Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue
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 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.
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.
This new course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”.
The course has been substantially updated to feature the guiding principles of the Water and Steam Systems Baseline® Guide (3rd Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each.
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.
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.
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. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.
This new instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and analytics.