2025 ISPE November Training
Deep Dive into Pharma Training Courses
Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
- Real World Practice: Courses present exercises that use current problems and situations common to the industry.
- Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
- Global Training to Fit Your Needs: With eLearning
Biopharmaceuticals: CMC Aspects
3 - 6 Nov 2025
This new 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.
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Pharma Water Generation USP WFI & Purified Water
5 - 6 Nov 2025
This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
Instructor
CAPA / RCA / Investigations
10 - 13 Nov 2025
Through lecture and “hands-on” team exercises this course illustrates how a mature Pharmaceutical Quality System utilizes CAPA and Continuous Improvement, how to effectively write and investigate to achieve holistic CAPA, and what PPPQMS can do for your PQS.
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Commissioning and Qualification
10 - 13 Nov 2025
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
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Overview Biopharmaceutical Manufacturing Processes
10 - 13 Nov 2025
Explore commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.
Instructor
Storage, Delivery, and Qualification Pharma Water
17 - 20 Nov 2025
This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.
Instructor
GMP Sterile Pharmaceutical Manufacturing Facility
17 - 20 Nov 2025
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.
Instructor
Aseptic Processing & Annex 1
18 - 19 Nov 2025
Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1. Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers.
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