13 hrs VILT, 1.5 hrs self-paced
This highly participative process validation training course is designed to ensure that you understand the current EU and FDA requirements for the design, execution, assessment and reporting of equipment qualification and process validation studies. Learn how the science and risk-based approach to validation can deliver business efficiency, increase reliability, enable robust processes and assure product quality. Doing so can add real value to your business while providing better protection to patients.
Our tutors are internationally recognized experts in the field and can help you efficiently perform equipment qualification and pharmaceutical validation studies that meet the needs of regulators in the U.S. and Europe.
For example, the 2011 FDA Guidance on Process Validation and the 2015 EU Good Manufacturing Practice (GMP) Annex 15 introduced a new approach to equipment/facility/utility qualification and process validation. This course provides a demonstration of the practical application of the science and risk-based approach to qualification and validation that meets these dramatically revised regulations.
We explain how facility/utility/equipment qualification and process validation must link to patients’ needs and regulatory requirements, using tools such as risk management, statistical data analysis and change management to efficiently accomplish this. Our course shows you how to efficiently plan, design, execute and document qualification/validation activities to new and existing processes with beneficial results.
On completion of this course delegates will know and understand:
This course is ideal for technical and managerial personnel responsible for facility/utility/equipment qualification and process validation, quality assurance personnel and, in particular, Qualified Persons.
Richard Kettlewell - Richard has over 30 years of experience in the pharmaceutical manufacturing sector. He has supported and inspected many sites of varied dosage forms worldwide. Richard has a master’s degree in pharmaceutical sciences and joined the industry in 1986 at GlaxoSmithKline, where he spent 32 years in QC, QA and technical roles. He developed and implemented lifecycle approaches to process validation across R&D and manufacturing organizations and supported new product introductions for both API and secondary filing.
Are you new to the topic of validation? Check out our bite-size introduction to validation training, covering all the core areas. Purchase the bundle or courses individually.
As well as our introductory bite-size cleaning validation course, we offer a comprehensive training that we can deliver to your team in-house and tailor to your requirements.