Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Using the USP, EP, JP Monograph, USFDA Guide to Inspections of High Purity Water Systems, current FDA views and cGMP requirements, this course will provide a sound regulatory framework to understand common water system myths. A variety of practical system designs will be evaluated for compliance, as well as their advantages and disadvantages. Particular attention will be paid to microbial control, laboratory water, key design philosophies, systems and component sanitization procedures, operation, testing and maintenance of equipment and systems for water generation. Examine methods for proper water quality selection, information on compendial and non-compendial water, fundamentals of basic water chemistry and information on common unit operations (deionization, reverse osmosis and distillation). Pre-treatment systems, detailed guidance for selection of construction materials and operation issues related to pharmaceutical water generation systems will also be discussed.
This course will provide an 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 residues. Additional topics covered include a CIP technology review including examples of various pharmaceutical processes that illustrate how CIP technologies and hygienic design can improve cleanability. Other topics for discussion include CIP spray device selection criteria and dynamics of integrating CIP process piping into a pharmaceutical process. A dynamic hands-on workshop will allow participants to work in groups to design, build, and implement a cleaning process for a pharmaceutical application. Participants will apply knowledge gained from the course to identify cleaning solutions to complex cleaning processes.
The 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. Using a Process and Production Video Simulation for Unit Ops, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating and Coating provides participants with a visual demonstration of current manufacturing and engineering practices. The simulation will vividly present real-time experiences for identifying and analyzing the problem identify the root cause and present solutions. A case study for production related issues and concerns will also be utilized.
This three-day course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. This course includes the revised EU GMP Annex 11 and an update on 21 CFR Part 11.
This highly interactive course recommends good practices based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP® 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems and the full system lifecycle from concept to retirement. You will learn how appropriate QRM and specification and verification activities should be an integral part of the normal system lifecycle. The course also promotes leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.
This course will provide you with the essential concepts and principles of specification, design, C&Q of equipment and systems used to store and distribute water in pharmaceutical manufacturing. Additional topics include understanding the importance of microbiological control; analyzing the principles behind water system testing and qualification; the impact of water quality requirements (compendial and non-compendial); basic requirements for water distribution system component installation and overall system construction; integrating and streamlining commissioning and validation activities; and identifying alternative system designs and their advantages and disadvantages.