical detail on how exactly to implement CSA into an organization has been missing.

Read More
iSpeak Blog | 25 September 2024
Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference

In the ever-evolving landscape of the pharmaceutical industry, staying ahead of the curve is not just an advantage—it's a necessity.

Read More
2024 ISPE Annual Meeting & Expo View Agenda Guidance Documents 75+ documents available Membersip Join 22,000+ members

ISPE Highlights

GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
A Message from ISPE’s Women in Pharma® International Steering Committee Chair: Women in Pharma® Plans at the 2024 ISPE Annual Meeting & Expo
Keynote speaker
Setup and Implementation of Digital Validation Tools
Pharma 4.0™ Interconnected Facility Design and Construction
Data Integrity and Large-Scale Systems
2024 ISPE FOYA Category Winner for Operations – Facility Fit; Takeda Austria GmbH
Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
Demographic breakdown and engagement of survey respondents in the pharmaceutical sector

Pharmaceutical Engineering Magazine

View All

Guidance Documents

Regulatory Initiatives

Quality Culture
QC Regulatory
Product Quality Lifecycle Implementation (PQLI) ®
Lifcyc Mgmt Regulatory
Advancing Pharmaceutical Quality™
QA Regulatory
View All

Highlights From ISPE Knowledge Network

Explore webinars, training PE articles, and more relevant to your job function.
 
Facilities & Equipment
  1. 2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited
  2. 2024 ISPE FOYA Category Winner for Operations – Facility Fit: Takeda
  3. 2024 ISPE FOYA Category Winner – Honorable Mention: United Therapeutics Corporation
  4. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
View Related Content
Information Systems
  1. ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data
  2. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  3. Setup and Implementation of Digital Validation Tools
  4. Data Integrity and Large-Scale Systems
View Related Content
Management
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
View Related Content
Product Development
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
View Related Content
Quality
  1. ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data
  2. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  3. Pharma 4.0™ Interconnected Facility Design and Construction
  4. Data Integrity and Large-Scale Systems
View Related Content
Regulatory
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. A Holistic Mindset is Key to Supply Resiliency
View Related Content
Supply Chain
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
View Related Content

Conferences

2024 ISPE Pharma 4.0™ and Annex 1 Conference

-
Rome, Italy IT

2025 ISPE Facilities of the Future Conference

-
San Francisco, CA US

2025 ISPE Aseptic Conference

-
ARLINGTON, VA US

2025 ISPE Europe Annual Conference

-
London, GB

2025 ISPE Biotechnology Conference

-
Boston, MA US
View All

Webinars

Upcoming
On-Demand
 
ISPE FOYA Submission Best Practices
ISPE FOYA Submission Best Practices Complimentary Learning Level: Basic Time: 1100 - 1200 EDT…
AI/ML in Regulated Life Sciences (GxP) Sectors - Project/Operation Phase: Computerized System Integration and Acceptance
AI/ML in Regulated Life Sciences (GxP) Sectors - Project/Operation Phase: Computerized System…
Mentor ISPE Virtual Open House, Power and Led By Women in Pharma
Mentor ISPE Virtual Open House, Power and Led By Women in Pharma® Time: 1000 - 1100 EST Session…
Medical Device Sterilization with FDA
Medical Device Sterilization with FDA Complimentary Learning Level: Intermediate/Advanced Time: 1100…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Time: 1600…
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
Quality Culture Matters: Key to Unlocking the Digital Validation Power
Quality Culture Matters: Key to Unlocking the Digital Validation Power Extended Learning Learning…
View All
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations Lifecycle
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations…
ALCOA++: Leveling Up Data Integrity
ALCOA++: Leveling Up Data Integrity Complimentary Session Length: 1 hour ALCOA has been the hallmark…
Women in GAMP®
Women in GAMP ® Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Join us for…
The Use of Engineering Change Management (ECM)
Complimentary Learning Level: Basic Session Length: 1 hour Asset Life Cycle Management evolves in…
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers Complimentary Learning Level…
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
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…
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation Complimentary Learning…
Digital Display Labeling in Clinical Trial Supply Chains
Digital Display Labeling in Clinical Trial Supply Chains Complimentary Learning Level: Basic Session…
Connecting ATMP Discovery to Commercial: Improving Manufacturability
Connecting ATMP Discovery to Commercial: Improving Manufacturability Complimentary Learning Level…
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations Complimentary…
View All

Training Courses

Upcoming
On-Demand
 
2024 ISPE Pharma 4.0™ and Annex 1 Conference - Training
-
Rome, IT
Bethesda | Oct 2024
-
North Bethesda, MD US
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
-
Strasbourg, FR
2025 ISPE March Training
-
Online Live, US
2024 ISPE Annual Meeting & Expo - Training
-
Orlando, FL US
2024 ISPE December Online Live Training
-
Online Live, US
2024 ISPE November Online Live Training
-
Online Live, US
2024 ISPE October Online Live Training
Online Live, US
2025 ISPE February Online Live Training
-
Online Live, US
2024 ISPE November In Person Training
-
North Bethesda, MD US
View All
View All
Access Your Member Benefits
Collaborate on a global scale, drive innovation, lead conversations, and more. Become a member of ISPE.
Arrow 42 YEARS of serving pharma professionals Arrow 20,000+ MEMBERS in over 120 countries Arrow 40 AFFILIATES AND CHAPTERS worldwide Arrow 70+ GUIDANCE DOCUMENTS written by ISPE Members Arrow 6+ INTERNATIONAL CONFERENCES per year Arrow A ROBUST LIBRARY of learning resources Arrow 24-HOUR ACCESS to ISPE Members worldwide
Learn More Join Now

Increased Access to Good Practice Guides

With an ISPE membership, you’ll gain access to 24+ Good Practice Guides.

Good Practice Guide
Guide Cover
C&Q of Pharma Water & Steam Systems 2nd Edition
Good Practice Guide
Guide Cover
Assessing Particulate Containment 2nd Edition
Good Practice Guide
Guide Cover
Asset Management
Good Practice Guide
Guide Cover
Booklet Labels
Good Practice Guide
Guide Cover
Clinical Supply Systems
Good Practice Guide
Guide Cover
Cold Chain Management
Good Practice Guide
Guide Cover
Comparator Management
Good Practice Guide
Guide Cover
Decommissioning Pharma Equipment & Facilities
Good Practice Guide
Guide Cover
Development of Investigational Therapeutic Biological Products
Good Practice Guide
Guide Cover
Harmonizing the Definition and Use of NIMPs
Good Practice Guide
Guide Cover
Heating, Ventilation, & Air Conditioning (HVAC)
Good Practice Guide
Guide Cover
HVAC & Process Equipment Air Filters
Good Practice Guide
Guide Cover
Interactive Response Technology
Good Practice Guide
Guide Cover
Management of Engineering Standards
Good Practice Guide
Guide Cover
Operations Management
Good Practice Guide
Guide Cover
Ozone Sanitization of Pharma Water Systems
Good Practice Guide
Guide Cover
Packaging, Labeling, & Warehousing Facilities
Good Practice Guide
Guide Cover
Process Validation
Good Practice Guide
Guide Cover
Process Gases
Good Practice Guide
Guide Cover
Project Management for the Pharmaceutical Industry
Good Practice Guide
Guide Cover
Quality Lab Facilities
Good Practice Guide
Guide Cover
Sampling Pharma Water, Steam, & Process Gases
Good Practice Guide
Guide Cover
Single-Use Technology
Good Practice Guide
Guide Cover
Technology Transfer

Get Involved

Enhance your ISPE Membership through involvement at the local and international level. Through knowledge sharing, networking, and engaging thought leadership, you can contribute to shaping the future of the pharmaceutical industry.
Join Your Local Affiliate or Chapter Arrow Join a Community of Practice Arrow Become a Thought Leader Arrow

ISPE Membership

ISPE is the most dynamic community in the industry, with a global network of 20,000+ professionals spanning the complete pharmaceutical lifecycle. With resources available for all stages of your career, an ISPE Membership is a career game changer.
Join or Renew Today Arrow Member Benefits Arrow Learn About Membership Arrow

Community Discussions

Oct 08, 2024
Validation
Oct 01, 2024
Information Systems
Validation
Sep 30, 2024
GAMP®
Pharma 4.0™
Sep 19, 2024
Sep 18, 2024
Knowledge Management
Process Analytical Technology

Videos

Recommended
Latest
 
2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited
2024 ISPE FOYA Category Winner for Operations – Facility Fit: Takeda
2024 ISPE FOYA Category Winner – Honorable Mention: United Therapeutics Corporation
View All
Attend the 2024 ISPE Biotechnology Conference
2024 ISPE International Women's Day
2024 ISPE Aseptic Conference - Why Attend
View All

Industry News

Latest
Visit Newsroom

Latest Issue

September / October 2024

September / October 2024

PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry...
View This Issue

Corporate Partners

View Corporate Partners