iSpeak Blog | 14 September 2023
ISPE GAMP SIG MES Planning to Move the Industry Forward

With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents.

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iSpeak Blog | 14 September 2023
Artificial Intelligence (AI) Based Continued Process Verification (CPV)
Continued Process Verification (CPV) was introduced roughly 12 years ago by the FDA as a third stage in the guidance on the process validation life cycle. In addition to being a mandatory requirement for the pharmaceutical industry, CPV can also provide valuable information to improve the quality and consistency of products.
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iSpeak Blog | 16 October 2023
Fireside Chat with Robert Califf, MD & Tom Hartman
A fireside chat featuring Robert M. Califf, MD, FDA’s 25th Commissioner of Food and Drugs, and Thomas B. Hartman, President and CEO of ISPE kicked off the 2023 ISPE Annual Meeting & Expo. The following is a brief summary of the session. Look for complete coverage of the interview in an upcoming issue of Pharmaceutical Engineering® magazine.
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ISPE Highlights

Regulatory Panel - ISPE 2023 Annual Meeting & Expo
Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science.
Health Canada on Advanced Manufacturing and Other Trends
Eco-friendly Pharma: Sterilization and Sustainable Practices
Production 4.0 - A Digital Path to Significant Business Improvements
Guidance Documents
Students and Recent Graduates
2023 ISPE Aseptic Conference
Flexibility in Facility Design and Delivery - Genentech hall Interior
New Board Chair: Scott Billman

Pharmaceutical Engineering Magazine

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Guidance Documents

Regulatory Initiatives

Quality Culture
QC Regulatory
Product Quality Lifecycle Implementation (PQLI) ®
Lifcyc Mgmt Regulatory
Advancing Pharmaceutical Quality
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Highlights From ISPE Knowledge Network

Explore webinars, training PE articles, and more relevant to your job function.
 
Facilities & Equipment
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  3. Health Canada on Advanced Manufacturing and Other Trends
  4. Eco-friendly Pharma: Sterilization and Sustainable Practices
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Information Systems
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  3. Health Canada on Advanced Manufacturing and Other Trends
  4. Eco-friendly Pharma: Sterilization and Sustainable Practices
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Management
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  3. Health Canada on Advanced Manufacturing and Other Trends
  4. Eco-friendly Pharma: Sterilization and Sustainable Practices
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Product Development
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  3. Health Canada on Advanced Manufacturing and Other Trends
  4. Eco-friendly Pharma: Sterilization and Sustainable Practices
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Quality
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. ISPE’s Regulatory and Quality Initiatives Featured at the 2023 ISPE Annual Meeting & Expo
  3. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  4. Health Canada on Advanced Manufacturing and Other Trends
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Regulatory
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. ISPE’s Regulatory and Quality Initiatives Featured at the 2023 ISPE Annual Meeting & Expo
  3. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  4. Health Canada on Advanced Manufacturing and Other Trends
View Related Content
Supply Chain
  1. Highlights: 2023 ISPE Annual Meeting & Expo
  2. Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science
  3. Health Canada on Advanced Manufacturing and Other Trends
  4. Eco-friendly Pharma: Sterilization and Sustainable Practices
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Conferences

2023 ISPE Pharma 4.0™ and Annex 1 Conference

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Barcelona, ES

2024 ISPE Facilities of the Future Conference

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San Francisco, CA US

2024 ISPE Aseptic Conference

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Vienna, AT

2024 ISPE Biotechnology Conference

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Boston, MA US

2024 ISPE Annual Meeting & Expo

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Kissimmee, FL US
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Webinars

Upcoming
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Learn How Mechanistic & Hybrid Process Models are Being Applied in Pharma & Biopharma
Learn How Mechanistic & Hybrid Process Models are Being Applied in Pharma & Biopharma Complimentary…
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ISPE Member Benefits and Orientation Webinar
ISPE Member Benefits and Orientation Webinar Complimentary Learning Level: Basic Session Length: 1…
A Women in Pharma Webinar: How to be An Ally
A Women in Pharma Webinar: How to be An Ally Complimentary Learning Level: Basic/Intermediate…
Next-Generation Life Sciences Facilities: Cybersecurity Strategy for Digital Economy Embracing Sustainability
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour In an era marked by rapid…
How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control
Complimentary Learning Level: Intermediate Session Length: 1 hour Building Management Systems (BMS)…
How to Identify, Understand and Solve Hidden Production Issues
How to Identify, Understand, and Solve Hidden Production Issues Complimentary Learning Level…
Ensuring Data Integrity - Trends, Challenges & Best Practices
Ensuring Data Integrity - Trends, Challenges and Best Practices Complimentary Learning Level: Basic…
Unique Glass Primary Containers Identification In Pharmaceutical Fill & Finish Operations: Best Practice for Achieving Product Traceability, Process Visibility & Quality
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Modern drug manufacturing…
ISPE Webinar: ATMP CoP Town Hall
Complimentary Learning Level: Basic Session Length: 1 hour The ISPE Advanced Therapy Medicinal…
Implementing X-Ray for Single-Use Systems Sterilization: Current Status
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Sterilization by gamma…
New Member Orientation Webinar
Complimentary Learning Level: Basic Session Length: 1 hour Join us for the ISPE New Member…
Patient-Centric Specifications from an Industry & Regulatory Perspective
Patient-Centric Specifications from an Industry and Regulatory Perspective Extended Learning…
Workforce of the Future – Adjust Your Company Culture for Success
Power and Led By Women in Pharma ® Complimentary Learning Level: Basic Session Length: 1 hour A new…
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Training Courses

Upcoming
On-Demand
 
ISPE Hands-On Commissioning & Qualification (C&Q), Process Validation, and ATMP Training
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Strasbourg, FR
ISPE Hands-On Aseptic Processing & Pharmaceutical Water Systems and HVAC for Pharma Facilities Training
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Strasbourg, FR
ISPE Hands-On Training
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Illkirch-Graffenstaden, FR
2024 ISPE March Online Live Training
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Online Live, US
2023 ISPE Pharma 4.0™ and Annex 1 Conference - Training
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Barcelona, ES
2024 ISPE Aseptic Conference - Training
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Vienna, AT
ISPE Hands-On Aseptic Processing & Annex 1 and ATMP Manufacturing Training 
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Strasbourg, FR
2023 ISPE December Online Live Training
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Online Live, US
2024 ISPE May Online Live Training
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Online Live, US
2024 ISPE April Online Live Training
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Online Live, US
2024 ISPE February Online Live Training
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Online Live, US
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Good Practice Guide
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C&Q of Pharma Water & Steam Systems 2nd Edition
Good Practice Guide
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Assessing Particulate Containment 2nd Edition
Good Practice Guide
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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
Good Practice Guide
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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
Good Practice Guide
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Management of Engineering Standards
Good Practice Guide
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Operations Management
Good Practice Guide
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Ozone Sanitization of Pharma Water Systems
Good Practice Guide
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Packaging, Labeling, & Warehousing Facilities
Good Practice Guide
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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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Technology Transfer

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Videos

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2023 Category Winner for Innovation: Chugai Pharma Manufacturing Co., Ltd.
2023 FOYA Category Winner for Operations: WuXi Biologics Ireland Limited
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