Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed
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 3-day course will define the requirements for preparation, planning and execution of Validation/Process Validation and how to maintain a state of control. It explores the 3 Stages of the validation product lifecycle, including Process Design, Equipment and Utility Qualification, establishing and implementing Process Performance Qualification (U.S.) or Process Validation (Europe) requirements, and putting in place an Ongoing/Continued Process Verification program. The course is applicable to all sectors of the pharmaceutical industry - small and large molecules, innovators and generics. The content comprises a blend of presentation of concepts and details, followed by related practice application scenarios/exercises.
Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW). This 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 microbial control and laboratory water as well as key design philosophies.
Through lectures and group exercises the course will review regulatory philosophy; aseptic process and equipment considerations; aseptic clean room design and operation; differential pressure requirements; airlocks; basic utility system monitoring; U.S. and European HVAC considerations; C&Q issues, and a brief introduction to barrier isolation technology. An exercise in the layout of an aseptic filling facility will be used to demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage. Additional topics include the use of RABS and isolator systems, and methods for contamination control.
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.