Manufacturing

Through group exercises, this classroom 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.

This classroom 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.

This highly interactive, 3 day advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.

This classroom 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.

This classroom course is designed to provide participants with a deep understanding of how to measure operational excellence including insights on relevant qualitative enablers as well as meaningful quantitative performance indicators.

This classroom 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 Assurance.

In this classroom 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 also cover the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology will be covered to ensure familiarity with all the necessary concepts.

This classroom 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.

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 define the requirements Design Verification and Validation approaches What to expect and considerations for Clinical Trial for Combination Products Human Factors for Combination Products Post Market Considerations An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis for the product, testing, and specifications including....

This classroom 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 the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.