Trainer: Mr. Vincent Cheung
Process validation is an integral part of design control process, contract manufacturing and are regulatory requirements. Participants will learn “how-to” design/prepare for process validation studies, write validation test protocols/reports including the use of risk-based sample size determination for simulated processes, use of statistical software (Minitab®) for analysis and interpretation of data, handling of unanticipated deviations, and good documentation practices. Participants will also learn common mistakes, pitfalls, and consequences when a production process is not properly validated before use.
1) Personnel from finished product manufacturers interested in bringing a new or modified medical device to market.
2) Personnel from contract manufacturers interested in or currently involved in the manufacturing of medical devices for multinational product owners. Typical job functions include but not limited to:
Available Workshops:
Please contact AQS Labs.
Workshop Fee:
S$2200