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. Guidance on the transition of an organization’s approach to C&Q to one that incorporates a science and risk-based approach will be discussed including 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.
This 3-day 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; how to maintain an "inspection ready" state; frequency of testing and balancing; airflow visualization and air change rate reduction. A thorough review of global cGMP regulations and their common interpretations and how they can apply to your facility. The course also examines the challenges and some accepted HVAC solutions for a variety of facility types, including: Laboratories, Bulk Pharmaceutical Chemicals (BPC), Bulk Biologics, Vaccines, Oral Dosage Forms (solid and liquid), Sterile fill/finish, Medical Devices and Combination Devices.
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.
Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) has become increasingly important. This course identifies criteria for successful TT and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities.
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.