PE Magazine | September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures

This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry.

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PE Magazine | September / October 2024
Industry Perspectives on Practical Application of Platform Analytical Procedures

Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14.

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iSpeak Blog | 16 September 2024
Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo

The 2024 ISPE Annual Meeting & Expo, taking place 13 – 16 October in Orlando, Florida, USA and virtually is set to be a landmark gathering for pharmaceutical engineering professionals.

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

ISPE Highlights

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
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Women in Pharma® Events
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Facilities & Equipment
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Pharma 4.0™ Interconnected Facility Design and Construction
  3. 2024 ISPE FOYA Category Winner for Operations – Facility Fit; Takeda Austria GmbH
  4. Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
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Information Systems
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Setup and Implementation of Digital Validation Tools
  3. Data Integrity and Large-Scale Systems
  4. The 7th ISPE Pharma 4.0™ Survey: Digital Transformation
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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
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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. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Pharma 4.0™ Interconnected Facility Design and Construction
  3. Data Integrity and Large-Scale Systems
  4. Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
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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
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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
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Conferences

2024 ISPE Annual Meeting & Expo

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Kissimmee, FL US

2024 ISPE Pharma 4.0™ and Annex 1 Conference

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Rome, Italy IT

2025 ISPE Facilities of the Future Conference

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San Francisco, CA US

2025 ISPE Aseptic Conference

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ARLINGTON, VA US

2025 ISPE Europe Annual Conference

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London, GB

2025 ISPE Biotechnology Conference

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Boston, MA US
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Webinars

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Unique Glass Primary Containers Identification in Pharmaceutical Fill & Finish Operations
Unique Glass Primary Containers Identification in Pharmaceutical Fill & Finish Operations…
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…
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…
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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…
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
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Training Courses

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2024 ISPE Pharma 4.0™ and Annex 1 Conference - Training
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Rome, IT
Bethesda | Oct 2024
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North Bethesda, MD US
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
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Strasbourg, FR
2025 ISPE March Training
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Online Live, US
2024 ISPE Annual Meeting & Expo - Training
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Orlando, FL US
2024 ISPE December Online Live Training
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Online Live, US
2024 ISPE November Online Live Training
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Online Live, US
2024 ISPE October Online Live Training
Online Live, US
2025 ISPE February Online Live Training
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Online Live, US
2024 ISPE November In Person Training
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North Bethesda, MD US
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C&Q of Pharma Water & Steam Systems 2nd Edition
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Assessing Particulate Containment 2nd Edition
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Asset Management
Good Practice Guide
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Booklet Labels
Good Practice Guide
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Clinical Supply Systems
Good Practice Guide
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Cold Chain Management
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Comparator Management
Good Practice Guide
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Decommissioning Pharma Equipment & Facilities
Good Practice Guide
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Development of Investigational Therapeutic Biological Products
Good Practice Guide
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Harmonizing the Definition and Use of NIMPs
Good Practice Guide
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Heating, Ventilation, & Air Conditioning (HVAC)
Good Practice Guide
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HVAC & Process Equipment Air Filters
Good Practice Guide
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Interactive Response Technology
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Management of Engineering Standards
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Operations Management
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Ozone Sanitization of Pharma Water Systems
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Packaging, Labeling, & Warehousing Facilities
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Process Validation
Good Practice Guide
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Process Gases
Good Practice Guide
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Project Management for the Pharmaceutical Industry
Good Practice Guide
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Quality Lab Facilities
Good Practice Guide
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Sampling Pharma Water, Steam, & Process Gases
Good Practice Guide
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Single-Use Technology
Good Practice Guide
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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...
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