Process Validation Guide – Regulatory Expectations and Best Practices
This web seminar covers the 2011 released U.S. guidance and regulation pertaining to Process Development/Design, Process Validation/Process Performance Qualification and Continued Process Verification. It details regulatory expectations and industry's best practices efforts to establish a Process Validation Program and the inclusion of Risk Management strategies.
This particular session is based on a series of training sessions that was given directly to a team of agents and auditors within the U.S. Food and Drug Administration's (FDA) headquarters in Maryland. This interactive session has been updated and formatted for industry use, detailing proven process validation best practices.
The speaker will cover:
- How industry-leading companies have implemented the new approach-both prospectively and retrospectively
- The successes and benefits of the new approach
- The novel shifts in quality philosophies within industry and the FDA that have facilitated successful implementations
This course will be of benefit to anyone involved in process development, validation, or quality assurance. Additionally, those who will maintain process and product trends for the purpose of demonstrating continuous control will find this course extremely beneficial.
Alfredo Canhoto has over 15 years’ experience in the biotechnology and pharmaceutical industries providing consulting, compliance, audit, and validation engineering services -both domestic and international. He has successfully developed and implemented strategic plans for organizations looking to remediate or establish validation and cleaning programs while improving efficiency and “right first time” metrics.
Dr. Canhoto has developed and implemented commissioning and validation programs using risk-based approaches. In addition, he has worked with multi-national biopharmaceutical companies developing science-based parameters and regimens for the cleaning validation programs, development of process validation plans/programs, and the set-up of laboratory methods validation and instrumentation qualification. He has published numerous peer-reviewed articles and chapters on how biopharmaceutical companies can reduce cycle times and improve the robustness of cleaning regimens. His work has helped clients achieve an overall decrease in validation costs. Dr. Canhoto has developed project schedules for clean utilities, manufacturing processes and equipment and has lead and executed tight timeline commissioning and qualification efforts. Dr. Canhoto has participated in numerous risk assessment efforts and regulatory agency inspections. He currently leads the ProPharma Group’s Technical Solutions consulting practice.
Dr. Canhoto completed his Bachelors of Science and Doctorate in biochemistry from the University of Massachusetts, Amherst and the University of South Carolina, Columbia respectively. He also completed a post-doctoral fellowship at the Dana Farber Cancer Institute at the Harvard Medical School. Dr. Canhoto then managed Cleaning and Validation programs at the companies such as Wyeth Biotech and Genzyme Corporation. Currently, Dr. Canhoto is the Associate Director of Technical Solutions Practice at the ProPharma Group. In that capacity, he is responsible for all the Process and Cleaning Validations, Analytical Instrumentation Qualifications, Environmental Qualification and Monitoring as well as Method Qualification and Validation.