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 31 Oct - 3 Nov 2023
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.
Overview Biopharmaceutical Manufacturing Processes 6 - 9 Nov 2023
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.
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.
Storage, Delivery, and Qualification Pharma Water 7 - 10 Nov 2023
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.
Pharma Water Generation USP WFI & Purified Water 13 - 14 Nov 2023
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.
This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.
Turning Quality by Design (QbD) into a Practical Reality 27 - 30 Nov 2023
This training course utilizes the ISPE PQLI Guide Series: Part 1 - Product Realization using Quality by Design, Concepts and Principles and Part 2 - Product Realization using Quality by Design, Illustrative Example as the basis for explaining and providing examples of how products and processes can be developed, using QbD with special emphasis on the considerations for implementing these processes in manufacturing.
Commissioning and Qualification 28 Nov - 1 Dec 2023
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.