Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
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.
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including: cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography.
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.
This course provides you with the areas in which compliance requirements differ most from traditional pharmaceutical and biologics and will review common deficiencies and problem areas related to Q7A. Particular focus will be provided for equipment and engineering with recommended systems; controls and procedures to avoid pitfalls; knowing how to ask the right questions based on science and applicable regulations; buildings and facilities; cell culture and fermentation specifications; documentation; risk assessment; manufacturing controls; materials management; packaging; process equipment; in-process controls; qualification/verification and validation; quality management and specifics for clinical manufacturing.
Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.
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.