Turning QbD into a Practical Reality Training Course (T43)

Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.

Pharmaceutical Technology Transfer Training Course (T19)

This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.

Oral Solid Dosage Manufacturing Process Training Course (T10)

This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.

Explore the Programme (ED)

Explore the Programme

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Managing Cross Contamination with Risk-MaPP Training Course (T41)

This course will focus on using the logic diagram, how cross contamination control fits into the Quality System, how health-based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulation a Quality Risk Management Plan.

Implementing Process Analytical Technology Training Course (T29)

This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality....

Combination Products: Challenges and Expectations Training Course (T47)

Combination Products: Challenges and Expectations (T47) Overview With the increasing regulatory scrutiny on combination products, this new highly interactive course provides six (6) different aspects of a combination product which are: Combination Product GMPs Criticality of Design Input and how to....

Clinical Trial Materials Training Course (T13)

In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM and how to implement the plan and troubleshoot. The course will....

HVAC & Environmental Control for Life Science Facilities Training Course (T14)

This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of....

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)

This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and....

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