Content highlights regulations and guidance issued by international regulatory bodies and coalitions. Case studies could demonstrate the application of regulations and industry-generated guidance for global harmonization of compliance and product registration. Topics could include regulations, standards, practices, and guidance related to drugs, the environment, health, and safety.
Initiatives
Current Topics
Guidance Documents
Active Pharmaceutical Ingredients (2)
Advanced Manufacturing (1)
Advanced Therapy Medicinal Products (1)
Biotechnology (3)
Critical Utilities (6)
- Baseline Guide Vol 4: Water & Steam Systems 3rd 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
Drug Shortages (2)
Good Manufacturing Practice (1)
Investigational Products (3)
Knowledge Management (2)
Lifecycle Management (2)
Manufacturing Operations (3)
Microbiological & Viral Contamination Control (7)
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- D/A/CH Affiliate: WFI Handbook (English Translation)
- 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
Quality Assurance (2)
Quality Control (1)
Regulatory (5)
Sterile Products (1)
Supply Chain Management (2)
Community Discussions
Community Discussions
Oct 03, 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
Sep 07, 2024
Quality
Aug 29, 2024
Data Integrity
Pharmaceutical Engineering Magazine Articles
Webinars
ISPE in the News
Latest
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Who Said It? Show up, show up, show up, and after a while the muse shows up, too. If she doesn't show up invited, eventually she just shows up.
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Countdown Timer to Annual Meeting
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Setup and Implementation of Digital Validation Tools
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Pharma 4.0™ Interconnected Facility Design and Construction
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Zambia to produce millions of livestock vaccine doses
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FDA confirms end of shortage for Lilly's weight-loss drugs
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Gilead licenses 6 manufacturers to produce HIV PrEP drug
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Lilly to develop $4.5B drug research, manufacturing hub
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Experts explain how Biopharma 5.0 will work
- US dockworkers suspend strike that would have hit drug supply
White Papers
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
September / October 2023
Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have…
January / February 2022
Emerging Leaders has grown from an initiative for interactions among early-career professionals and…
Videos
iSpeak Blog Posts
Featured Conferences
Pharmaceutical Job Board
Professional Development Training
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…
CAPA / RCA / Investigations Training Course
Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.
Pre-Approval Inspection Readiness Training Course
This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.
Implementation of ICH Q12 Guideline
Delivery Mode: Webinar ISPE Team Assists Training Health Canada with Implementation of ICH Q12 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Regulatory Background International Council for Harmonisation’s (ICH) guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12) provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of ICH’s…
Biopharmaceuticals: CMC Aspects
This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.